Clinical trial NCT06859918: Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder
Official title: ASPE Subproject - Training to Understand and Navigate Emotions and Interactions (TUNE In)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Autistic Disorder
Asperger Syndrome
Keywords: Social Skills
Emotion Regulation
Autistic Adults
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Social Responsiveness Scale (SRS) - Self Report
timeFrame: From enrollment to 6 months follow up
Secondary outcomes:
measure: Social Responsiveness Scale (SRS) - Informant Report
timeFrame: From enrollment to 6 months follow up
measure: CAT-Q - Camouflaging Autistic Traits Questionnaire
timeFrame: From enrollment to 6 months follow up
measure: Five Facet Mindfulness Questionnaire
timeFrame: From enrollment to 6 months follow up
measure: Generalized Anxiety Disorder-7
timeFrame: From enrollment to 6 months follow up
measure: Glasgow Sensory Questionnaire
timeFrame: From enrollment to 6 months follow up
measure: Insomnia Severity Inde
timeFrame: From enrollment to 6 months follow up
measure: Inventory of Socially Supportive Behaviors
timeFrame: From enrollment to 6 months follow up
measure: Social Network Index
timeFrame: From enrollment to 6 months follow up
measure: Scales of Psychological Wellbeing
timeFrame: From enrollment to 6 months follow up
measure: Attunement Quiz
timeFrame: From enrollment to 6 months follow up
measure: Liebowitz Social Anxiety Scale - Self-Report
timeFrame: From enrollment to 6 months follow up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Edward Brodkin, MD
role: PRINCIPAL_INVESTIGATOR
References: