RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ASPE Subproject - Training to Understand and Navigate Emotions and Interactions (TUNE In)

Quick Facts

Study Start:2025-03-24
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06859918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Meet ASD diagnostic criteria supported by an outside diagnostic evaluation and/or by the clinical and developmental information gathered from a phone screen
  3. * Be willing to complete screening surveys (outcome measures)
  4. * Social Responsiveness Score, Second Edition, self-report SRS survey score of greater than or equal to 60
  1. * Severe self-injurious or aggressive behaviors; or with suicidal or homicidal ideation or behaviors (e.g. suicide attempt) within the last 6 months
  2. * Major mood episode (major depressive episode, manic episode), psychotic symptoms, or a psychiatric hospitalization within the last 6 months
  3. * A history of intellectual disability or low Shipley-2 score

Contacts and Locations

Study Contact

Edward Brodkin, M.D
CONTACT
215-746-4100
ebrodkin@pennmedicine.upenn.edu
Giulietta Flaherty, PsyD
CONTACT
7322595506
flahertyg@pennmedicine.upenn.edu

Principal Investigator

Edward Brodkin, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Edward Brodkin, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-24
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Social Skills
  • Emotion Regulation
  • Autistic Adults

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Autism
  • Autistic Disorder
  • Asperger Syndrome