Clinical trial NCT05987761: PRT for Adolescents With High Functioning Autism
Official title: Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 76
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: (Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc)
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
measure: Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Secondary outcomes:
measure: Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC)
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
measure: (Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ)
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
measure: Association between change in target engagement and change in clinical benefit (STS and NAc)
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
measure: Association between change in target engagement and change in clinical benefit (STS and TPJ)
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
measure: Group differences in the association between change in target engagement and clinical benefit (STS and NAc)
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
measure: Group differences in the association between change in target engagement and clinical benefit (STS and TPJ)
timeFrame: Pre-treatment baseline, and between 11 to 13 weeks post-baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Research Park
state: California
Study officials:
affiliation: Stanford University
name: Dani A Abrams, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: