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Recruiting NCT06859918

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

No phase Interventional Autism Spectrum Disorder Autism Autistic Disorder Asperger Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TUNE In: Training to Understand and Navigate Emotions and Interactions.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Autism, Autistic Disorder, Asperger Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Social Responsiveness Scale (SRS) - Self Report [Time frame: From enrollment to 6 months follow up]
Secondary outcome measures (11)
  • Social Responsiveness Scale (SRS) - Informant Report [Time frame: From enrollment to 6 months follow up]
  • CAT-Q - Camouflaging Autistic Traits Questionnaire [Time frame: From enrollment to 6 months follow up]
  • Five Facet Mindfulness Questionnaire [Time frame: From enrollment to 6 months follow up]
  • Generalized Anxiety Disorder-7 [Time frame: From enrollment to 6 months follow up]
  • Glasgow Sensory Questionnaire [Time frame: From enrollment to 6 months follow up]
  • Insomnia Severity Inde [Time frame: From enrollment to 6 months follow up]
  • Inventory of Socially Supportive Behaviors [Time frame: From enrollment to 6 months follow up]
  • Social Network Index [Time frame: From enrollment to 6 months follow up]
  • Scales of Psychological Wellbeing [Time frame: From enrollment to 6 months follow up]
  • Attunement Quiz [Time frame: From enrollment to 6 months follow up]
  • Liebowitz Social Anxiety Scale - Self-Report [Time frame: From enrollment to 6 months follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylv — Philadelphia

Identifiers

NCT: NCT06859918 · TUNE In 3.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗