PRT for Adolescents With High Functioning Autism

March 26, 2024 updated by: Daniel Abrams, Stanford University

Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: PRT for Adolescents
Clinician-led 70-minute PRT sessions targeting social skills once per week at Stanford.
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.
Behavioral: PRT for Adolescents
Clinician-led 70-minute PRT sessions targeting social skills once per week at Stanford.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(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.
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
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.
Pre-treatment baseline, and between 11 to 13 weeks post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC)
Time Frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
The Brief Observation of Social Communication Change (BOSCC) is a clinical instrument developed to measure longitudinal and/or training-related changes in social communication abilities in children with autism spectrum disorder. The metric used to characterize the BOSCC is the Social Communication subscale. Change in the Social Communication subscale will be computed for each participant in the PRT group by subtracting Post- from Pre-training Social Communication subscale scores.
Pre-treatment baseline, and between 11 to 13 weeks post-baseline
(Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)
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 temporoparietal junction (TPJ) an important brain system for theory-of-mind processing. For the PRT 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 TPJ 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.
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)
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). Brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and NAc as the target region. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-NAc connectivity betas, for each PRT participant. Change in clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. Association between change in target engagement and change in clinical benefit will be computed by performing Pearson's correlation using STS-NAc connectivity change as the independent variable and SLO percentage of appropriate social responsiveness as the dependent variable. Effect size will be the Pearson's r value.
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)
Time Frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Target engagement consists of brain connectivity between voice selective STS and the TPJ. Brain connectivity will be measured using the generalized psychophysiological interaction (gPPI) model. gPPI betas from individual subject contrast maps will be computed using the STS as a seed region and TPJ as the target region. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-TPJ connectivity betas, for each PRT participant. Change in clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. Association between change in target engagement and change in clinical benefit will be computed by performing Pearson's correlation using STS-TPJ connectivity change as the independent variable and SLO percentage of appropriate social responsiveness as the dependent variable. Effect size will be the Pearson's r value.
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)
Time Frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Target engagement consists of brain connectivity between voice selective STS and the NAc. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-NAc connectivity betas, for each participant in PRT and DTG groups. Clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. To examine PRT vs. DTG group differences in associations between target engagement and clinical gains, separate Pearson's correlation for PRT and DTG groups will be computed, using STS-NAc connectivity change as the independent variable and SLO score change as the dependent variable. Pearson's r values will be Fisher transformed to z-scores, and the DTG-group Fisher-transformed z-score will be subtracted from the PRT-group z-score to yield a group difference z-score. Effect size for the PRT vs. DTG group comparison is calculated as the group difference z-score.
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)
Time Frame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Target engagement consists of brain connectivity between voice selective STS and the TPJ. Change in target engagement will be measured by Post- minus Pre-Training difference scores, using task-based STS-TPJ connectivity betas, for each participant in PRT and DTG groups. Clinical benefit will be measured using Post- minus Pre-Training SLO percentage of appropriate social responsiveness for each participant. To examine PRT vs. DTG group differences in associations between target engagement and clinical gains, separate Pearson's correlation for PRT and DTG groups will be computed, using STS-TPJ connectivity change as the independent variable and SLO score change as the dependent variable. Pearson's r values will be Fisher transformed to z-scores, and the DTG-group Fisher-transformed z-score will be subtracted from the PRT-group z-score to yield a group difference z-score. Effect size for the PRT vs. DTG group comparison is calculated as the group difference z-score.
Pre-treatment baseline, and between 11 to 13 weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Dani A Abrams, Ph.D., Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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