Recruiting

PRT

Sponsor:

Stanford University

Code:

NCT05987761

Conditions

Autism

Autism Spectrum Disorder High-Functioning

Developmental Disability

Child Development

Behavior, Child

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

Interventions

PRT for Adolescents

Study Details

Brief 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).

Conditions

Autism

Autism Spectrum Disorder High-Functioning

Developmental Disability

Child Development

Behavior, Child

Study ID

NCT05987761

Start date

Sep 1, 2023

Status verified date

Mar, 2024

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Not accepted

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 metal in their body

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRT Treatment Group

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. Participants in the PRT Treatment Group will complete an 9-week intervention, PRT for Adolescents, to improve the adolescent's social skills. Following the completion of the 9-week intervention, participants will be asked to complete a second MRI brain imaging session, followed by post-measure appointments in order to assess immediate effects of the intervention.

experimental: Delayed Treatment Group

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. After 9-weeks without any intervention, participants in the Delayed Treatment Group will be asked to complete a second MRI brain imaging session, followed by post-measure appointments, and will then receive the PRT intervention at the end of the study.

Interventions

PRT for Adolescents

Clinician-led 70-minute PRT sessions targeting social skills once per week at Stanford.

Primary outcome measure

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

Central Contacts and Locations

Locations

Stanford Research Park

Recruiting

Palo Alto, California, United States, 94304

Contacts

Study Team

650-485-3149braindevelopment@stanford.edu

Lynn Koegel, Ph.D.

lynnk@stanford.edu

Principal Investigator:

Daniel A Abrams, Ph.D.

More Information

Sponsor

Stanford University

Last update posted

Mar 28, 2024

Last verified

Mar, 2024

Keywords

  • Autism
  • Autism Spectrum Disorder
  • PRT
  • Pivotal Response Treatment
  • Autism intervention
  • Social skills
  • Adolescents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2024-03-28.