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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 a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Center Based or In-Home Early Intervention Program | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Center Based or In Home Early Intervention Program | Behavioral | This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment or in home to treat social communication deficits in children with developmental disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. | Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 ) | Baseline, 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129) | Baseline, 12 Weeks |
| Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madeleine Clark, BS | Contact | (650) 736-1235 | PALprogram@stanford.edu | |
| Beatrice Begley, BS | Contact | (650) 736-1235 | PALprogram@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio 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 |
|---|---|
| D002658 | Developmental Disabilities |
| D007859 | Learning Disabilities |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290). |
| Baseline, 12 Weeks |
| Change From Baseline in Parent Rated Vineland Adaptive Behavior Scale- 3 (VABS-3) Scores During Treatment. | Baseline, 12 Weeks |
| Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment. | Baseline, 12 Weeks |
| Change From Baseline in Parent Rated General Self Efficacy Scale (GSES) Scores During Treatment. | Baseline, 12 Weeks |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002659 | Child Development Disorders, Pervasive |