PRT for Adolescents With High Functioning Autism

NCT05987761 | Recruiting

• 1 other identifier: 60502
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• (Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)

  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

  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 Outcomes (6)

• 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

• (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

• 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

• 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

Study Arms (2)

PRT Treatment Group

EXPERIMENTAL

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

Delayed Treatment Group

EXPERIMENTAL

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

Interventions

PRT for Adolescents BEHAVIORAL

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

Delayed Treatment Group; PRT Treatment Group

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Research Park

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Developmental Disabilities; Child Behavior; Social Behavior; Autism Spectrum Disorder; Social Skills

Interventions

Hypoxanthine Phosphoribosyltransferase

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Pentosyltransferases; Glycosyltransferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Dani A Abrams, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)