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

Not Applicable

Recruiting

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

• Registration Number: NCT06859918
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-05
• Study Start: 2025-03-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS) - Informant Report	From enrollment to 6 months follow up	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.
CAT-Q - Camouflaging Autistic Traits Questionnaire	From enrollment to 6 months follow up	A 25 item measure that assesses the extent to which individuals with autism mask or camouflage their autistic traits in social situations.
Five Facet Mindfulness Questionnaire	From enrollment to 6 months follow up	A 39-item measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.
Glasgow Sensory Questionnaire	From enrollment to 6 months follow up	A 42-item measure that assesses sensory sensitivities and differences across multiple sensory modalities.
Generalized Anxiety Disorder-7	From enrollment to 6 months follow up	A 7-item measure that assesses the severity of generalized anxiety disorder symptoms.
Insomnia Severity Inde	From enrollment to 6 months follow up	A 7-item measure that assesses the severity of insomnia symptoms and their impact on daily functioning.
Inventory of Socially Supportive Behaviors	From enrollment to 6 months follow up	A 40-item measure that assesses the frequency and types of social support individuals receive.
Social Network Index	From enrollment to 6 months follow up	A 12-item measure that assesses the size, diversity, and level of engagement in an individual's social network.
Scales of Psychological Wellbeing	From enrollment to 6 months follow up	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.
Attunement Quiz	From enrollment to 6 months follow up	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.
Liebowitz Social Anxiety Scale - Self-Report	From enrollment to 6 months follow up	A 24-item measure that assesses the severity of social anxiety symptoms related to fear and avoidance in social and performance situations.

Trial Locations

Locations (1)

Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States