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

University of Pennsylvania

Status: Enrolling

Conditions: Autistic Disorder; Autism Spectrum Disorder; Autism; Asperger Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06859918

TUNE In 3.0

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Delay Start Group

Other group

Description:

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

Treatment:

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

Immediate Start Group

Experimental group

Description:

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

Treatment:

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