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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01NS035193-18 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pivotal Response Training | Active Comparator | Pivotal Response Training with children ages 4-35 years of age with an Autism Spectrum Disorder diagnosis |
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| Waitlist Control | No Intervention | Children in WL will be offered treatment following WL condition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pivotal Response Training | Behavioral | Behavioral intervention for autism |
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| Measure | Description | Time Frame |
|---|---|---|
| Social Responsiveness Scale (SRS) Total Score | 16 weeks |
| 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) |
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Inclusion Criteria:
Participants will:
Exclusion Criteria:
Participants may not have:
Any metal or electromagnetic implants, including:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Child Study Center - Autism Program | New Haven | Connecticut | 06512 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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 |