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Pivotal Response Treatment for Adolescents with High-Functioning Autism

This study is testing a behavioral therapy called Pivotal Response Treatment (PRT) for Adolescents. The goal is to see if PRT can improve social skills and behavior in highly verbal adolescents with autism spectrum disorder (ASD), and if it causes any changes in the brain. You may be able to join if you are 11 to 14 years old, have a clinical diagnosis of high-functioning ASD, an IQ over 80, and are right-handed. The study aims to enroll 76 participants, but its current recruitment status is unclear.

Study design
This is an interventional study that plans to enroll 76 participants. It is testing a behavioral therapy called PRT for Adolescents.
What's involved
Participants will attend clinician-led 70-minute PRT sessions once per week at Stanford. Brain connectivity and child-assessor interactions will be measured at the start and again between 11 to 13 weeks later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed between 11 to 13 weeks after starting the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05987761

PRT for Adolescents With High Functioning Autism

UNKNOWN
NAAges 11–14InterventionalTreatment
Stanford University
~76 participants
Updated 2024-03-28 on ClinicalTrials.gov
What's tested:PRT for Adolescents

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
(Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
Measured over Pre-treatment baseline, and between 11 to 13 weeks post-baseline
+1 more outcome measured

Conditions

Autism
Autism Spectrum Disorder High-Functioning
Developmental Disability
Child Development
Behavior, Child
Behavior, Social

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Autism Spectrum Disorder

NCT05987761

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford Research Park

    Palo Alto, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Dani A Abrams, Ph.D. · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Study Team
[email protected]
650-485-3149
Email the study team

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Eligibility criteria

Inclusion

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

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 metal in their body

What this trial measures

  • (Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)Pre-treatment baseline, and between 11 to 13 weeks post-baseline

    Target engagement consists of brain connectivity between voice selective superior temporal sulcus (STS) and the nucleus accumbens (NAc) of the mesolimbic reward system. For the PRT (i.e., intervention) group, brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model, a common measure of task-based brain connectivity using fMRI data. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and the NAc as the connectivity target region. Effect size will be computed using Cohen's d for a paired t-test comparing Post-Training and Pre-Training pSTS-NAc connectivity values (i.e., contrast betas): d = t/(sqrt(n) where t is the paired t-test and n the group size.

  • Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactionsPre-treatment baseline, and between 11 to 13 weeks post-baseline

    The Structured Laboratory Observations (SLO) of child-assessor interactions is a common behavioral measure of each participant's social communicative interactions assessed in a laboratory setting. The metric used to characterize the SLO is an overall percentage of appropriate social responsiveness. Change in baseline SLO will be computed by subtracting Post- from Pre-training percentage of appropriate social responsiveness for each participant in the PRT group.