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NCT Number: NCT05987761

PRT for Adolescents With High Functioning Autism

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).

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Key information

Conditions

Autism Autism Spectrum Disorder Autism Spectrum Disorder High-Functioning Autistic Disorder Behavior Behavior, Child Behavior, Social Child Behavior Child Development Child Development Disorders, Pervasive Developmental Disabilities Developmental Disability Mental Disorders Neurodevelopmental Disorders Social Behavior Social Skills

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Research Park

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Daniel A Abrams, Ph.D.

PRINCIPAL_INVESTIGATOR

Lynn Koegel, Ph.D.

CONTACT

[email protected]

Study Team

CONTACT

[email protected]

650-485-3149

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRT for Adolescents

Behavioral

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

Primary outcomes

  1. (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.

  2. 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

  1. 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.

  2. (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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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