NCT05987761 · Stanford University
PRT for Adolescents With High Functioning Autism
What this study is about
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).
View original scientific description
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
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Palo Alto, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 28, 2024 · Source of record for eligibility and locations