Autism Spectrum Disorder, Developmental Disability, Development Delay, Development Disorder, Child
Conditions
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.
Interventions
BEHAVIORALCenter Based or In Home 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 or in home to treat social communication deficits in children with developmental disorders.
Sponsors
Stanford University
John & Marcia Goldman Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Contacts
CONTACTMadeleine Clark, BS
CONTACTBeatrice Begley, BS
PRINCIPAL_INVESTIGATORAntonio Hardan, MD
Stanford University
Outcome results
None listed