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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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06859918
Enrollment
40
Registered
2025-03-05
Start date
2025-03-24
Completion date
2027-12-01
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asperger Syndrome, Autism, Autism Spectrum Disorder, Autistic Disorder

Keywords

Social Skills, Emotion Regulation, Autistic Adults

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.

Interventions

BEHAVIORALTUNE 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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Social Responsiveness Scale (SRS) - Self ReportFrom enrollment to 6 months follow upA 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.

Secondary

MeasureTime frameDescription
Social Responsiveness Scale (SRS) - Informant ReportFrom enrollment to 6 months follow upA 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 QuestionnaireFrom enrollment to 6 months follow upA 25 item measure that assesses the extent to which individuals with autism mask or camouflage their autistic traits in social situations.
Five Facet Mindfulness QuestionnaireFrom enrollment to 6 months follow upA 39-item measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.
Generalized Anxiety Disorder-7From enrollment to 6 months follow upA 7-item measure that assesses the severity of generalized anxiety disorder symptoms.
Glasgow Sensory QuestionnaireFrom enrollment to 6 months follow upA 42-item measure that assesses sensory sensitivities and differences across multiple sensory modalities.
Insomnia Severity IndeFrom enrollment to 6 months follow upA 7-item measure that assesses the severity of insomnia symptoms and their impact on daily functioning.
Inventory of Socially Supportive BehaviorsFrom enrollment to 6 months follow upA 40-item measure that assesses the frequency and types of social support individuals receive.
Social Network IndexFrom enrollment to 6 months follow upA 12-item measure that assesses the size, diversity, and level of engagement in an individual's social network.
Scales of Psychological WellbeingFrom enrollment to 6 months follow upA 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 QuizFrom enrollment to 6 months follow upA 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-ReportFrom enrollment to 6 months follow upA 24-item measure that assesses the severity of social anxiety symptoms related to fear and avoidance in social and performance situations.

Countries

United States

Contacts

CONTACTEdward Brodkin, M.D
ebrodkin@pennmedicine.upenn.edu215-746-4100
CONTACTBrodkin Lab
tunein.aspe@pennmedicine.upenn.edu
PRINCIPAL_INVESTIGATOREdward Brodkin, MD

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026