Reported trial results for Autism Spectrum Disorder

65 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT06291246 · results posted 10 July 2026

  According to the results reported on ClinicalTrials.gov, this trial involved 25 people in total — 13 in a "Family Navigation" group and 12 in an "Educational Materials" group. Within those groups, participants included both caregivers (7 and 6 respectively) and children (6 and 6 respectively). The trial was looking at how quickly children with autism received their first therapy session after diagnosis, as well as caregiver wellbeing and several measures of how the children were developing. It is worth noting that the data shows zero participants were recorded as having formally "completed" the trial in either group, which may reflect how completion was defined for this particular study. The reported data shows that, for the main thing being measured — the number of days between an autism diagnosis and the start of autism-specific therapy — the Family Navigation group waited an average of 103 days, while the Educational Materials group waited an average of 71 days. For caregiver wellbeing, scores were recorded on a scale of 0 to 110 (where higher numbers indicate better wellbeing, and scores below 61 are described as reflecting "severe distress"). The reported data shows the Family Navigation group averaged a score of 62.5, sitting just within the "moderate distress" range, while the Educational Materials group averaged 72, sitting at the lower edge of the "positive wellbeing" range. Several other planned measurements — including children's developmental functioning, adaptive behaviour, and how appropriate and feasible participants found the intervention — were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06247176 · results posted 29 May 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT06247176) set out to compare how the bodies and brains of people with Autism Spectrum Disorder (ASD) and people without ASD (described as "neurotypical") respond and adapt to repeated sensory stimulation. The study planned to enrol participants into two groups. The reported data shows that only one person started and completed the trial — in the ASD group — and no participants were recorded in the neurotypical group. The reported data shows that no outcome measure results were submitted for any of the four measures the trial intended to track. These were: brain activity changes (measured by an fMRI scanner), skin sweatiness (a marker sometimes used to indicate the body's stress response), skin temperature changes, and heart rate changes — all recorded before, during, and after the sensory stimulation sessions. Because no numerical results were provided for any of these measures in either group, it is not possible to describe what the trial found. Given that only one participant completed the study and no results data was submitted, the trial does not appear to have produced reportable findings in its current form. It is unclear from the information available why the study enrolled so few participants or why outcome data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04655326 · results posted 9 April 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04655326) enrolled 296 participants in a single treatment group, with 170 completing the study and 126 not completing it. The trial was measuring changes in autism-related symptoms, social skills, and gut (gastrointestinal) symptoms in children with autism, as assessed through parent-reported questionnaires. The reported data shows that for the main (primary) outcome — a parent-reported measure called the PGIA-Change, which asks parents to rate changes across 20 autism-related symptoms on a scale from -3 (much worse) to +3 (much better) — the average score reported was 0.36. This sits just above 0, which on this scale represents "no change." For the secondary outcomes, the Social Responsiveness Scale (a questionnaire measuring social difficulties, where higher scores mean more severe concerns, ranging from 0 to 195) showed scores of 80.2 at one time point and 78.6 at another. The Gastrointestinal Symptom Rating Scale (which measures the severity of 15 gut-related symptoms on a scale from 1 meaning none to 7 meaning severe) showed average scores of 2.25 at one time point and 1.96 at another. The reported data does not specify exactly when each of these time points was measured. It is worth noting that this trial had only one group, meaning there was no separate comparison (control) group reported in the submitted results, and the figures above simply describe scores recorded during the study rather than a comparison between a treated and untreated group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05009095 · results posted 23 February 2026

  According to the results reported on ClinicalTrials.gov, this trial looked at a sound-based listening program called The Listening Program®, delivered through bone conduction headphones (headphones that send sound vibrations through the bones of the skull rather than through the ear canal). The trial enrolled 8 participants, all in a single group — meaning there was no comparison group. Six participants completed the trial and two did not finish. The trial was measuring changes in everyday adaptive skills, functional abilities, sensory processing, and autism-related symptoms across multiple time points. The reported data shows the following numbers for the primary outcome — a test called the ABAS-3, which measures everyday adaptive skills on a scale where scores of 90–109 are considered average and 70 or below is described as extremely low. Scores recorded across three time points were 71, 72, and 73.83 out of a possible range of roughly 40 to 160. For the secondary outcome — a test of daily activities and social/cognitive function (PEDI-CAT ASD) scored on a scale of 20 to 80 — the reported data shows six time-point scores of 53.83, 56.00, 56.50, 61.17, 64.50, and 62.84. Two additional measures were also reported: a sensory processing score (where lower means less difficulty) recorded at 70.67, 63.34, and 62.34 across three time points; and an autism symptom checklist score (where lower means fewer reported symptoms) recorded at 57.83, 43.83, and 46.50. The data does not specify which time points correspond to baseline, mid-point, or end of the program. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05555615 · results posted 3 December 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 209 participants who were given pimavanserin. The trial was measuring two things: firstly, how many participants experienced new or worsening side effects after starting the treatment (called "treatment-emergent adverse events"); and secondly, how many participants showed a meaningful improvement in irritability symptoms after 52 weeks, as measured by two standardised rating scales — one completed by a parent or carer (the ABC-I, which scores irritability on a scale where higher numbers mean more severe problems) and one completed by a clinician (the CGI-I, which rates how much a patient's condition has changed compared to the start of the study). The reported data shows that out of the 209 people who started the trial, 67 completed it, while 142 did not complete it (the reasons for this were not detailed in the data provided here). Regarding side effects, 132 out of 209 participants were reported as experiencing at least one treatment-emergent adverse event. For the secondary outcome, 51 participants were reported as meeting the response criteria — meaning they had at least a 25% reduction in their irritability score on the ABC-I scale and were rated as "much improved" or "very much improved" by their clinician at the 52-week mark, compared to where they started before this study. It is worth noting that the data does not break down the nature or severity of the adverse events, nor does it report the total number of participants who were assessed for the secondary outcome measure, so the full picture cannot be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05194345 · results posted 19 November 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 132 participants across two main groups: 64 people in the "Autism Eats" nutrition programme and 62 people in a comparison group called "We Can! Enhanced Usual Care." Within each of these main groups, participants included 25 children, 25 parents, and a number of healthcare providers. The trial was measuring whether a nutrition programme designed for children with autism could change how much fruit and vegetables they ate, how varied their diet was, overall diet quality, and challenging mealtime behaviours. The reported data shows the following changes from the starting point: for fruit and vegetable intake (measured in "cup equivalents" — roughly the amount that would fill a standard cup), children in the Autism Eats group increased by about 0.31 cups per day right after the programme and by about 0.55 cups at the five-month follow-up, while children in the comparison group showed a small decrease of around 0.05 and 0.08 cups respectively. For food variety (the number of different foods eaten each day), the Autism Eats group showed an increase of about 0.86 different foods right after the programme, then a very slight decrease of 0.03 at follow-up; the comparison group showed decreases of 0.36 and 0.73 respectively. For overall diet quality — scored on a 0–100 scale where higher means better — both groups showed small decreases from their starting scores, with the Autism Eats group dropping by about 2.2 points right after and 1.1 points at follow-up, and the comparison group dropping by about 0.5 and 0.6 points. For mealtime behaviours — scored on an 18–90 scale where higher means more challenging behaviours — both groups showed reductions (meaning fewer reported challenging behaviours), with the Autism Eats group dropping by about 5.2 points right after and 3.4 at follow-up, and the comparison group dropping by about 4.3 points at both time points. The reported data also shows results for two secondary measures. For weight-related measurements (based on standard growth charts), the Autism Eats group showed a decrease of about 10.5 percentile points compared to a decrease of about 2.7 in the comparison group, though what these changes mean clinically is not explained in the submitted data. For parenting feeding practices — scored across several areas on a 1–5 scale — small changes in various directions were reported for both groups across different feeding behaviour categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05373173 · results posted 24 August 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at a telehealth-based autism assessment process called TAP-P. A total of 148 participants were enrolled across two groups: 30 children were assessed by telehealth only, and 118 were assessed by telehealth followed by an in-person assessment. Of those, all 30 in the telehealth-only group and 116 of the 118 in the combined group completed the study (2 did not finish). The reported data shows that clinicians rated how certain they felt about their diagnosis on a scale of 1 to 4, where 4 means "completely certain." For the telehealth-only group, the average certainty score was 3.07 (described as "somewhat certain"). For the combined telehealth-plus-in-person group, clinicians scored 2.85 after the telehealth portion, and 3.64 after the additional in-person assessment. Regarding how closely the telehealth assessment's conclusions matched a confirmed diagnosis, the reported figure was 60% agreement in the telehealth-only group, and 81.9% in the combined group. On a parent satisfaction survey, the reported data shows that across several questions, the percentage of parents who answered "very true" to positive statements about the telehealth process ranged from roughly 38.5% to 96.3% in the telehealth-only group, and from approximately 51.8% to 98.2% in the combined group, depending on the specific question asked. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05523895 · results posted 24 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05523895) enrolled 237 people across three groups to look at the effects of two different doses of a medicine called pimavanserin compared to a placebo (a dummy treatment with no active ingredient) in people with challenging behaviours, specifically irritability. The groups were: 78 people received placebo, 78 received a lower dose of pimavanserin, and 81 received a higher dose. By the end of the study, 74, 67, and 75 people in each group respectively had completed the trial. The primary thing being measured was a change in irritability scores on a caregiver-rated questionnaire called the Aberrant Behavior Checklist Irritability (ABC-I) subscale. This is a scale where caregivers rate 15 behaviour-related items, with a total score ranging from 0 (no problems) to 45 (severe problems) — a lower score means less irritability. The reported data shows that after six weeks, the average score change from the starting point was minus 9.6 points in the placebo group, minus 11.2 points in the low-dose pimavanserin group, and minus 11.2 points in the high-dose pimavanserin group. In other words, all three groups showed a reported reduction in irritability scores over the course of the trial. No secondary outcome measure data was reported in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06023563 · results posted 12 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT06023563) enrolled 13 children and young people in total — 7 in a group that used virtual reality (VR) active video gaming and 6 in a group that did standard balance exercises. All 13 participants completed the study with no drop-outs. The trial was measuring balance and walking (gait) at multiple time points, comparing the two groups across several measures including body sway while standing, a structured balance assessment, and various walking measurements such as step length, stride length, step width, and the time both feet are on the ground at once. The reported data shows the following average figures across the two groups at the time points recorded. For postural sway — how much a person's centre of balance moves while standing — the VR group recorded values of 0.93, 1.00, and 1.40 cm/sec across the measurement points, while the standard exercise group recorded 0.50, 0.80, and 0.74 cm/sec. For the Pediatric Berg Balance Scale (a 14-task assessment scored out of 56, where higher means better balance), the VR group scored 51.86, 55.43, and 55.14, while the standard exercise group scored 52.00, 55.00, and 54.67. For walking measures, the reported data shows the two groups had broadly similar figures across time points: step lengths around 0.66–0.71 metres, stride lengths around 1.31–1.38 metres, step widths around 0.11–0.12 metres, and double support time (the brief moment both feet touch the ground while walking) ranging from approximately 0.11 to 0.17 seconds. It is worth noting that with only 13 participants across both groups, this was a very small study, and the reported data does not include information on statistical significance or variability, so these numbers should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06281171 · results posted 21 May 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 115 people in total — 58 in a "Video Library Group" and 57 in a "Flyer Library Group." The trial was comparing two different types of educational resources for building communication and relationship skills: one group received video-based materials, the other received written flyer-based materials. Participants were measured at three points in time across the study, and by the final timepoint, 52 people remained in the video group and 48 in the flyer group. The reported data shows that the main thing being measured was a demonstrated communication skills score, rated on a scale of 0 to 160 (where higher means more skills were shown). At the first timepoint, the video group scored 72.02 and the flyer group scored 79.33. By the second timepoint, those figures were 78.71 and 74.65 respectively, and at the third timepoint both groups scored similarly — 81.04 for the video group and 81.17 for the flyer group. Several additional things were also measured across the three timepoints: confidence in communication skills (scale 24–120), general interpersonal competence (scale 40–200), ability to cope with rejection and jealousy (scale 16–80), and standardised scores for depression and anxiety symptoms. The reported data shows that scores across all of these measures shifted to varying degrees over time in both groups, but the reported figures were broadly similar between the two groups at each timepoint. No data was reported as missing for these outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04654117 · results posted 3 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04654117) involved two groups: one made up of healthcare providers receiving a structured consultation program, and one made up of families receiving a parent-delivered program called Project ImPACT. A total of 20 providers and 21 families started the trial. Of those, 16 providers and 13 families completed it, meaning 4 providers and 8 families did not finish. The reported data shows several things were measured for the provider group. On a treatment adherence checklist scored from 0 to 100 (where higher means more closely following the program), providers scored an average of 62.51. On a separate measure of skill in delivering a coaching-style approach to parents — rated from 1 to 5, where higher means more competent — providers averaged 2.87. Providers also reported what share of their eligible clients they were seeing with this program; on average, that figure was 24.37%. Three different consultation approaches were rated for ease of use on a scale of 0 to 100 (higher meaning easier to use), with scores of 76.78, 60.71, and 72.01 reported. Providers' overall impressions of the Project ImPACT program were measured on a scale of 1 to 7 (higher meaning more positive), with an average score of 3.38 reported. For the families group, children's autism-related behaviours were measured using a tool scored from 82 to 410, where higher scores indicate greater frequency and impact of those behaviours; the reported average score was 40.09. It should be noted that this last figure falls below the stated minimum of the scale, and no explanation for this was provided in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04745026 · results posted 30 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04745026) enrolled 103 participants in total — 49 in the GWP42003-P (cannabidiol) group and 54 in the placebo group. Of those, 36 and 41 respectively completed the study. The trial was measuring changes in behaviour, daily living skills, and overall clinical impression in people with intellectual and developmental disabilities, using several standardised rating scales completed by caregivers and clinicians over 12 weeks. The reported data shows the following for the main (primary) outcome measures. On the Aberrant Behavior Checklist — which rates problem behaviours like irritability, social withdrawal, and hyperactivity — both groups showed reductions (improvements) in scores over time, but the numbers were similar between the two groups at most time points. For the Vineland Adaptive Behavior Scales — which measures communication, daily living, and socialisation skills on a scale where higher scores are better — both groups showed small increases (improvements) in scores, again with broadly comparable numbers between groups. For the clinician-rated impression of overall change (CGI-I), the reported data shows that across both groups, roughly similar numbers of participants were rated as improved, minimally improved, or unchanged, with very few rated as worse in either group. On the clinician-rated severity scale (CGI-S), both groups showed small reductions in severity scores across the 12 weeks, with the reported numbers looking very similar between the GWP42003-P and placebo groups. Regarding the secondary outcome of adverse events (unexpected health changes during the study), the reported data shows that 27 participants in the GWP42003-P group and 24 in the placebo group experienced at least one such event; the data also includes breakdowns by seriousness and other categories. Blood test changes were also recorded and reported, though the clinical significance of those figures is not described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04349644 · results posted 7 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04349644) looked at a programme called SENSE Theatre — a theatre-based activity — for adults with autism spectrum disorder (ASD). A total of 64 people started the study across two groups: 29 were assigned to take part in SENSE Theatre straight away, and 35 were placed on a waitlist (a comparison group who waited before receiving the programme). The trial tracked whether taking part in the programme was linked to changes in things like remembering faces, social skills observed in conversation, and how participants and their caregivers rated social abilities using a standard questionnaire. The reported data shows the following numbers at the various time points measured. For the brain-activity-based face memory task (which measured electrical signals in the brain in millionths of a volt), the SENSE Theatre group showed a reported value of around 0.66 at post-programme and 0.47 at follow-up, while the waitlist group showed values of around −0.16 and −0.77 at those same points — where a positive number was described as indicating better face memory in this particular task. For the observed social skills during a conversation (rated on a 1–7 scale, with 7 being the highest), both groups reported scores roughly in the 4.3–5.4 range across time points. On the standardised social questionnaire filled in by participants themselves (scored 38–90, where lower scores suggest fewer difficulties), the SENSE Theatre group reported scores moving from about 63.2 to 62.8, and the waitlist group from about 67.5 to 65.8. Caregiver-rated scores on the same questionnaire moved from about 65.5 to 64.0 for the SENSE Theatre group and from about 66.2 to 64.9 for the waitlist group. For the secondary face memory tests, scores across both groups were broadly similar at both time points, ranging roughly from 45 to 49 out of 72 on one test and around 8 out of 19 on the delayed memory test. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04295512 · results posted 27 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04295512) looked at a programme called "Unstuck and On Target," which is designed to support children with certain behavioural and mental health challenges. The trial involved two main groups: therapists (18 in the usual care group and 23 trained in the Unstuck and On Target programme) and children (12 in the usual care group and 22 in the Unstuck and On Target group). The study measured three main things: how acceptable, appropriate, and feasible the therapists found the programme; how closely therapists followed the programme's intended steps (called "fidelity"); and changes in children's reported behavioural and emotional difficulties over time. The reported data shows that therapists trained in Unstuck and On Target rated the programme quite positively on all three perception measures — scoring an average of 4.58 out of 5 for acceptability, 4.62 out of 5 for appropriateness, and 4.50 out of 5 for feasibility (where 5 means "completely agree" that the programme meets that standard). When it came to how closely therapists stuck to the programme's steps during sessions, Unstuck and On Target therapists scored between roughly 3.26 and 4.74 out of 5 across different components, compared to usual care therapists who scored between approximately 1.25 and 2.10 on those same components. For children's behaviour as reported by parents, both groups showed a decrease in scores (meaning fewer reported difficulties) from the start of the study to six months later — the usual care children's group showed decreases of 4.54, 2.64, and 5.36 points across three behaviour scales, while the Unstuck and On Target children's group showed decreases of 2.33, 1.67, and 1.87 points on the same scales. On a separate questionnaire measuring disruptive behaviours specifically, the usual care children's group showed a decrease of 7.09 points, while the Unstuck and On Target children's group showed a small increase of 1.85 points. The data does not include further detail explaining these differences. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04294290 · results posted 24 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04294290) enrolled 12 participants, all of whom completed the study — none dropped out. The trial involved infusions of a cell-based treatment called hCT-MSC (stem cells derived from umbilical cord blood). The study was set up to track a number of specific events that researchers wanted to count and measure after the infusions were given. The reported data shows the following counts from across all 12 participants: there was 1 infusion reaction recorded in total, and its severity was rated as 1 on the CTCAE scale — a standardised 1-to-5 scoring system where 1 means mild and 5 means death. No infections thought to be related to the treatment product were recorded (a count of zero). The severity score for product-related infections was not reported in the data, likely because none occurred. Two participants showed signs of a process called alloimmunisation — meaning their immune system appeared to have developed antibodies in response to proteins on the infused cells, which researchers were monitoring as a potential concern. No cases of graft versus host disease — a condition where donated cells attack the recipient's body — were recorded (again, a count of zero). It is worth noting that this was a small trial of only 12 people, and the results presented here are simply counts of specific events that were monitored. The reported data shows what was observed and recorded during this trial; it does not on its own tell us how these numbers compare to what might happen without the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04299464 · results posted 28 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04299464) enrolled 104 people across three groups: 34 received a placebo (dummy treatment), 34 received a lower dose of alogabat (20 mg), and 36 received a higher dose of alogabat (60 mg). The trial ran for 12 weeks and was primarily measuring changes in everyday adaptive skills — things like communication, socialising, and daily living — using a standard interview-based tool called the Vineland-3, which produces a score to track an individual's progress over time. By the end of the study, 32 participants in the placebo group, 30 in the 20 mg group, and 29 in the 60 mg group had completed the trial. The reported data shows that, on the primary measure (the Vineland-3 adaptive behaviour score, where higher numbers mean better everyday functioning), all three groups showed a small increase from their starting point over 12 weeks. The placebo group's score increased by an average of 3.25 points, the 20 mg alogabat group by 2.82 points, and the 60 mg alogabat group by 2.81 points. The reported data also shows that when it came to adverse events (any unwanted medical occurrence noticed during the trial), 24 of 34 placebo participants, 22 of 34 in the 20 mg group, and 22 of 36 in the 60 mg group experienced at least one such event. No participants in any group experienced a serious adverse event, and very few stopped the trial because of an adverse event (1 in the placebo group, none in the 20 mg group, and 2 in the 60 mg group). A small number of participants across all groups were flagged on a suicidal ideation monitoring scale during the trial, and changes in daytime sleepiness scores were also tracked, with the reported numbers varying modestly across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02675933 · results posted 9 December 2024

  According to the results reported on ClinicalTrials.gov, this trial involved 63 people in total, split into two groups: 32 in a "Standard of Care" group and 31 in a "Questionnaire" group. All 63 participants completed the study, with no drop-outs recorded. The trial was measuring how satisfied parents were with their child's care, comparing those who received standard care to those who also completed a questionnaire as part of their care. The reported data shows that satisfaction was measured using something called a Likert scale — a simple numbered rating system running from 1 to 5, where a score of 5 means the highest level of satisfaction and 1 means the lowest. The Standard of Care group reported an average satisfaction score of 4.1 out of 5, while the Questionnaire group reported an average score of 4.5 out of 5. No other outcome measures were included in the submitted results data. The trial did not report any additional figures beyond these two average scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03569176 · results posted 23 September 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a wearable smart-glasses device (referred to as "Autism Glass") designed for children with autism. The trial used a crossover design, meaning some participants used the glasses first and others acted as a comparison group before later switching over. A total of 71 children were enrolled across both groups at the start (40 in the glasses group and 31 in the comparison group), though the number who completed all stages was lower — 24 in the glasses group and 12 in the comparison group finished through to week 12. The trial measured changes in social skills, emotion recognition, and behaviour-related scores over six weeks. The reported data shows the following scores at baseline and at week six. For the Vineland Adaptive Behavior Scales socialization subscale (where higher scores indicate better social functioning), the glasses group started at an average of 68.75 and moved to 71.72, while the comparison group started at 70.40 and moved to 68.60. For the Social Responsiveness Scale (where lower scores indicate better social skills), the glasses group went from 80.68 to 78.40, and the comparison group went from 80.76 to 81.79. For the Emotion Guessing Game — a 40-question test of emotion recognition where higher scores are better — the glasses group went from an average of 22.80 to 30.03, and the comparison group went from 24.74 to 26.88. For the secondary measures, the full Vineland scale scores showed very little change in either group, and the Child Behavior Checklist scores showed a small decrease in both groups. The BOSCC (a play-based observation measure) had no data reported for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03368001 · results posted 26 August 2024

  According to the results reported on ClinicalTrials.gov, this trial compared two programmes for young people — one called **SENSE Theatre** and one called **Tackling Teenage Together**. A total of 290 participants were enrolled at the start (144 in the SENSE Theatre group and 146 in the Tackling Teenage Together group). The trial was measuring things like face memory (the ability to recognise and remember faces), social communication skills, adaptive behaviours such as communication, and social interaction skills, as rated by parents and observers and measured through brain-activity tasks. The reported data shows the following numbers across the two groups. For one of the two main (primary) face-memory measures — the brain-activity task — the SENSE Theatre group recorded values of 0.74 before the programme and 0.12 afterwards, while the Tackling Teenage Together group recorded −0.22 and 0.01 respectively (positive values were described as indicating better face memory). The results for the other primary face-memory measure were not reported in the data submitted to ClinicalTrials.gov. For the secondary measures, parent-rated social communication scores (where lower numbers mean fewer difficulties) were similar across both groups before and after the programmes. Scores for communication skills on the adaptive behaviour scale (where higher is better) moved from around 6.5 to 7.3 in the SENSE Theatre group and from 6.4 to 6.8 in the Tackling Teenage Together group. Parent-rated social problems scores and observed social interaction scores showed only small changes across both groups, with the reported numbers remaining in a similar range from before to after the programmes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05472870 · results posted 21 August 2024

  According to the results reported on ClinicalTrials.gov, this trial involved 30 children diagnosed with autism spectrum disorder (ASD). All 30 participants completed the study — none dropped out. The trial used a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS), which delivers gentle magnetic pulses to specific areas of the brain. The study measured changes in social behaviours, autism-related symptoms, attention, language, and thinking skills using a series of standard questionnaires and tests, collected at the start of the study, after treatment, and again one month later. The reported data shows the following numbers across the measurement points (before treatment, after treatment, and at one month follow-up where available). On the Social Response Scale (SRS) — a parent questionnaire where higher scores mean greater social difficulty, out of a possible 195 — scores were reported as 94.27 at the start, 81.50 after treatment, and 77.67 at one month follow-up. On the Childhood Autism Rating Scale (CARS), where higher scores out of 60 indicate more severe symptoms, scores were 33.48 at the start and 32.83 after treatment. For the executive function measure (BRIEF), school-age children scored 153.76, 152.76, and 149.12 across the three time points, while preschool-age children scored 115.30, 117.60, and 112.00 (higher scores indicate greater difficulty). On the hyperactivity questionnaire (PSQ Hyperactivity Index), scores were 1.20, 1.18, and 1.10 across the three points. For the vocabulary comprehension test (PPVT), where higher scores are better, scores went from 67.78 to 76.11. On the language development measure (CCDI), scores went from 733.00 to 771.50. The reported data does not include statistical context (such as whether any differences between time points were considered meaningful by the researchers), so these numbers are presented here as recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01985308 · results posted 7 August 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT01985308) involved 28 children in total — 14 in an active treatment group (MRT-Active) and 14 in a sham (inactive/placebo-like) treatment group (MRT-SHAM). All 28 children completed the study. The trial was measuring autism symptom severity using a tool called the Childhood Autism Rating Scale, 2nd Edition (CARS2), which scores behaviours across 15 areas on a scale from 15 to 60 — where a higher score means more severe symptoms. The main question being examined was how much the CARS2 score changed from the start of the study to the end of a five-week blinded phase (where neither participants nor researchers knew who received which treatment). The reported data shows that, on average, children in the active treatment group had a change in CARS2 score of −7.68 points (meaning their scores went down, indicating fewer reported symptoms on the scale) between the start of the study and Week 5. Children in the sham group had an average change of −1.61 points over the same period. The reported data also shows some additional (post-hoc, meaning after-the-fact) measurements taken at Week 10, after all participants had received active treatment: approximately 71.4% of participants who completed Week 10 showed improvement in the "visual response" sub-category of the scale, and approximately 66.0% showed improvement in the "verbal communication" sub-category. It is worth noting that this was a small study with only 14 children in each group, and the post-hoc results at Week 10 were reported for all participants combined rather than broken down by original group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02487082 · results posted 6 June 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02487082) enrolled 12 participants across two groups — 4 in Group A and 8 in Group B — during an initial run-in phase. The trial was measuring behaviours related to social withdrawal, repetitive movements, and sleep in children with autism, using a set of standard questionnaires completed by parents and clinicians. By the final phase, 2 participants remained in Group A and 6 in Group B. Because this was a very small trial, the numbers below should be understood in that context. The reported data shows the following scores at the end of the trial. For the main (primary) outcome — a scale measuring lethargy and social withdrawal, where scores can range from 0 (no concerns) to 48 (most severe) — Group A recorded an average score of 6 and Group B recorded 5.5. For repetitive or stereotyped behaviours (scored 0–21), Group A averaged 6 and Group B averaged 2.5. For sleep duration, Group A averaged 8.75 hours and Group B averaged 6.9 hours. On a clinician's overall impression of change (scored 1–7, where 4 means "no change" and lower numbers mean improvement), Group A averaged 3 ("minimally improved") and Group B averaged 5 ("minimally worse"). On the same scale rated by parents, Group A averaged 2.8 (between "much improved" and "minimally improved") and Group B averaged 3.5 (between "minimally improved" and "no change"). The data was not reported in a way that explains what treatment each group received, so direct comparisons between groups cannot be made from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04258839 · results posted 30 May 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04258839) involved 95 participants in total — 49 who had previously received brexpiprazole (the study drug) in an earlier trial, and 46 who had previously received a placebo (a dummy treatment). All 95 entered the main study period, and 70 completed it (39 from the prior brexpiprazole group and 31 from the prior placebo group). The trial was focused on monitoring and measuring a range of health and safety indicators while participants continued or began taking brexpiprazole. The reported data shows that across both groups, the trial tracked unwanted medical events (called adverse events), physical signs like blood pressure and heart rate, heart electrical activity (via ECG recordings), blood and urine test results, physical examination findings, and thoughts of self-harm. In terms of unwanted medical events during the trial: 23 out of 49 participants in the prior brexpiprazole group and 24 out of 46 in the prior placebo group experienced at least one such event. Of these, 2 participants in each group had a serious adverse event, and 2 and 4 participants respectively stopped the trial because of an adverse event. For vital signs, small numbers of participants in both groups — ranging from 0 to 5 depending on the specific measurement — had readings flagged as potentially clinically notable. Similarly, small numbers had notable ECG readings or laboratory test results flagged. Six participants in the prior brexpiprazole group and 4 in the prior placebo group had abnormal physical examination findings noted. Regarding thoughts of self-harm, 4 participants in the prior brexpiprazole group and 2 in the prior placebo group were recorded as having at least one occurrence of suicidal ideation or suicidal behaviour during the trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04772898 · results posted 18 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04772898) involved 30 children in total — 15 children diagnosed with Autism Spectrum Disorder (ASD) and 15 children with typical development (meaning no ASD diagnosis). The trial was measuring three main things: social traits and behaviours (using a parent-rated questionnaire called the Social Responsiveness Scale, or SRS), balance and postural control while standing still, and how in sync the heartbeats of a child rider and a horse were during equine (horse-assisted) sessions. Twenty-nine of the 30 children completed the study — one child from the typical development group did not finish. The reported data shows that on the SRS questionnaire — where higher scores indicate more autism-related traits, on a scale of 0 to 195 — children with ASD scored an average of 89.06 points at one time point and 79.8 points at another, while children with typical development scored 16.5 and 14.5 points at those same time points. For the balance measure (recorded with eyes closed, where higher numbers suggest faster postural adjustments), children with typical development recorded 0.525 and then 0.53 Hz, while children with ASD recorded 0.48 and then 0.57 Hz. For the heart rate synchrony between horse and rider — where lower numbers mean the two heartbeats were more in sync — the reported data shows children with ASD recorded values of 0.685, 0.644, and 0.681 across three sessions, while children with typical development recorded 0.512, 0.578, and 0.564 across those same sessions. For the two secondary outcomes (a caregiver behaviour checklist and a measure of how horse temperament related to outcomes), no numerical data was reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02428205 · results posted 4 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02428205) looked at whether propranolol (a medication more commonly known for heart and blood pressure conditions) might affect social functioning and related behaviours in participants. A total of 9 people were enrolled — 5 in the propranolol group and 4 in the placebo (dummy treatment) group. Of those, only 3 in the propranolol group and 2 in the placebo group completed the study, meaning this was a very small pilot trial and a notable number of participants did not finish. The reported data shows results across several questionnaire-based measures. For the primary outcomes: on the General Social Outcome Measure (GSOM — a directly observed test of social skills scored from 6 to 132, where higher means better), the propranolol group averaged 48.3 and the placebo group averaged 20.0. On the Social Responsiveness Scale (SRS — a 65-item parent-report questionnaire scored 0 to 195, where lower means better), the propranolol group averaged 79.3 and the placebo group averaged 72.0. For the secondary outcomes, the reported data shows: anxiety (Preschool Anxiety Scale, 0–112, lower is better) averaged 87.7 versus 71.5; behavioural concerns (Aberrant Behavior Checklist, 0–174, lower is better) averaged 72.7 versus 53.0; adaptive social functioning (Vineland scales, 20–160, higher is better) averaged 70.7 versus 66.5; and autism-related peer interaction impact (Autism Impact Measure, 0–40, lower is better) averaged 23.7 versus 24.5, for the propranolol and placebo groups respectively. It is important to note that because so few people took part and even fewer completed the study, the reported numbers reflect a very small group and should be understood in that context. The trial does not provide enough information to draw broad conclusions, and no data was reported on how these scores changed over time — only the scores themselves are available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03459625 · results posted 13 November 2023

  According to the results reported on ClinicalTrials.gov, this trial involved 118 parents in total — 60 in a Mindfulness-Based Stress Reduction (MBSR) group and 58 in a Psychoeducational Support group. Almost all participants finished the trial (59 and 58 respectively). The trial was measuring two main things: children's "externalising" behaviours (things like aggression or acting out, as rated by parents using a standard checklist) and the level of stress experienced by the parents themselves. Scores were collected at what appear to be multiple time points across the study. The reported data shows that children's behaviour scores were tracked using a standardised scale where the general population average is 50, scores of 60–63 are considered "borderline" concerning, and scores above 63 are considered in the "clinical" range. At the start of the trial, both groups had scores well above 63 — 68.40 for the MBSR group and 66.49 for the Psychoeducational group. The reported data shows that at the later time points measured, scores for both groups were recorded in the range of roughly 61 to 65, sitting around or within the borderline range. These are the numbers as submitted; the data does not include details about whether any differences between the two groups were considered meaningful by researchers. For parenting stress (measured on a scale of 12 to 60, where higher means more stress), the reported data shows that at the start, both groups scored similarly at around 37.5. At a later time point, the MBSR group's score was reported as approximately 28.8 and the Psychoeducational group's score as approximately 33.2. No further breakdown of these figures was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01985022 · results posted 9 June 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT01985022) involved 33 young children who had been diagnosed with, or were at risk of, autism spectrum disorder. The children were split into two groups: 16 received a group-based early social interaction (ESI) program, and 17 received a combination of individual and group ESI. The trial tracked the children across several time points, measuring their social communication skills, autism-related behaviours, developmental abilities, and everyday adaptive behaviours. By the end of the study, 12 children in the group-only arm and 14 in the combined arm had completed the trial, with a small number not completing in each group. The reported data shows scores across four main measurement tools. For social communication (CSBS), where a score of 100 is considered average, both groups started below average (around 79–80) and their scores at later time points ranged from roughly 85 to 91. For autism-related behaviours (ADOS), where a score of 6–10 suggests signs of autism, both groups began with scores around 3.75–3.88, which rose to around 5.1–5.2 at one point, then were reported at approximately 3.8–4.5 at the final time point. For developmental learning (Mullen Scales), where 50 is average, scores across different areas generally started below 50 and some scores moved closer to or above 50 over time. For everyday adaptive behaviour (Vineland II), where 100 is average, both groups began with scores in the high 80s, and the reported final scores ranged from roughly 84 to 91. The reported data shows that scores on these measures changed over time for both groups, though the data as submitted does not include a direct statistical comparison between the two groups' results. The expressive language outcome was listed as a measure but no numbers were reported for it in the submitted data, so those results are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03715153 · results posted 5 June 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03715153) looked at a medicine called bumetanide (also referred to as S95008) in children with autism. The trial had two phases: a 26-week blinded phase — where neither the participants nor the researchers knew who was receiving the medicine or a dummy tablet (placebo) — followed by a 26-week open-label phase where everyone received the active medicine. In the blinded phase, 107 children were assigned to bumetanide and 104 to placebo. The main thing the trial was measuring was change in autism-related behaviours using a rating scale called the CARS2, which runs from 15 (behaviour within normal limits) to 60 (severely abnormal behaviour). A decrease in score from the starting point was considered a better result. The reported data shows that by the end of the 26-week blinded phase, the average CARS2 score decreased by 3.66 points in the bumetanide group and by 3.88 points in the placebo group. On a secondary measure of social difficulties (the SRS-2, scored from 65 to 260), the bumetanide group showed an average decrease of 16.3 points and the placebo group an average decrease of 18.7 points. A clinician's overall impression rating (CGI-I, scored 1–7, where lower is better) averaged 2.9 for bumetanide and 3.1 for placebo. A measure of everyday adaptive behaviours (VABS II) showed an average increase of 1.1 in the bumetanide group and 0.7 in the placebo group — noting that for this scale, a decrease would have been the better direction. On heart-tracing tests (ECGs), zero participants in either group had clinically significant abnormalities recorded. On a scale measuring suicidal thoughts or behaviours, zero participants in both groups reported any such concerns across most measurement points; one participant in the placebo group was noted at one time point, while the bumetanide group recorded zero at all reported time points. Some suicidal behaviour data was noted as not applicable (NA) and was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04764539 · results posted 9 May 2023

  According to the results reported on ClinicalTrials.gov, this trial involved six children aged 4 to 8 years, split into two groups of three. One group received speech therapy materials shown on a 2D iPad Pro screen, while the other group received the same materials through 3D virtual reality (VR) goggles and special bone-conduction headphones (which deliver sound through vibrations in the skull rather than through the ears). The trial was measuring several aspects of how the children spoke before and after the sessions, including the average length of their spoken sentences, how accurately a speech-recognition program could transcribe what they said, how correctly they produced individual speech sounds, how many different words they used, and how often they responded to the therapy prompts. Parents were also asked to rate any changes they noticed in their child's communication. The reported data shows the following changes from before to after the sessions. For average sentence length (measured in units called "morphemes," which are the smallest meaningful parts of words), the iPad group showed a change of about 0.54 morphemes per utterance, compared to about 0.30 for the VR group. For how accurately a speech-recognition program transcribed the children's words, the iPad group showed a change of roughly 1.4 percentage points, while the VR group showed a change of 0 percentage points. For correctness of individual speech sounds, the iPad group showed a change of about 19.75 percentage points and the VR group about 16.24 percentage points. The number of different words used changed by about 30 for the iPad group and about 22 for the VR group. The number of times children responded to prompts increased by about 5.67 for the iPad group and 3.33 for the VR group. Parents of the iPad group reported a mean score of 11 out of a possible 18 for positive communication changes, while parents of the VR group reported a mean score of about 9.67. It is important to note that with only three participants in each group, these numbers represent a very small snapshot and the reported data shows changes in measurements only — they do not on their own tell us why those changes occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03242772 · results posted 9 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03242772) involved 18 young children in total — 9 in each group. All children received a parent coaching program based on the Early Start Denver Model (ESDM), a structured approach to supporting early development. One group also received amphetamine medication, while the other received a placebo (a dummy pill with no active ingredient). The trial was measuring things like how well children engaged jointly with their parents, communication and social behaviours, attention-related symptoms, and where children directed their gaze during social situations. Of the 18 who started, 14 completed the trial — 6 in the amphetamine group and 8 in the placebo group. The reported data shows mixed results across the outcomes measured. For communication and social behaviour (measured using a standardised questionnaire called the Vineland Adaptive Behavior Scale), the amphetamine group showed an average change in score of +5.92 points, compared with +1.86 points in the placebo group — where higher scores indicate more adaptive functioning on a scale of 20 to 140. For attention-related symptoms (measured using the ADHD Rating Scale, where lower scores indicate fewer symptoms on a scale of 0 to 54), the amphetamine group showed an average change of −10.00 points and the placebo group showed an average change of −4.75 points. For the two other outcomes — the quality of joint engagement between parent and child, and eye gaze tracking — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04151290 · results posted 28 December 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT04151290) enrolled 711 children and looked at a digital assessment tool called the Cognoa Assessment, which was being evaluated as a way to help identify whether a child might have autism spectrum disorder (ASD). Of the 711 children who started the study, 425 completed it and 286 did not finish. The trial was measuring how accurately the device's result matched the conclusion reached by a specialist clinician doing a full diagnostic evaluation. The reported data shows that, among children who received a result from the device, it correctly identified children who did have ASD (called "positive predictive value") 80.8% of the time, and correctly identified children who did not have ASD (called "negative predictive value") 98.3% of the time. However, the reported data also shows that 68.2% of children received no result at all from the device — meaning for more than two-thirds of participants, the tool did not produce an outcome either way. For the secondary measures, the device's "sensitivity" — how well it picked up children who truly had ASD — was reported at 51.6%, and its "specificity" — how well it correctly identified children who did not have ASD — was reported at 18.5%. It is worth noting that the very high "no result" rate means these accuracy figures apply only to the smaller group of children for whom the device did produce a result, not to all 711 children who participated. No conclusions about whether the tool should be used in any particular situation can be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03611075 · results posted 23 July 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03611075) enrolled 144 participants across nine groups. These included children, adolescents, and adults — some with high-functioning autism spectrum disorder (ASD), some with low-functioning ASD, and some healthy participants included for comparison. In total, 144 people started the study and 133 completed it. The trial was not testing a treatment; rather, it was measuring and describing repetitive and rigid behaviours across different age groups and functioning levels of ASD, using six different rating scales completed by clinicians, caregivers, or participants themselves. The reported data shows scores across all six primary measurement tools at two time points. On the CY-BOCS-ASD scale (which runs from 0 to 20, with higher scores meaning more severe repetitive behaviours), scores at the first time point ranged from about 14.6 to 15.8 across the ASD groups, and from about 13.0 to 15.5 at the second time point. On the MERS-R rigidity scale (0 to 48), first time point scores ranged roughly from 22.6 to 29.9, and second time point scores from about 21.1 to 28.8. On the RBS-R caregiver questionnaire (0 to 129), scores ranged from about 33 to 57 at the first time point and 32 to 54 at the second. On the caregiver-reported RBQ-2 (20 to 60), scores ranged from roughly 34.5 to 41.8 at the first time point and 37.1 to 41.9 at the second. The self-reported adult version (RBQ-2A, also 20 to 60) showed scores between about 35.5 and 40.7 at the first time point, with some variation across visits. On the CRI-R routine and repetitive behaviour scale for children and adolescents (62 to 310), scores ranged from roughly 164 to 188 at the first time point and 161 to 190 at the second. The reported data shows scores were broadly similar across the two time points for most groups, though no comparison to the healthy control groups was included in the figures submitted for these outcome measures. It is worth noting this study appeared to focus on describing and measuring these behaviours across age and functioning groups rather than trialling a specific intervention, and the healthy control group scores were not reported for the primary outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03537261 · results posted 29 June 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 80 parents in total — 41 in a group that received a parent training programme called CPI-Parent Training, and 39 in a waitlist control group (meaning they waited and did not receive the programme during the study period). By the end of the study, 33 parents in the training group and 27 in the waitlist group had completed the trial. The trial was measuring three things: parents' confidence in managing their child's behaviour, parents' stress levels, and overall family quality of life — all assessed using standardised questionnaire scales. The reported data shows the following changes in scores from the start of the study. For parental confidence (scored on a scale of 16 to 160, where higher means more confident), the training group's average score changed by +8.3 points, while the waitlist group's changed by +2.5 points. For parenting stress (scored 36 to 180, where higher means more stress), the training group's average score changed by −2.7 points and the waitlist group's by −0.5 points — meaning both groups reported slightly lower stress on average, with the training group showing a somewhat larger decrease. For family quality of life (scored 25 to 125, where higher means better quality of life), the training group's average score changed by +1.9 points and the waitlist group's by +1.3 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03195465 · results posted 13 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03195465) involved a group receiving cacao (a cocoa-based product) and was set up to measure behaviour in participants using a tool called the Aberrant Behavior Checklist (2nd Edition). This checklist covers five areas of behaviour: irritability, social withdrawal, repetitive (stereotypic) behaviour, hyperactivity and non-compliance, and inappropriate speech. It consists of 58 questions and is a commonly used research instrument for assessing these kinds of behaviours. The reported data shows that zero participants were recorded as having started, completed, or left the study early. In other words, the participant count across all stages of the trial is listed as zero. For the primary outcome — the Aberrant Behavior Checklist scores — no measurements were reported in the submitted data. It is not possible to describe any numerical findings because none were provided in the results submitted to ClinicalTrials.gov. Because no participant data or outcome measurements appear to have been submitted, there is nothing further that can be drawn from the reported results of this trial. The data was not reported rather than showing a particular result, and no conclusions about the cacao intervention can be taken from what has been submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00467818 · results posted 16 December 2020

  According to the results reported on ClinicalTrials.gov, this trial looked at omega-3 fatty acids (fish oil-type supplements) compared to a placebo (an inactive substitute) in children or individuals with autism. A total of 17 people started the trial — 9 in the omega-3 group and 8 in the placebo group. Twelve people finished the study (6 in each group), with 3 dropping out of the omega-3 group and 2 from the placebo group. The trial was measuring things like overall impressions of change, behaviour (such as irritability, hyperactivity, and aggression), daily living skills, and stress levels in parents. The reported data shows the following numbers at the end of the study. On the Clinical Global Impression scale — where lower numbers mean more improvement and 4 means "no change" — the omega-3 group scored an average of 3.57 and the placebo group scored 3.8. On the Aberrant Behaviour Checklist (which looks at behaviours like irritability and hyperactivity, where lower scores suggest fewer concerns), the omega-3 group averaged 5.66 and the placebo group averaged 8.5. On the Vineland Adaptive Behaviour Scale (which measures daily living and social skills, where higher scores reflect better functioning and 100 is considered average), the omega-3 group scored 51.5 and the placebo group scored 27.5. For the secondary measures, the aggression scale (higher meaning more aggression) showed 3.8 for the omega-3 group and 2.4 for the placebo group. The parental stress scale (higher meaning more stress, with scores ranging from 101 to 505) showed 314.2 for the omega-3 group and 279.5 for the placebo group. It is worth noting that this was a very small trial with only 12 people completing it, and the results as reported on ClinicalTrials.gov do not include any explanation of whether the differences between groups were considered meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02561481 · results posted 25 November 2020

  According to the results reported on ClinicalTrials.gov, this trial investigated a compound called sulforaphane (a natural substance found in broccoli sprouts) compared to a placebo (an inactive treatment) in people with autism spectrum disorder (ASD). The trial ran in three phases: a small pilot phase involving 10 participants who received sulforaphane; a double-blind phase (where neither participants nor researchers knew who received which treatment) involving 25 people in the sulforaphane group and 25 in the placebo group; and an open-label phase (where everyone knew the treatment being given) involving 45 participants on sulforaphane. In total, across the main double-blind phase, 22 of 25 in the sulforaphane group and 23 of 25 in the placebo group completed the trial. The reported data shows that the primary measure — a clinician's rating scale called the OACIS-I, which scores overall change in autism-related symptoms from a range of worsening to improving — recorded average scores close to zero for both groups across the trial visits, meaning both groups were rated as close to "no change" on average. For the secondary measures, a behaviour checklist (ABC, scored 0–174 where lower is fewer concerns) showed reductions from baseline in both groups at most time points — for example, at one mid-trial visit the sulforaphane group's score dropped by around 36 points and the placebo group's by around 22 points, though the pattern varied across visits. A social behaviour scale (SRS-2, scored 0–180 where lower means fewer concerns) also showed reductions in both groups at several time points. The reported data also shows that blood levels of a marker indicating sulforaphane was absorbed were higher in the sulforaphane group during the treatment period compared to the placebo group, though these levels appeared to fall after treatment ended. Scores on the aberrant behaviour and social communication subscales of the OACIS-I were also reported for both groups across visits, with both groups showing relatively small average scores close to zero. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03786744 · results posted 19 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03786744) enrolled 20 children with Autism Spectrum Disorder (ASD) — 10 in each group. One group received injections of cord blood mononuclear cells (a type of cell derived from umbilical cord blood), while the other group received standard therapy. All 20 participants completed the trial. The study was measuring two main things: whether any unwanted reactions occurred within 24 hours of the infusion, and changes in ASD symptom severity over time using a scoring tool called the Autism Treatment Evaluation Checklist (ATEC), where a lower score means less severe symptoms (the scale runs from 0 to 179). The reported data shows that zero participants in either group experienced any adverse events (unwanted reactions) in the 24 hours following the infusion. For the ATEC symptom scores, the reported data shows the cord blood group started with an average score of around 14 and, across several time points, scores were reported as approximately 11, 7, 11, 12, and 11. The standard therapy group's scores across the same time points were reported as approximately 14, 14, 16, 14, 15, and 11. The reported data also includes some blood test measurements — such as immune cell counts and levels of certain proteins called cytokines — taken only in the cord blood group, though the clinical significance of those numbers is not described in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02008396 · results posted 14 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02008396) looked at whether MDMA-assisted therapy might reduce symptoms of Social Anxiety Disorder. A total of 12 people took part, split into three groups of four: one group received an inactive placebo alongside psychotherapy, one received MDMA at doses of 75mg and 100mg alongside therapy, and one received MDMA at doses of 100mg and 125mg alongside therapy. The main thing being measured was social anxiety symptoms, using a structured questionnaire called the Liebowitz Social Anxiety Scale (LSAS) — a scoring tool where higher numbers mean more severe anxiety, on a scale from 0 to 144. The reported data shows that, roughly one month after the second therapy session, the LSAS scores were: 34.3 for the 75mg/100mg MDMA group, 55.5 for the 100mg/125mg MDMA group, and 64.0 for the placebo group. To put those numbers in context, the scale's own categories describe scores of 55–65 as indicating "moderate" anxiety symptoms and scores above 65 as "marked" or higher. The reported data also shows how much each group's score changed from the start of the trial: the 75mg/100mg MDMA group's score dropped by an average of 51.0 points, the 100mg/125mg MDMA group's score dropped by an average of 39.0 points, and the placebo group's score dropped by an average of 19.3 points. It is worth noting that this was a very small trial with only four people per group, so these figures should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02088047 · results posted 9 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02088047) set out to measure self-stimulating behaviours in children, comparing two groups: one using a device or approach called "Profoveate" and one called "NonProFoveate." A very small number of people took part — only 4 participants were enrolled in total, and only 3 completed the study. The trial was terminated early because not enough people signed up to take part. The reported data shows that the primary outcome being tracked was the number of self-stimulating behaviours observed. For the Profoveate group, 40 such behaviours were recorded, while the NonProFoveate group recorded 27. Because the study ended with so few participants, the results are based on a very small sample — 3 people across both groups combined — and no additional secondary outcome data appears to have been reported. It is worth noting that the trial itself acknowledged these limitations, stating in the results that only 3 participants completed the study and that it was stopped due to low enrolment. No further breakdown or additional measures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02504554 · results posted 18 December 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 18 children in total — 12 in an oral group and 6 in a rectal group — and all 18 completed the study with no dropouts. The trial was measuring a range of things in children with autism, including gut (gastrointestinal) symptoms, autism-related behaviours as rated by parents, social skills, and certain blood test markers. Because the results were reported combining both groups together, the figures below reflect all participants as one combined group. The reported data shows the following numbers across the scales used. For gut symptoms (scored 1–7, where higher means worse), the average score was reported as 2.74 at the start and 1.31 at a later point. For autism symptoms as rated by parents on the PGI-R scale (ranging from -3 meaning much worse to +3 meaning much better), the reported average change was 1.4. On the Childhood Autism Rating Scale (scored 15–60, higher meaning greater severity), scores were reported as 39.7 at one point and 34.1 at another. On the Social Responsiveness Scale (scored 0–195, higher meaning greater severity), scores were reported as 116.2 and then 97.8. For blood safety markers, the reported data shows that 0 out of 18 participants had a clinically significant change in their blood test results. One scale — the Short Sensory Profile — was not completed due to an administrative error, so no data was reported for that measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02278328 · results posted 21 October 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02278328) enrolled 25 people across three groups, with 21 completing all stages after some participants did not pass an initial screening step. The trial used a "crossover" design — meaning every participant tried all three conditions at different times: a placebo (inactive treatment), a 15 mg dose, and a 30 mg dose, with a one-week break between each. The study was measuring specific brain activity signals, recorded using specialised brain-scanning equipment, to see how those signals varied under each condition. In particular, it looked at the timing and consistency of the brain's response to sounds, as well as a brain chemical called GABA, in both the left and right sides of the brain. The reported data shows the following measurements across the three conditions (placebo, 15 mg, and 30 mg respectively). For the timing of a particular brain signal in the left side of the brain, the recorded figures were 90.9, 87.4, and 89.3 milliseconds (thousandths of a second). For the same signal on the right side, the figures were 95.1, 87.8, and 93.8 milliseconds. For a measure of how consistently the brain responded to a repeated sound (described as "inter trial coherence" — essentially a score of how reliably the brain's response repeated itself, on a scale where higher means more consistent) in the left brain, the figures were 0.253, 0.239, and 0.244; and in the right brain, 0.324, 0.325, and 0.306. Finally, for a measure of the brain chemical GABA in the left side of the brain, the reported ratios were 0.155, 0.154, and 0.164. No corresponding GABA data for the right hemisphere was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02939560 · results posted 1 October 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at a brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS) — a non-invasive procedure that uses magnetic pulses directed at the brain. Thirteen people started the trial and ten completed it, with three not finishing. The study tracked several things using standard rating scales, including depression symptoms, behaviour, social responsiveness, autism-related symptoms, and repetitive behaviours. There was also a brain scanning component (functional MRI) intended to look at brain activity during thinking tasks. The reported data shows the following score changes across the rating scales used. For depression (measured on a scale of 0–53, where higher means more severe), scores were recorded at around 21.5 at the start and 10.2 at a later point. For the behaviour checklist (scale 0–174), scores of 53, 24, 20, and 30 were reported across different time points. For social responsiveness (scale 0–195), the reported figures were 70.5, 70.1, 66.0, and 66.9. For the autism-related symptom scale (scale 0–240), scores of 38, 38, 39, and 39 were reported. For the repetitive behaviour scale (scale 0–100), figures of 59, 26, 27, and 30 were recorded. It is worth noting that the data submission does not clearly label which measurements correspond to which time points (for example, "before" versus "after" treatment), so the reported numbers should be interpreted with that limitation in mind. For the brain scanning outcome, no numerical results were reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01972074 · results posted 11 September 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01972074) enrolled 61 people across three groups: 22 received memantine, 21 received a placebo (a dummy treatment with no active ingredient), and 18 were in a control group. The trial was measuring whether memantine had an impact on autism spectrum disorder (ASD) symptoms in children, using two tools: a parent-completed questionnaire called the Social Responsiveness Scale (SRS-2), which rates the severity of ASD-related behaviours, and a clinician's rating of overall symptom improvement called the ASD CGI-I. Not everyone finished the study — 16 of the 22 in the memantine group, 17 of the 21 in the placebo group, and 15 of the 18 in the control group completed it. The reported data shows that the primary outcome focused on counting "treatment responders" — defined as participants whose parent-reported SRS-2 score dropped by at least 25% from the start of the trial to the end, and who also received a clinician improvement rating of 2 or lower (meaning "much improved" or "very much improved"). According to the results reported on ClinicalTrials.gov, 9 out of 22 participants in the memantine group met this definition of a treatment responder, compared with 4 out of 21 participants in the placebo group. No outcome data was reported for the control group in this measure. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02508259 · results posted 16 July 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02508259) involved 10 boys with autism spectrum disorder — 5 received a single intravenous (drip) dose of a drug called suramin, and 5 received a saltwater placebo (an inactive substitute). All 10 participants completed the study. The trial was measuring changes in a range of autism-related behaviours and language skills over 6 weeks, using several standardised rating scales completed by clinicians and parents. The reported data shows the following changes from before treatment to 6 weeks after, expressed as average score differences within each group. On the ADOS-2 (a clinician-rated scale of autism symptoms, scored 0–10, where higher means more severe), the suramin group showed an average change of −1.6 points, while the placebo group showed −0.4 points. On the expressive language test (where higher scores mean better language ability), the suramin group showed an average change of −4.2 points and the placebo group +2.0 points. For the secondary measures: on the repetitive behaviour questionnaire (0–87, higher is worse), the suramin group changed by −3.2 and the placebo group by −0.8; on the parent-rated stereotypy (repetitive movements) scale (0–21, higher is worse), the suramin group changed by −4.0 and the placebo group by +1.0; on the autism language disability sub-score (0–20, higher is worse), the suramin group changed by −2.0 and the placebo group by −0.2; and on the clinician's overall impression of change scale (1–7, where 1 is much improved and 4 is unchanged), the suramin group changed by −1.8 and the placebo group by 0.0. It is important to note that this was a very small pilot trial with only 5 participants in each group, which means these reported numbers should be interpreted with considerable caution. The reported data shows the measurements recorded during this study, but a trial of this size is generally considered too small to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02088905 · results posted 1 March 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 23 families in total — 13 were assigned to receive Parent Child Interaction Therapy (PCIT) and 10 were placed on a waiting list as a comparison group. The children in the study had autism spectrum disorder, and the trial was measuring things like the frequency of challenging behaviours, parenting stress, social skills, and how parents and children interacted during play. By the end of the study, 8 families in the PCIT group and 9 in the waitlist group had completed all assessments. The reported data shows scores from several questionnaires at two time points (around week 9 and week 18). On the main measure of child behaviour (the Eyberg Child Behavior Inventory, scored 36–252 for frequency, with higher numbers meaning more frequent challenging behaviours), the PCIT group scored 132.5 at week 9 and 115.2 at week 18, while the waitlist group scored 154.3 at week 9 and 148.7 at week 18. A separate part of the same questionnaire asked whether behaviours were considered a problem (scored 0–36); the PCIT group scored 18.9 at week 9 and 14.1 at week 18, compared with 19.1 and 19.7 for the waitlist group. On the parenting stress measure (scored 43–215 overall, with higher meaning more stress), total stress scores were 96.1 for the PCIT group and 104.6 for the waitlist group. On the social skills measure (scored 0–195, higher meaning more difficulty), the PCIT group scored 91.2 at the first time point and 80.0 at the second, while the waitlist group scored 92.2 and 88.2 respectively. The reported data also shows an observation-based measure of how parents interacted with their child during play: the PCIT group recorded an average of 35.2 positive interaction behaviours and 26.9 negative interaction behaviours, compared with 81.8 positive and 5.7 negative for the waitlist group — though it is worth noting these numbers were not explained further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02361762 · results posted 20 February 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 70 children split into two groups of 35 — a "Training" group and a "Waitlist" group. By the end of the study, 35 children in the Training group and 33 in the Waitlist group completed the trial (2 in the Waitlist group did not finish). The trial was measuring several aspects of brain-based self-control skills — sometimes called executive function — including how quickly children could stop a response when asked to, how well they handled conflicting information, brain activity patterns recorded during tasks, and how parents rated their children's everyday self-control at home and school. The reported data shows the following numbers after the study period, with each group's score listed in turn (Training group first, Waitlist group second). For the stop-signal task (where lower numbers mean faster stopping), scores were 213.6 milliseconds versus 234.7 milliseconds. For the Stroop colour-word task measuring how much conflicting information affected accuracy (where lower differences are better), scores were 2.9 versus 3.8. For the brain-activity measure recorded during a similar task, multiple sets of numbers were reported across different conditions, ranging from −0.20 to −1.8 microvolts in the Training group and −2.5 to −3.8 microvolts in the Waitlist group. For the parent-rated self-control survey (where lower scores indicate fewer reported difficulties), scores were 65.85 versus 67.77. For the two secondary measures — a memory task and a social problem-solving task — the reported scores were close between groups, at 10.15 versus 9.55 and 32.9 versus 31.0 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01624194 · results posted 6 June 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 34 children or young people altogether — 16 in the oxytocin nasal spray group and 18 in the placebo (dummy spray) group. The trial was measuring whether oxytocin nasal spray had any effect on social abilities in participants, using a parent-rated questionnaire called the Social Responsiveness Scale (SRS), where a lower score means better social abilities. Several other things were also tracked, including behaviour, anxiety, and any side effects reported by parents over a four-week treatment period. The reported data shows that, on the primary measure — change in SRS scores from the start of the trial to the end — the oxytocin group showed an average change of 9.73 units, while the placebo group showed an average change of 3.18 units (both in the direction of lower, or better, scores). For the clinical impression rating at week 4, no participants in either group were rated "Very Much Improved"; 3 in the oxytocin group and 3 in the placebo group were rated "Much Improved"; 2 in the oxytocin group and 5 in the placebo group were rated "Minimally Improved"; and 9 in the oxytocin group and 10 in the placebo group were rated "No Change." On the anxiety scale, the oxytocin group showed an average change of 1.66 units and the placebo group 4.53 units. Side effect counts reported by parents were low and similar across both groups, with only small numbers of participants in either group recorded as experiencing any particular symptom. The reported data also shows various behaviour scores (such as irritability and hyperactivity) at the start and end of the study, with both groups showing some shifts in scores over the four weeks. It is worth noting that only 14 of the 16 participants in the oxytocin group completed the trial, while all 18 in the placebo group completed it; the reasons for the two non-completions were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02383758 · results posted 11 January 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants in total, split evenly into two groups of 10 — one group received the treatment program, and the other was placed on a waitlist as a control group. All 10 participants in the treatment group completed the study, while 8 out of 10 in the waitlist group completed it (2 did not finish). The trial was measuring bowel control in people with encopresis (a condition where stool passes unintentionally), looking at things like how often bowel movements were "continent" (meaning the person had control over them) and how often they happened without the need for any medications. The reported data shows that at the end of the study period, 5% of participants in the treatment group were recorded as having continent bowel movements, compared with 0% in the waitlist group. For independent bowel movements (continent and without medication), the reported figure was also 5% for the treatment group and 0% for the waitlist group. The reported data also shows scores from a 7-point severity rating scale (where 1 means no illness and 7 means extremely ill): the treatment group's average score moved from 5.4 at the start to 4.3 by the end, while the waitlist group went from 5.2 to 4.9. On a separate 7-point improvement scale (where 1 means very much improved and 7 means very much worse), the treatment group's average score was reported as 2.1 at the later time point, compared with 3.6 for the waitlist group. It is worth noting that these are small numbers — only 10 people per group — so the reported percentages reflect just one or two individuals rather than large proportions of a population. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02739321 · results posted 6 November 2017

  According to the results reported on ClinicalTrials.gov, a total of 45 people took part in this trial — 23 in one group and 22 in the other. The study looked at a mattress technology and used a crossover design, meaning participants spent time sleeping both with the technology switched on and with it switched off. The trial was measuring things like how many people dropped out, how long they slept, how long it took them to fall asleep, and how parents rated their child's sleep quality on a scale. The reported data shows that only 1 participant dropped out from each group due to issues with the mattress technology itself, against a comparison rate of 30% that the researchers had used as a reference point. For the secondary measures — which compared the "technology on" periods against the "technology off" periods across all participants — the reported average parent-rated sleep quality score (on a 1-to-7 scale, where 7 is "exceptional") was 4.9 with the technology on and 4.3 with it off. The reported average total time asleep was 8.35 hours with the technology on and 7.99 hours with it off. The average time it took participants to fall asleep was reported as 14.11 minutes with the technology on and 18.20 minutes with it off. Time spent awake during the night was reported as 17.85 minutes with the technology on and 18.79 minutes with it off. Finally, the percentage of time in bed actually spent sleeping (sometimes called "sleep efficiency") was reported as 78.27% with the technology on and 75.45% with it off. It is worth noting that 7 participants did not complete the study in total (3 from one group, 4 from the other), and the data as submitted does not provide further explanation of whether those non-completions affected these results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01617460 · results posted 20 October 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01617460) involved 86 people who were given aripiprazole. Of those who started, 46 completed the study and 40 did not finish. The trial was looking at changes in irritability-related behaviours, measured using a tool called the Aberrant Behavior Checklist – Japanese Version (ABC-J). This checklist has a section focused on irritability, made up of 15 questions, where each question is scored from 0 (no problem) to 3 (severe problem), giving a total possible score of 0 to 45. A higher score on this scale means more severe behavioural concerns. The reported data shows that, on average, participants' irritability subscale scores changed by −3.2 points from the start of the study to the final assessment. A negative number here means the average score went down (i.e., lower on the scale) compared to where it started. No other outcome measure results were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01887132 · results posted 25 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants, all of whom completed the study. All 4 were in a single group that received an open-label course of donepezil (meaning everyone knew what treatment was being given — there was no comparison or placebo group). The trial was measuring two main things: a score called the Nonverbal Developmental Quotient (NVDQ), which is a way of estimating non-verbal thinking ability relative to a child's age (where 100 is considered average, and below 70 is considered in the impaired range); and the percentage of sleep time spent in REM sleep (the active dreaming stage of sleep). The reported data shows that NVDQ scores across the 4 participants, measured at different time points, ranged from approximately 44.7 to 59.0. All of these figures fall well below the average score of 100, and below the 70 mark that the researchers described as the impaired range. For the secondary measure, the reported data shows that the percentage of sleep spent in REM ranged from about 8.5% to 27.5% across participants and time points. Several other planned measurements — including autism assessment scores, a parent questionnaire, and further sleep quality analyses — were listed in the trial but no numerical results were reported for those outcomes in the data submitted to ClinicalTrials.gov. It is worth noting that with only 4 participants and no comparison group, the reported numbers represent a very small snapshot. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01474746 · results posted 25 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 57 children in total — 30 in the placebo group and 27 in the active treatment group. Most children completed the study (27 in the placebo group and 25 in the active group). The trial was measuring changes in language development and overall behaviour over six months in children with autism spectrum disorder, using a range of standardised tests and caregiver ratings. The reported data shows the following numbers for the main (primary) outcomes. On the Mullen Scales of Early Learning expressive language raw score (a 0–50 scale where higher means stronger language ability), the placebo group started at an average of 19.3 and reached 21.3 at six months, while the active group started at 21.3 and reached 25.04. On the same test but using a different scoring method called a T score (a standardised scale where 50 is average for the general population), the placebo group went from 23.3 down slightly to 22.6, while the active group stayed at 25.8 at both time points. For the overall behaviour rating (Clinical Global Impression – Improvement, a 1–7 scale where lower means more improvement as rated by the caregiver), the placebo group averaged 2.59 and the active group averaged 2.28 at the six-month visit. For the secondary outcomes, the autism symptom assessment (ADOS-2, scored 0–28 with higher scores indicating more symptoms) showed averages of 10.73 for the placebo group and 11.00 for the active group at follow-up. The caregiver-rated behaviour scale and an eye-tracking measure were also reported at baseline, but the data as submitted does not include follow-up change figures for those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01078844 · results posted 26 July 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 4 participants in total, all placed into a single group. The study was measuring changes in symptom severity using a tool called the Clinical Global Impression Scale (CGI-S), which is a standardised rating used by clinicians to assess how unwell a person appears overall. The trial also included a comparison between a placebo (an inactive treatment) and memantine (the study drug). The reported data shows that none of the 4 participants completed the trial — all 4 withdrew or did not finish for reasons that were not detailed in the submitted results. Because no participants completed the study, no outcome measurements were recorded or submitted for the primary measure. In other words, the data was not reported for the CGI-S results, so it is not possible to describe what the numbers showed. Given that the trial ended without any participants completing it, the submitted records do not contain figures that would allow any conclusions to be drawn about what was being studied. The reported data shows only that the study started and that participation did not continue through to completion for any of the four people involved. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00549562 · results posted 16 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom received a medication called paliperidone ER (an extended-release tablet). Twenty-three of the 25 participants completed the study, while two did not finish. The trial was measuring behaviours and social functioning in children and adolescents with a pervasive developmental disorder (a category that includes conditions like autism), using a number of standard rating scales filled out by clinicians, parents, and teachers. The reported data shows the following scores at the end of the study period. On the main (primary) outcome, the Clinical Global Impression-Improvement scale — where a clinician rates overall change on a 1-to-7 scale, with 1 meaning "very much improved" and 7 meaning "very much worse" — the average reported score was 1.8. On the other primary measure, the Aberrant Behavior Checklist, which looks at difficult behaviours across five areas, the reported average scores were: Irritability 12.6 (out of a possible 45), Hyperactivity 17.4 (out of 48), Social Withdrawal 7.6 (out of 48), Stereotyped movements 6.4 (out of 21), and Inappropriate Speech 3.4 (out of 12). For the secondary measures, the reported average score for repetitive behaviours was 11.9 out of 20; for social functioning, 100.9 out of a possible maximum that would indicate severe impairment (scores above 87 were considered in the severe range on this scale); and for unwanted behaviours, scores of 19.0, 6.4, and 25.1 on the three parts of that scale were reported. No comparison group was included in this trial, so these numbers reflect the one group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01086475 · results posted 14 April 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 67 children or adults — 34 in the D-cycloserine group and 33 in the placebo (dummy treatment) group. All participants completed the study with no dropouts recorded. The trial was measuring changes in social behaviour associated with autism, using two main tools: the Social Responsiveness Scale (SRS), a 65-item questionnaire where higher scores indicate greater levels of difficulty, and the Clinical Global Impressions Improvement Scale (CGI-I), where a clinician rates overall change on a 1–7 scale (1 being most improved, 7 being most worsened). The reported data shows that, looking at the change in SRS scores over the course of the trial, the D-cycloserine group's scores dropped by an average of 13.39 points, while the placebo group's scores dropped by an average of 17.00 points. At a follow-up assessment, the reported average SRS scores were 83.5 for the D-cycloserine group and 89.2 for the placebo group — both figures falling in what the scale describes as the "moderate range of impairment" (scores between 80 and 108). For the secondary measure, the reported data shows that 32.3% of participants in the D-cycloserine group were rated as "much" or "very much improved" by their clinician at week 11, compared with 33.3% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01911442 · results posted 25 February 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01911442) enrolled 150 children and adolescents across three groups: 49 received lurasidone at a dose of 20 mg once daily, 51 received lurasidone at 60 mg once daily, and 50 received a placebo (a dummy treatment with no active ingredient). The trial ran for 6 weeks and was primarily measuring changes in irritability — a behaviour commonly assessed in young people with autism spectrum disorder — using a standardised questionnaire called the Aberrant Behavior Checklist (ABC) Irritability Subscale, which scores from 0 (no problems) to 45 (most severe). The reported data shows that on the primary measure — change in ABC Irritability Subscale score at week 6 — the 20 mg lurasidone group showed a change of −8.8 points, the 60 mg group showed a change of −9.4 points, and the placebo group showed a change of −7.5 points (where a negative number means scores went down from the start of the trial). For the secondary measures, the reported data shows changes in overall illness severity (CGI-S) of −1.1, −1.0, and −0.7 for the 20 mg, 60 mg, and placebo groups respectively. On the hyperactivity subscale, changes were −9.7, −6.6, and −7.1. On a measure of repetitive behaviours (CY-BOCS), all three groups showed a change of around −1.0 to −1.2 points. For caregiver strain, changes were −1.49, −1.66, and −1.35. When looking at the proportion of participants rated as "very much improved" or "much improved" by a clinician at week 6, the reported figures were 17% in the 20 mg group, 17% in the 60 mg group, and 14% in the placebo group. It is worth noting that all three groups — including the placebo group — showed reductions across most of the measures reported, and the number of participants who did not complete the trial was higher in the placebo group (12 out of 50) than in either lurasidone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00409747 · results posted 11 December 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 11 people who received the antibiotic minocycline. Ten participants completed the study, and one did not finish. The trial was measuring changes in levels of certain proteins and chemical messengers found in the blood and spinal fluid (the fluid surrounding the brain and spine) before and after treatment. It also looked at how clinicians rated the overall severity of each participant's condition using a standard rating tool. The reported data shows that the researchers used a statistical method (called the Mann-Whitney U-test) to compare protein levels before and after treatment. This method produces a number called a "z-score" — a negative z-score means the measured level went down from before to after treatment. The reported z-scores for the 11 proteins tested in spinal fluid ranged from −0.18 to −2.19, all in the negative direction, meaning levels of all these proteins appeared lower after treatment compared to before. The protein called HGF showed the largest reported decrease (z-score of −2.19), while a protein called CCL3 showed the smallest reported change (z-score of −0.18). For the clinical severity rating scale — where 1 means not at all ill and 7 means extremely ill — the reported data shows an average score of 4.4 before treatment and 4.6 after treatment. No further breakdown of these scores was reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01592773 · results posted 16 February 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 747 people, all of whom received a medicine called memantine. The trial was a single-group study — meaning everyone received the same treatment with no comparison group — and it was set up to track any unwanted or unexpected health events (called "treatment-emergent adverse events") that occurred while participants were taking the medicine. Of the 747 people who started the trial, 81 completed it, while 666 did not complete it; the reasons for not completing were not detailed in the data provided here. The reported data shows that the primary thing being measured was how many participants experienced at least one treatment-emergent adverse event — that is, any health issue that appeared or worsened after starting the medicine. According to the results reported on ClinicalTrials.gov, 424 out of 747 participants had at least one such event recorded. No further breakdown of what those events were, or how serious they were, was included in the data submitted. No other outcome measures were reported in the structured results data available. It is also worth noting that because such a large number of participants (666 out of 747) did not complete the trial, the reported data should be understood in that context — though no explanation for this was provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01322022 · results posted 2 February 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 40 children with sleep difficulties, with their parents split into two groups of 20 — one group received **Parent Training** and the other received **Parent Education**. The trial measured children's sleep patterns at the start of the study (baseline) and again at weeks 4 and 8. By the end of the study, 15 of the 20 parents in the Training group and 18 of the 20 in the Education group had completed the trial. The reported data shows three main sleep measures. The first was a questionnaire-based score (ranging from 0–12, where higher means more troubled sleep): the Parent Training group started at 6.53, dropping to 4.80 at week 4 and 4.47 at week 8; the Parent Education group started at 7.44, dropping to 6.83 at week 4 and 6.28 at week 8. The second measure was sleep efficiency — the proportion of time in bed actually spent sleeping: the Parent Training group went from 82% at baseline to 86% at week 4 and 85% at week 8, while the Parent Education group went from 85% to 86% and stayed at 86%. The third primary measure was how long it took children to fall asleep after lights out: the Parent Training group recorded 35 minutes at baseline, 36 minutes at week 4, and 33 minutes at week 8; the Parent Education group recorded 29 minutes, 27 minutes, and 29 minutes at the same time points. A secondary measure — total time spent asleep — was also recorded using a wrist movement device: the Parent Training group recorded 455, 444, and 460 minutes across the three time points, while the Parent Education group recorded 448, 439, and 434 minutes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02004236 · results posted 16 October 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 225 children aged 5 to 12 years who had been diagnosed with Autism Spectrum Disorder (ASD). They were divided into three groups of 75: one group received a type of mild electrical brain stimulation (called tRNS) applied over one region of the brain, a second group received it over a different brain region, and a third group received a sham (inactive/pretend) version of the stimulation. All children also took part in intensive speech therapy during the sessions over three months. The trial was measuring two main things: verbal fluency (how many words children could name in a category within 60 seconds) and sociability (rated using a standardised autism behaviour scale called CARS, where lower scores indicate less severe autism-related behaviours). It also measured brain activity patterns using brainwave recordings before and after treatment. Sixteen participants in the sham group did not complete the study; the data does not report the reasons why. The reported data shows that for verbal fluency, scores before treatment were similar across all three groups (around 9.3 to 10.5 words on average). After treatment, the reported scores were similar again — around 8.3 to 10.4 — with no large differences between the groups visible in the numbers provided. For the sociability (CARS) scale — where scores below 30 are classified as "not autistic," 30–36.5 as "moderately autistic," and above 36.5 as "severely autistic" — all three groups started with average scores in the moderate range (30.6, 32.1, and 31.8). After treatment, the reported data shows the two active stimulation groups recorded average scores of 19.4 and 20.2 (falling below the 30 threshold), while the sham group's average score remained at 30.1. Regarding the brainwave measurements, the reported data shows that before treatment, the ratio of theta to beta brainwave activity (a measure of certain brain signal patterns) was 25, 30, and 26 across the three groups. After treatment, those figures were reported as 12, 14, and 25 respectively for the two active and one sham group. Similar patterns were noted in a separate measure of brainwave signal strength. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01592786 · results posted 7 August 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01592786) involved 903 participants who were given memantine hydrochloride (also known as memantine HCl). The trial was a single-group study, meaning everyone received the same treatment — there was no comparison or placebo group. Of the 903 people who started, 765 completed the study and 138 did not finish. The main thing the trial was measuring was how many participants showed a meaningful improvement on a scale called the Social Responsiveness Scale (SRS), which is a 65-item caregiver-rated questionnaire that measures social behaviour and characteristics associated with autism. Scores on this scale range from 0 to 195, with higher scores indicating greater difficulty with social interaction. The reported data shows that, to count as a "confirmed responder" on the SRS, a participant needed to have taken the medication for at least 12 weeks and to have shown a drop of 10 or more points on their SRS total score at two separate check-ins at least two weeks apart. According to the results reported on ClinicalTrials.gov, out of 903 participants who started the study, 517 met the criteria to be considered a confirmed responder. The data also lists a second figure of 351 participants in the same outcome measure, however the reporting does not clearly explain what this second number refers to, so it would not be appropriate to describe it further. It is worth noting that because this trial had only one group and no comparison group, the numbers describe what was observed in participants taking memantine HCl, but do not on their own show whether outcomes would have been different without the medication. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00850070 · results posted 28 February 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 46 children in total — 23 received sapropterin (also known as BH4) and 23 received a placebo (a dummy treatment with no active ingredient). The trial was looking at children with autism spectrum disorder (ASD) and measuring things like overall clinical impression, language skills, and everyday adaptive behaviours over a period of 16 weeks. Of those who started, 20 in the sapropterin group and 22 in the placebo group completed the study. The reported data shows that for the two main outcome measures — clinician ratings of improvement and severity — 5 out of 23 participants in the sapropterin group were rated as "much or very much improved" on the improvement scale, compared with 3 out of 23 in the placebo group. On the severity scale, 3 participants in the sapropterin group showed improved severity ratings, compared with 1 in the placebo group. For language skills (measured using a standard assessment tool where higher raw scores indicate better ability), the sapropterin group had an average raw score of 84 at the end of the study, while the placebo group recorded 60. For everyday adaptive behaviours (daily living, communication, socialisation, and motor skills combined), the sapropterin group averaged a raw score of 344.76, compared with 294.9 in the placebo group. It is worth noting that two secondary outcome measures — the obsessive-compulsive symptom scale and the ADHD questionnaire — had no results reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00541346 · results posted 6 February 2014

  According to the results reported on ClinicalTrials.gov, this trial involved 16 participants, all of whom received a methylphenidate skin patch (a patch worn on the skin that delivers medication). All 16 completed the starting phase, and 15 of the 16 completed the full eight-week follow-up period. The trial was measuring changes in ADHD-related behaviours and a range of other behaviours — including hyperactivity, irritability, social withdrawal, repetitive behaviours, and inappropriate speech — using standardised rating scales scored by parents or clinicians. The reported data shows that on the main measure, an ADHD symptom rating scale scored from 0 to 54 (where higher numbers mean more frequent symptoms), participants had an average score of 39.9 at the start of the trial and 13.8 at the eight-week follow-up visit. For the secondary behaviour measures, the reported data shows average scores also appeared lower at the follow-up point compared to the start across all five areas: hyperactivity (34.1 down to 11.3, out of a possible 48), irritability (19.8 down to 9.1, out of 45), social withdrawal (11.3 down to 4.5, out of 48), repetitive behaviours (5.6 down to 1.3, out of 21), and inappropriate speech (5.5 down to 2.1, out of 12). It should be noted that the data as submitted does not include a comparison or control group, so these before-and-after numbers represent one group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00786799 · results posted 31 August 2012

  According to the results reported on ClinicalTrials.gov, this trial looked at whether omega-3 fatty acids (fish oil-type supplements) had any effect on hyperactivity symptoms in children with autism. A total of 27 children took part — 14 were given omega-3 fatty acids and 13 received a placebo (a dummy treatment with no active ingredient). Most children completed the study: 13 in the omega-3 group and 12 in the placebo group finished, with one child dropping out from each group. The primary thing being measured was change in hyperactivity scores using a tool called the Aberrant Behavior Checklist – Hyperactivity subscale, which is rated by a parent or caregiver. Scores on this scale run from 0 (no problems) to 45 (severe problems), and a drop in score would indicate improvement. The reported data shows that the omega-3 group's scores changed by an average of 2.7 points, while the placebo group's scores changed by an average of 0.3 points. The reported comparison between the two groups showed a difference of 2.3 points. The reported data also shows changes in two other measures: blood levels of omega-3 fatty acids increased by about 2.54% on average in the omega-3 group and decreased slightly (–0.10%) in the placebo group. A substance in the blood called TNFα (a marker linked to inflammation) changed by an average of 1.3 units in the omega-3 group and –0.9 units in the placebo group, though no further detail about what these changes mean clinically was reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00584701 · results posted 24 July 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 49 participants, all of whom received risperidone (a medication). The trial had a single group — there was no comparison or placebo group. The study was measuring changes in irritability symptoms in children with autism, using a standard caregiver-completed questionnaire called the Aberrant Behavior Checklist – Irritability subscale (ABC-I). This questionnaire scores symptoms from 0 (no problems) to 45 (major problems), with a lower score meaning fewer reported symptoms. The trial also looked at whether certain gene activity patterns in the blood were linked to how much participants' scores changed. The reported data shows that, among participants who completed the 8-week treatment period, the average ABC-I score decreased by approximately 44.5% compared to where it started (called "baseline"). Because a lower score on this scale reflects fewer reported symptoms of irritability, a negative percentage change means scores went down on average. For the genetic part of the study, the reported data shows that 5 genes were identified whose activity levels appeared to be linked — either rising or falling — alongside changes in participants' ABC-I scores. No further detail about which genes or the strength of those links was included in the submitted results data. It is worth noting that 3 of the 49 participants did not complete the treatment period, and a further 12 did not complete the follow-up phase, so the numbers above reflect only those who remained in the study at each stage. Because this trial had only one group and no comparison group, the reported figures describe what was measured in that group alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.