PRT for Adolescents With High Functioning Autism

NCT ID: NCT05987761

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-08-31

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; Behavior, Social

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PRT for Adolescents

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

PRT for Adolescents

Intervention Type: BEHAVIORAL

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

Interventions

PRT for Adolescents

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Abrams

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dani A Abrams, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Research Park

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Study Team

Role: primary

braindevelopment@stanford.edu

650-485-3149

Lynn Koegel, Ph.D.

Role: backup

lynnk@stanford.edu

Other Identifiers

60502

Identifier Type: -

Identifier Source: org_study_id