Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Stanford Research Park
RECRUITING
Palo Alto
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 76
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov