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

NCT ID: NCT06859918

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-24

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder Autism Autistic Disorder Asperger Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Delay Start Group

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

Group Type OTHER

TUNE In: Training to Understand and Navigate Emotions and Interactions

Intervention Type 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.

Immediate Start Group

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

Group Type EXPERIMENTAL

TUNE In: Training to Understand and Navigate Emotions and Interactions

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Brodkin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Edward Brodkin, M.D

Role: CONTACT

215-746-4100

Giulietta Flaherty, PsyD

Role: CONTACT

7322595506

Facility Contacts

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Giulietta Flaherty

Role: primary

Other Identifiers

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TUNE In 3.0

Identifier Type: -

Identifier Source: org_study_id

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