Autism Spectrum Disorder Trial, Recruiting NCT04545606 Sponsor: University of Missouri-Columbia Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT04545606
Recruiting Not Applicable

Who may be able to join

AI generated eligibility 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

Who might be able to join this trial:

  • Your child is between 6 and 12 years old
  • Your child has a verbal IQ score of 70 or higher (confirm with trial site)
  • A parent or legal guardian who lives in the same home as the child must take part in the trial
  • The parent or guardian can read and understand English at around a 5th-grade level
  • Your child has been diagnosed with autism spectrum disorder (ASD) and has sleep problems (insomnia)
  • Your child's ASD diagnosis was made using official diagnostic tools and meets standard diagnostic guidelines (confirm with trial site)
  • Your child has had trouble falling asleep, staying asleep, or waking too early, as reported by the child or a parent, for 3 or more months
  • Your child has daytime problems because of poor sleep, such as mood, thinking, social, or school difficulties
  • Sleep tracking methods (sleep diaries and a wrist monitor) show that your child is losing more than 30 minutes of sleep on at least 6 nights due to sleep issues (confirm with trial site)

Who may not be able to join:

  • The parent is unable to give formal consent, or the child is unable to give their agreement to participate
  • The family is not willing to be randomly assigned to a treatment group
  • The child or parent is already taking part in another research study that randomly assigns treatments
  • The parent has a cognitive impairment that would prevent them from completing forms or carrying out the treatment steps
  • The child has an untreated medical condition, including other sleep disorders such as sleep apnea, epilepsy, psychotic disorders, thoughts of suicide, or frequent sleep disturbances like sleepwalking
  • The child is taking medications (other than stimulants, sleep medications, or melatonin) that affect sleep (confirm with trial site)
  • The child has taken stimulants, sleep medications (prescription or over-the-counter), or melatonin in the past month, unless they have been on a stable dose for 3 or more months
  • The child is currently receiving non-drug treatment for sleep problems outside of this trial, including talking therapies like CBT
  • The parent reports that the child would not be able to wear a heart monitor or wrist sleep tracker, for example due to extreme sensitivity or behavioral difficulties
  • There are other conditions that would interfere with taking part in the trial (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Christina S McCrae, PhD, University of Missouri-Columbia

Phone: 859-327-7762

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Missouri-Columbia
Registry
ClinicalTrials.gov
Start date
15 September 2020
Est. completion
1 August 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Baseline Average Objective Sleep Efficiency for the child; Change in Average Objective Sleep Efficiency for the child from baseline to immediately after the intervention; Change in Average Objective Sleep Efficiency for the child from baseline to 6 months; Change in Average Objective Sleep Efficiency for the child from baseline to 12 months; Baseline Average Bed/Waketime Variability for the child; Change in Average Bed/Waketime Variability for the child from baseline to immediately after the intervention; Change in Average Bed/Waketime Variability for the child from baseline to 6 months; Chang...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov