Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders

NCT04788537 | Completed Results

• 1 other identifier: 820694
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism; Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome; Pervasive Developmental Disorder

Keywords

Autism; Autism Spectrum Disorder; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Post-Treatment (~1 year after baseline)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Training to Understand and Navigate Emotions and Interactions (TUNE In)

Nonintervention Group

NO INTERVENTION

Interventions

Training to Understand and Navigate Emotions and Interactions (TUNE In) BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of autism spectrum disorder

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Asperger Syndrome; Child Development Disorders, Pervasive

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Results Point of Contact

• Title: Edward S Brodkin, MD
• Organization: University of Pennsylvania

ebrodkin@pennmedicine.upenn.edu

1-215-746-0118

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 9, 2021
• Study Start: February 16, 2021
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified data will be uploaded to NDAR upon completion of the trial

Locations

US (1)