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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DC016089-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pivotal Response Treatment Program (PRT-P) | Experimental | 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. |
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| Delayed Treatment Group (DTG) | No Intervention | Child continues stable treatments as usual in the community. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pivotal Response Treatment Program (PRT-P) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Child Utterances During a Structured Lab Observation (SLO) | Baseline, 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change on MacArthur-Bates Communication Development Inventory (CDI) | Baseline, 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Estefania Millan, MA | Contact | (650) 736-1235 | mmillan2@stanford.edu | |
| John Hegarty, PhD | Contact | (650) 736-1235 | hegartyj@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305-5719 | United States |
We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
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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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| 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 |