PRT-I: Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Study Details
Study Description
Brief Summary
Autism spectrum disorder (ASD) is a very heterogeneous disorder with limited empirically validated behavioral and biological interventions. The goal of this pilot investigation is to apply a biologically-based approach to identify predictors of treatment response in children with ASD who are receiving Pivotal Response Treatment (PRT), an evidence-based behavioral intervention. Specifically, the investigators propose to identify neuroimaging biomarkers of treatment response to a PRT program (PRT-P) targeting language deficits in young children with ASD who will be randomized to either PRT-P or to a delayed treatment group (DTG).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pivotal Response Treatment Program (PRT-P) The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period. |
Behavioral: Pivotal Response Treatment Program (PRT-P)
The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.
Other Names:
|
| No Intervention: Delayed Treatment Group (DTG) Child continues stable treatments as usual in the community. |
Outcome Measures
Primary Outcome Measures
- Change in Number of Child Utterances During a Structured Lab Observation (SLO) [Baseline, 16 Weeks]
Secondary Outcome Measures
- Change on MacArthur-Bates Communication Development Inventory (CDI) [Baseline, 16 Weeks]
Other Outcome Measures
- Change on Preschool Language Scale, 5th Edition (PLS-5) [Baseline, 16 Weeks]
- Change on Mullen Scales of Early Learning [Baseline, 16 Weeks]
- Change on Vineland Adaptive Behaviors Scales, 3rd Edition [Baseline, 16 Weeks]
- Change on Clinical Global Impressions Scale (CGI) [Baseline, 16 Weeks]
- Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment [Baseline, 16 Weeks]
- Change on Parent Stress Index (PSI) [Baseline, 16 Weeks]
- Change on Family Empowerment Scale (FES) [Baseline, 16 Weeks]
- Change on General Self Efficacy Scale (GSES) [Baseline, 16 Weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Autism Spectrum Spectrum Disorder (ASD) based on clinical interview and Diagnostic and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic Interview Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) and/or Brief Observation of Symptoms of Autism (BOSA) and/or Childhood Autism Rating Scale- Second Edition (CARS-2).
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Outpatients between 2.0 and 4.11 years of age of either gender,
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Children of all cognitive levels will be included as long as they are able to participate in the testing procedures to the extent that valid standard scores can be obtained
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Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5) [at least 1 standard deviation behind for children age 2 and 3 years; and 2 standard deviations behind for children age 4],
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Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
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Stable treatment [Applied Behavior Analysis (ABA), Floortime, or other interventions], speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
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No more than 60 minutes of 1:1 speech therapy per week,
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The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress,
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The availability of at least one parent who can consistently participate in the training sessions and related activities, and
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Successful completion of baseline brain scan.
Exclusion Criteria:
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Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder),
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Genetic abnormality (e.g., Fragile X)
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Presence of active medical problem (e.g., unstable seizure disorder),
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Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week
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Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or
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Previous adequate Pivotal Response Treatment (PRT) trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Stanford | California | United States | 94305-5719 |
Sponsors and Collaborators
- Stanford University
- National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
- Principal Investigator: Antonio Hardan, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-46131