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Recruiting NCT05987761

PRT for Adolescents With High Functioning Autism

No phase Interventional Autism Autism Spectrum Disorder High-Functioning Developmental Disability Child Development

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRT for Adolescents.
Who it may be relevant to
Registry conditions: Autism, Autism Spectrum Disorder High-Functioning, Developmental Disability, Child Development. Basic parameters: 11 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study

Overview

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).

Interventions

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

Primary outcome measures

  • (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]
  • 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]
Secondary outcome measures (6)
  • 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]
  • (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]
  • 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]
  • 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]
  • 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]
  • 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]

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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Research Park — Palo Alto

Identifiers

NCT: NCT05987761 · 60502

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗