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| Name | Class |
|---|---|
| Anonymous Donor | UNKNOWN |
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The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) | Experimental | A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits. |
|
| Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H) | Experimental | A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits. |
|
| Treatment As Usual (TAU) | No Intervention | This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C) | Behavioral | Pivotal Response Treatment in autism center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Child Utterances during the Parent-Child portion of the Structured Lab Observation (SLO). | Baseline,16 Weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change on MacArthur-Bates Communication Development Inventory (CDI) Scores | Baseline,16 Weeks. | |
| Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores | Baseline,16 Weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Parent Rated Emotion Dysregulation Inventory-Young Child (EDI-YC) Scores | Baseline,16 Weeks. | |
| Change From Baseline in the Parent Rated General Self Efficacy Scale (GSES) Scores | Baseline,16 Weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maddy Clark | Contact | (650)736-1235 | PALprogram@stanford.edu | |
| Beatrice Begley | Contact | (650)736-1235 | PALprogram@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Y. Hardan, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D003142 | Communication |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007041 | Hypoxanthine Phosphoribosyltransferase |
| D008722 | Methods |
| ID | Term |
|---|---|
| D010430 | Pentosyltransferases |
| D016695 | Glycosyltransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
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Outcome raters and video coding rating are blinded to group.
| Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H) | Behavioral | Pivotal Response Treatment in home environment. |
|
| Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) Scores | Social Responsiveness Scale, 2nd Edition (SRS-2) scores measure social abilities with lower scores meaning better social abilities. | Baseline,16 Weeks. |
| Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores | Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290). | Baseline,16 Weeks. |
| Change on the Brief Observation of Social Communication Change (BOSCC) direct child observation assessment. | Baseline,16 Weeks. |
| Change on the Clinical Global Impressions (CGI) Scale. | Baseline,16 Weeks. |
| Change From Baseline in the Parent Rated Sensory Experiences Questionnaire (SEQ) Scores | Baseline,16 Weeks. |
| Change From Baseline in the Parent Rated Child and Family Quality of Life - 2 (CFQL-2) Scores | Baseline,16 Weeks. |
| Change From Baseline in the Parent Rated Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P) Scores | Baseline,16 Weeks. |
| Change From Baseline in the Parent Rated Family Empowerment Scale (FES) Scores | Baseline,16 Weeks. |
| Change From Baseline in the Parent Rated Parent Motivation Inventory (PMI) Scores | Baseline,16 Weeks. |
| Change From Baseline in the Parent Rated Parent Stress Index, Short Form (PSI/SF) Scores | Baseline,16 Weeks. |
| Change From Baseline in the Parent Rated Dimensional Assessment of Repetitive Behaviors (DARB) Scores | Baseline,16 Weeks. |
| D045762 |
| Enzymes and Coenzymes |
| D008919 | Investigative Techniques |