Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Study Overview
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Brief Summary
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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).

Official Title
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Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

Conditions
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Autism, Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Pivotal Response Treatment Program (PRT-P)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Outpatients between 2.0 and 4.11 years of age of either gender, 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 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], Stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation, 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, No more than 60 minutes of 1:1 speech therapy per week, The child's exposure to the English language must be sufficient that administration of standardized tests in English is appropriate for measuring progress, The availability of at least one parent who can consistently participate in the training sessions and related activities, and Successful completion of baseline brain scan. Exclusion Criteria: Current or life-time diagnosis of severe psychiatric disorder (e.g., bipolar disorder), Genetic abnormality (e.g., Fragile X) Presence of active medical problem (e.g., unstable seizure disorder), Receiving more than 15 hours of in home 1:1 Applied Behavior Analysis (ABA) per week Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal), or Previous adequate Pivotal Response Treatment (PRT) trial.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pivotal Response Treatment Program (PRT-P)<br>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)<br>* 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.<br>* Other names: Pivotal Response Treatment;|
| No Intervention: Delayed Treatment Group (DTG)<br>Child continues stable treatments as usual in the community. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Child Utterances During a Structured Lab Observation (SLO) |  | Baseline, 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on MacArthur-Bates Communication Development Inventory (CDI) |  | Baseline, 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pivotal Response Treatment, Imaging