Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder

NCT06859918 | Recruiting

• 1 other identifier: TUNE In 3.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a novel, 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 Spectrum Disorder; Autism; Autistic Disorder; Asperger Syndrome

Keywords

Social Skills; Emotion Regulation; Autistic Adults

Outcome Measures

Primary Outcomes (1)

• Social Responsiveness Scale (SRS) - Self Report

  A 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.

  From enrollment to 6 months follow up

Secondary Outcomes (11)

• Social Responsiveness Scale (SRS) - Informant Report

  From enrollment to 6 months follow up

• CAT-Q - Camouflaging Autistic Traits Questionnaire

  From enrollment to 6 months follow up

• Five Facet Mindfulness Questionnaire

  From enrollment to 6 months follow up

• Generalized Anxiety Disorder-7

  From enrollment to 6 months follow up

• Glasgow Sensory Questionnaire

  From enrollment to 6 months follow up

Study Arms (2)

Delay Start Group

OTHER

The Delay Start Group receives the intervention 1-6 months after the Immediate Start Group.

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

Immediate Start Group

EXPERIMENTAL

The Immediate Start Group receives the intervention as soon as the trial starts.

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

Interventions

TUNE In: Training to Understand and Navigate Emotions and Interactions BEHAVIORAL

A 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, and social skills.

Delay Start Group; Immediate Start Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Meet ASD diagnostic criteria supported by an outside diagnostic evaluation and/or by the clinical and developmental information gathered from a phone screen
• Be willing to complete screening surveys (outcome measures)
• Social Responsiveness Score, Second Edition, self-report SRS survey score of greater than or equal to 60

You may not qualify if:

• Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months
• Major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months
• A history of intellectual disability or low Shipley-2 score

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome; Social Skills; Emotional Regulation

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior; Self-Control

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Edward Brodkin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Brodkin, M.D

CONTACT

215-746-4100; ebrodkin@pennmedicine.upenn.edu

Brodkin Lab

CONTACT

tunein.aspe@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study involves two groups of participants, who both receive the intervention at different times. The "Immediate Start Group" will get the intervention at the beginning of the trial, while the "Delay Start Group" will receive the intervention 1-6 months after the Immediate Start Group. Participants will be randomly assigned to groups.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Deidentified data will be uploaded to NDAR upon completion of the trial

Locations

US (1)