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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delay Start Group | Other | The Delay Start Group receives the intervention 1-6 months after the Immediate Start Group. |
|
| Immediate Start Group | Experimental | The Immediate Start Group receives the intervention as soon as the trial starts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 6 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Brodkin, M.D | Contact | 215-746-4100 | ebrodkin@pennmedicine.upenn.edu | |
| Brodkin Lab | Contact | tunein.aspe@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Edward Brodkin, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brodkin Lab: Perelman School of Medicine, Department of Psychiatry, University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
Data will be available through NIH NDAR registry
Deidentified data will be uploaded to NDAR upon completion of the trial
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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.
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|
| 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. |
| From enrollment to 6 months follow up |
| Five Facet Mindfulness Questionnaire | A 39-item measure that assesses five aspects of mindfulness: observing, describing, acting with awareness, non-judging, and non-reactivity. | From enrollment to 6 months follow up |
| Generalized Anxiety Disorder-7 | A 7-item measure that assesses the severity of generalized anxiety disorder symptoms. | From enrollment to 6 months follow up |
| Glasgow Sensory Questionnaire | A 42-item measure that assesses sensory sensitivities and differences across multiple sensory modalities. | From enrollment to 6 months follow up |
| Insomnia Severity Inde | A 7-item measure that assesses the severity of insomnia symptoms and their impact on daily functioning. | From enrollment to 6 months follow up |
| Inventory of Socially Supportive Behaviors | A 40-item measure that assesses the frequency and types of social support individuals receive. | From enrollment to 6 months follow up |
| Social Network Index | A 12-item measure that assesses the size, diversity, and level of engagement in an individual's social network. | From enrollment to 6 months follow up |
| Scales of Psychological Wellbeing | 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. | From enrollment to 6 months follow up |
| Attunement Quiz | 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. | From enrollment to 6 months follow up |
| Liebowitz Social Anxiety Scale - Self-Report | A 24-item measure that assesses the severity of social anxiety symptoms related to fear and avoidance in social and performance situations. | From enrollment to 6 months follow up |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D066107 | Social Skills |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D000068356 | Self-Control |
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| ID | Term |
|---|---|
| D004347 | Drug Interactions |
| ID | Term |
|---|---|
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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