Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
Primary Purpose
Autism, Autism Spectrum Disorder, Autistic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training to Understand and Navigate Emotions and Interactions (TUNE In)
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, Autism Spectrum Disorder, Cognitive Behavioral Therapy
Eligibility Criteria
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.
Sites / Locations
- Perelman School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Nonintervention Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04788537
First Posted
March 2, 2021
Last Updated
August 30, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04788537
Brief Title
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
Official Title
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Pervasive Developmental Disorder
Keywords
Autism, Autism Spectrum Disorder, Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Nonintervention Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Training to Understand and Navigate Emotions and Interactions (TUNE In)
Intervention Description
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.
Primary Outcome Measure Information:
Title
reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (relative/other report)
Description
Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available through NIH NDAR registry
IPD Sharing Time Frame
Deidentified data will be uploaded to NDAR upon completion of the trial
Learn more about this trial
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
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