Randomized Clinical Trial of TUNE In 3.0: A Social/Emotional Program for Adults With Autism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TUNE In: Training to Understand and Navigate Emotions and Interactions
BehavioralA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Delay Start GroupOther 1 intervention
Group B: Immediate Start GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Social Responsiveness Scale (SRS) - Self Report
A 65 item self-report measure that identifies the presence and severity of social impairment within the autism spectrum.
Time frame
From enrollment to 6 months follow upSecondary outcomes
1
Social Responsiveness Scale (SRS) - Informant Report
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.
Time frame
From enrollment to 6 months follow up2
CAT-Q - Camouflaging Autistic Traits Questionnaire
A 25 item measure that assesses the extent to which individuals with autism mask or camouflage their autistic traits in social situations.
Time frame
From enrollment to 6 months follow up3
Five Facet Mindfulness Questionnaire
A 39-item measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity.
Time frame
From enrollment to 6 months follow up4
Generalized Anxiety Disorder-7
A 7-item measure that assesses the severity of generalized anxiety disorder symptoms.
Time frame
From enrollment to 6 months follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov