Autism Spectrum Disorder Trial, Recruiting (NCT06523387)

Autism Spectrum Disorder Trial, Recruiting NCT06523387 Sponsor: Stanford University Condition: Autism Spectrum Disorder

Printed from Voxsanity (voxsanity.com.au) — NCT06523387 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Autism Spectrum Disorder

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:

Children who are between 2 years 0 months and 5 years 11 months old at the time of joining the study
Children who have been diagnosed with Autism Spectrum Disorder (ASD), or are suspected of having ASD, confirmed through a specific structured assessment called the ADI-R
Children who have significant difficulties with communication skills, measured as being well below average on standardised communication tests (the specific level required depends on the child's age — confirm exact thresholds with the trial site)
Children whose communication difficulties are rated at least "moderately severe" on a standard clinical rating scale
Families where an English-speaking parent or caregiver is able to consistently take part in the study activities and carry out the treatment approach in English
Children whose psychiatric medications or other biomedical treatments have been stable for at least 1 month before the start of the study, with no changes expected during participation
Children whose other therapies (such as ABA, Floortime, speech therapy) and school placement have been stable for at least 1 month before the start of the study, with no changes expected during participation
Children who are currently receiving no more than 60 minutes of one-on-one speech therapy per week

Who may not be able to join:

Children whose primary language at home is not English
Children or parents who have a severe psychiatric disorder, or either party has an unstable medical condition
Children whose parent has already completed a full course of Pivotal Response Treatment (a specific therapy approach) and demonstrated a high level of skill in delivering it
Children who are currently receiving more than 15 hours per week of one-on-one ABA (Applied Behaviour Analysis) therapy at home
Families who live within 100 miles of Stanford University

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 28 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: Grace Gengoux, PhD, Stanford University

Phone: (650) 736-1235

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06523387

Sponsor: Stanford University

Phase: Not Applicable

Status: Recruiting

Condition: Autism Spectrum Disorder

Trial contact: (650) 736-1235

More information: https://clinicaltrials.gov/study/NCT06523387

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Children who are between 2 years 0 months and 5 years 11 months old at the time of joining the study
Children who have been diagnosed with Autism Spectrum Disorder (ASD), or are suspected of having ASD, confirmed through a specific structured assessment called the ADI-R
Children who have significant difficulties with communication skills, measured as being well below average on standardised communication tests (the specific level required depends on the child's age — confirm exact thresholds with the trial site)
Children whose communication difficulties are rated at least "moderately severe" on a standard clinical rating scale
Families where an English-speaking parent or caregiver is able to consistently take part in the study activities and carry out the treatment approach in English
Children whose psychiatric medications or other biomedical treatments have been stable for at least 1 month before the start of the study, with no changes expected during participation
Children whose other therapies (such as ABA, Floortime, speech therapy) and school placement have been stable for at least 1 month before the start of the study, with no changes expected during participation
Children who are currently receiving no more than 60 minutes of one-on-one speech therapy per week

Who may not be able to join:

Children whose primary language at home is not English
Children or parents who have a severe psychiatric disorder, or either party has an unstable medical condition
Children whose parent has already completed a full course of Pivotal Response Treatment (a specific therapy approach) and demonstrated a high level of skill in delivering it
Children who are currently receiving more than 15 hours per week of one-on-one ABA (Applied Behaviour Analysis) therapy at home
Families who live within 100 miles of Stanford University

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Stanford University

Registry

ClinicalTrials.gov

Start date

30 January 2026

Est. completion

30 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline on Parent Fidelity of Pivotal Response Treatment Implementation as measured on the Home Video Observation (HVO); Change from Baseline on Child Functional Verbal Utterances as measures on the Home Video Observation (HVO)

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: 28 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