A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Study Details
Study Description
Brief Summary
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Center Based Early Intervention Program
|
Behavioral: Center Based Early Intervention Program
This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment to treat social communication deficits in children with developmental disorders.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. [Baseline, 12 Weeks]
Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )
Secondary Outcome Measures
- Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. [Baseline, 12 Weeks]
Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)
- Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment. [Baseline, 12 Weeks]
Higher Scores on the Stanford Social Dimension Scale mean better social functioning and lower scores mean worse social functioning (Range: 58-290).
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
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Boys and girls between 2.0 years and 4.11 years at time of enrollment;
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Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.
Exclusion Criteria:
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Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
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Lack of availability during program hours.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- John & Marcia Goldman Foundation
Investigators
- Principal Investigator: Antonio Hardan, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-52348