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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autistic Disorder; Autism; Asperger Syndrome
• Intervention / Treatment: Behavioral: TUNE In: Training to Understand and Navigate Emotions and Interactions

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward Brodkin, M.D; Phone Number: 215-746-4100; Email: ebrodkin@pennmedicine.upenn.edu
• Study Contact Backup: Name: Brodkin Lab; Email: tunein.aspe@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania
      • Contact: Giulietta Flaherty; Email: flahertyg@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Delay Start Group; The Delay Start Group receives the intervention 1-6 months after the Immediate Start Group.	Behavioral: 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.
Experimental: Immediate Start Group; The Immediate Start Group receives the intervention as soon as the trial starts.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Responsiveness Scale (SRS) - Self Report	A 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.	From enrollment to 6 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Responsiveness Scale (SRS) - Informant Report	A 65 item measure that identifies the presence and severity of social impairment within the autism spectrum. This is completed by a friend/family member of the participant based on their perceptions of the participants' behavior.	From enrollment to 6 months follow up
CAT-Q - Camouflaging Autistic Traits Questionnaire	A 25 item measure that assesses the extent to which individuals with autism mask or camouflage their autistic traits in social situations.	From enrollment to 6 months follow up
Five Facet Mindfulness Questionnaire	A 39-item measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.	From enrollment to 6 months follow up
Generalized Anxiety Disorder-7	A 7-item measure that assesses the severity of generalized anxiety disorder symptoms.	From enrollment to 6 months follow up
Glasgow Sensory Questionnaire	A 42-item measure that assesses sensory sensitivities and differences across multiple sensory modalities.	From enrollment to 6 months follow up
Insomnia Severity Inde	A 7-item measure that assesses the severity of insomnia symptoms and their impact on daily functioning.	From enrollment to 6 months follow up
Inventory of Socially Supportive Behaviors	A 40-item measure that assesses the frequency and types of social support individuals receive.	From enrollment to 6 months follow up
Social Network Index	A 12-item measure that assesses the size, diversity, and level of engagement in an individual's social network.	From enrollment to 6 months follow up
Scales of Psychological Wellbeing	A 42 item measure that assesses six dimensions of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.	From enrollment to 6 months follow up
Attunement Quiz	A 25 item measure that assess attunement: one's ability to perceive, interpret, and respond to one's internal and external environment, in particular the social environment.	From enrollment to 6 months follow up
Liebowitz Social Anxiety Scale - Self-Report	A 24-item measure that assesses the severity of social anxiety symptoms related to fear and avoidance in social and performance situations.	From enrollment to 6 months follow up

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Edward Brodkin, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Emotion Regulation; Social Skills; Autistic Adults
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Social Behavior; Self-Control; Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome; Social Skills; Emotional Regulation; Physiological Phenomena; Pharmacological and Toxicological Phenomena; Pharmacological Phenomena; Drug Interactions
• Other Study ID Numbers: TUNE In 3.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available through NIH NDAR registry
• IPD Sharing Time Frame: Deidentified data will be uploaded to NDAR upon completion of the trial
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No