Pivotal Response Treatment for Children With Autism Spectrum Disorders

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT) to children ages four through six years of age with ASD. Specifically, children will be randomly assigned to receive either (1) 10 hours per week of intervention services, including two hours per week of parent education, and eight hours per week of direct clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Behavioral: Pivotal Response Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Participants will: Fit the age requirement: age 4-35 Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team. Be in good medical health Be cooperative with testing English is a language spoken in the family Successfully complete an fMRI and EEG scan Full-scale IQ>50 Exclusion Criteria: Exclusion Criteria: Participants may not have: Any metal or electromagnetic implants, including: Cardiac pacemaker Defibrillator Artificial heart valve Aneurysm clip Cochlear implants Shrapnel Neurostimulators History of metal fragments in eyes or skin Significant hearing loss or other severe sensory impairment A fragile health status. Current use of prescription medications that may affect cognitive processes under study. A history of significant head trauma or serious brain or psychiatric illness

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 35 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pivotal Response Training<br>Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis | Behavioral: Pivotal Response Training<br>* Behavioral intervention for autism<br>* Other names: Pivotal Response Treatment;|
| No Intervention: Waitlist Control<br>Children in WL will be offered treatment following WL condition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale (SRS) Total Score |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions Scale (CGI-I) |  | 16 weeks | 
| Autism Diagnostic Observation Schedule (ADOS) Comparison Score |  | 16 weeks | 
| Aberrant Behavior Checklist (ABC) |  | 16 weeks | 
| Vineland Domain Scores |  | 16 weeks | 
| Change in Eye Tracking (ET) patterns |  | 16 weeks | 
| Change in neural response to social stimuli using fMRI |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD