NCT06859918 Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder
| NCT ID | NCT06859918 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-03-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Edward Brodkin, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06859918 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06859918 currently recruiting?
Yes, NCT06859918 is actively recruiting participants. Contact the research team at ebrodkin@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06859918 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06859918 clinical trial?
NCT06859918 is sponsored by University of Pennsylvania. The principal investigator is Edward Brodkin, MD at University of Pennsylvania. The trial plans to enroll 40 participants.