Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788537
• Other study ID #: 820694
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Asperger Syndrome
• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Pervasive Developmental Disorder

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