Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04788537
Collaborator
(none)
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Study Details

Study Description

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.

We 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Training to Understand and Navigate Emotions and Interactions (TUNE In)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
Actual Study Start Date :
Feb 16, 2021
Anticipated Primary Completion Date :
Dec 22, 2022
Anticipated Study Completion Date :
Dec 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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.

No Intervention: Nonintervention Group

Outcome Measures

Primary Outcome Measures

  1. reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (relative/other report) [1 year]

    Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Perelman School of Medicine Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04788537
Other Study ID Numbers:
  • 820694
First Posted:
Mar 9, 2021
Last Update Posted:
Mar 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2021