Autism Spectrum Disorder Clinical Trial
Official title:
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
NCT number | NCT04788537 |
Other study ID # | 820694 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 16, 2021 |
Est. completion date | June 22, 2023 |
Verified date | August 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test a novel, three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 22, 2023 |
Est. primary completion date | June 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - diagnosis of autism spectrum disorder Exclusion Criteria: - intellectual disability - severe mood or psychotic symptoms experienced in the past 4 weeks - severe self-injurious or aggressive behavior - severe extrapyramidal motor or sedating side effects of medications - concomitant participation in another social skills treatment program. |
Country | Name | City | State |
---|---|---|---|
United States | Perelman School of Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (relative/other report) | Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology. | 1 year |
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