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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
Training to Understand and Navigate Emotions and Interactions (TUNE In)
A three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. TUNE In 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.

Locations

Country Name City State
United States Perelman School of Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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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