Recruiting

TUNE In 3.0

Sponsor:

University of Pennsylvania

Code:

NCT06859918

Conditions

Autism Spectrum Disorder

Autism

Autistic Disorder

Asperger Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TUNE In: Training to Understand and Navigate Emotions and Interactions

Study Details

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

Study ID

NCT06859918

Start date

Mar 24, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Delay Start Group

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

experimental: Immediate Start Group

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

Interventions

TUNE In: Training to Understand and Navigate Emotions and Interactions

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.

Primary outcome measure

  • Social Responsiveness Scale (SRS) - Self Report [ Time Frame: From enrollment to 6 months follow up ]

Central Contacts and Locations

Central contacts

Edward Brodkin, M.D

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

Brodkin Lab

tunein.aspe@pennmedicine.upenn.edu

Locations

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

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Giulietta Flaherty

flahertyg@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Social Skills
  • Emotion Regulation
  • Autistic Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-13.