A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
- •Boys and girls between 2.0 years and 5.11 years at time of enrollment;
- •Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.
Exclusion Criteria
- •Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
- •Lack of availability during program hours.
Outcomes
Primary Outcomes
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.
Time Frame: 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 Outcomes
- Change From Baseline in Parent Rated Short Sensory Profile Questionnaire (SSPQ) Scores During Treatment.(Baseline, 12 Weeks)
- Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.(Baseline, 12 Weeks)
- Change From Baseline in Parent Rated Stanford Social Dimension Scale (SSDS) Scores During Treatment.(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 General Self Efficacy Scale (GSES) Scores During Treatment.(Baseline, 12 Weeks)
Investigators
Antonio Hardan
Professor
Stanford University