Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- Stanford University
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- (Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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).
Investigators
Daniel Abrams
Clinical Assistant Professor
Stanford University
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.
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
Outcomes
Primary Outcomes
(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
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 interactions
Time Frame: Pre-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.
Secondary Outcomes
- (Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Association between change in target engagement and change in clinical benefit (STS and NAc)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Group differences in the association between change in target engagement and clinical benefit (STS and NAc)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Group differences in the association between change in target engagement and clinical benefit (STS and TPJ)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)
- Association between change in target engagement and change in clinical benefit (STS and TPJ)(Pre-treatment baseline, and between 11 to 13 weeks post-baseline)