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NCT Number: NCT06859918

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

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.

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Key information

Conditions

Autism Spectrum Disorder Asperger Syndrome Autism Autistic Disorder Behavior Child Development Disorders, Pervasive Emotional Regulation Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior Social Skills

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Giulietta Flaherty

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TUNE In: Training to Understand and Navigate Emotions and Interactions

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.

Primary outcomes

  1. Social Responsiveness Scale (SRS) - Self Report

    Time frame: 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 outcomes

  1. Social Responsiveness Scale (SRS) - Informant Report

    Time frame: 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.

  2. CAT-Q - Camouflaging Autistic Traits Questionnaire

    Time frame: 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.

  3. Five Facet Mindfulness Questionnaire

    Time frame: 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.

  4. Generalized Anxiety Disorder-7

    Time frame: From enrollment to 6 months follow up

    A 7-item measure that assesses the severity of generalized anxiety disorder symptoms.

  5. Glasgow Sensory Questionnaire

    Time frame: From enrollment to 6 months follow up

    A 42-item measure that assesses sensory sensitivities and differences across multiple sensory modalities.

  6. Insomnia Severity Inde

    Time frame: From enrollment to 6 months follow up

    A 7-item measure that assesses the severity of insomnia symptoms and their impact on daily functioning.

  7. Inventory of Socially Supportive Behaviors

    Time frame: From enrollment to 6 months follow up

    A 40-item measure that assesses the frequency and types of social support individuals receive.

  8. Social Network Index

    Time frame: 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.

  9. Scales of Psychological Wellbeing

    Time frame: 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.

  10. Attunement Quiz

    Time frame: 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.

  11. Liebowitz Social Anxiety Scale - Self-Report

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brodkin Lab

CONTACT

[email protected]

Edward Brodkin, M.D

CONTACT

[email protected]

215-746-4100

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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