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| Name | Class |
|---|---|
| John & Marcia Goldman Foundation | UNKNOWN |
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The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (ASD).
The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social communication deficits in children with autism spectrum disorder (ASD). The study will compare Pivotal Response Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral intervention based on the principles of applied behavior analysis which has shown to be effective in treating the core deficits in children with ASD. The study will compare the combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will include 44 children ages 2 to 3.11 years with ASD and social communication deficits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Center-Based Pivotal Response Treatment (PRT-C) | Experimental | Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours. |
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| Delayed Treatment Group (DTG) | No Intervention | Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Center-Based Pivotal Response Treatment (PRT-C) | Behavioral | Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks | Baseline and Week 12 | |
| Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks | Baseline and Week 12 | |
| Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks | Baseline and Week 12 | |
| Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Y. Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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