RecruitingNot Applicable

PRT for Adolescents With High Functioning Autism

United States76 participantsStarted 2023-09-01

Plain-language summary

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical Diagnosis of Autism Spectrum Disorder, higher functioning/low support needs * Intelligence Quotient (IQ): Participants with a Full Scale IQ \> 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II) * Right-handed * No metal in their body/unremovable metal on their body (i.e., braces) * First language is English * Must live in the San Francisco Bay Area * Able and willing to receive intervention weekly for 9 weeks * Adolescent is interested in improving their social skills * MRI Compatibility: No major contraindication for MRI. * Diagnosis of ASD using ADOS-2 and ADI-R. * No evidence of a genetic, metabolic, or infectious etiology for their autism. * Primary diagnosis of ASD * No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period. * Stable treatment (e.g., ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation. * Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures) * No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period. Exclusion Criteria: * History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and/or gestational age \< 34 weeks * Left-handed * Braces or any me…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)

Timeframe: Pre-treatment baseline, and between 11 to 13 weeks post-baseline

Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions

Timeframe: Pre-treatment baseline, and between 11 to 13 weeks post-baseline

Trial details

NCT IDNCT05987761

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Autism trials

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)

Timeframe: Pre-treatment baseline, and between 11 to 13 weeks post-baseline

Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions

Timeframe: Pre-treatment baseline, and between 11 to 13 weeks post-baseline