Autism Spectrum Disorder Clinical Trial
Official title:
Surviving And Thriving In The Real World: A Daily Living Skills Intervention For Adolescents With ASD
Verified date | June 2023 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current study seeks to develop the first daily living skills (DLS) intervention package for high functioning adolescents with autism spectrum disorder (ASD) and evaluate its effectiveness. The investigators hope to further refine the Surviving and Thriving in the Real World (STRW) intervention by conducting an ORBIT (Obesity-Related Behavioral Intervention Trial) Phase 2b feasibility Randomized Clinical Trial (RCT). This randomized clinical trial will test the preliminary effectiveness of STRW in 56 adolescents (14-21 years) with high functioning ASD as compared to a robust evidence-based social skills intervention (Program for the Evaluation and Enrichment of Relational Skills - PEERS). The current proposal represents a critical step toward improving the adult outcome of individuals with autism.
Status | Completed |
Enrollment | 58 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 21 Years |
Eligibility | Inclusion Criteria: - attending high school - a diagnosis of autism spectrum disorder (ASD) (based on meeting the cut-off score on the Autism Diagnostic Observation Schedule, 2nd Edition. - a full scale Intelligence Quotient (IQ) of 70 or above as measured by the Stanford Binet Intelligence Scales, 5th Edition. - deficient daily living skills as assessed by the Vineland-3. Exclusion Criteria: - psychosis or other major psychiatric disorder requiring intensive treatment - the adolescent has already completed the social skills group (PEERS), either at Cincinnati Children's or in another setting, unless it has been a significant amount of time since they did the PEERS group (2-3 years, or up to the discretion of the PI). |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vineland Adaptive Behavior Scales, 3rd Edition | The Vineland Adaptive Behavior Scales, 3rd Edition (VABS-3) is a well-established standardized measure of adaptive behavior that assesses skills in the Communication, Daily Living Skills, and Socialization domains. The DLS domain is comprised of the Personal, Domestic, and Community subdomains and has items that directly correspond to goals being targeted in the STRW intervention. If you add the total points possible for each subdomain, the total Daily Living Skills Domain raw scores can range from 0 to 286. The higher the score, the better the adaptive level. |
At Baseline, at Post-Group (approx. 3 months) |
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