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The purpose of this study is to test a novel, three-part 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 |
|---|---|---|---|
| Intervention Group | Experimental |
| |
| Nonintervention Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training to Understand and Navigate Emotions and Interactions (TUNE In) | Behavioral | A three-part 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, social skills, and generalization of the skills to community settings. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) | Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology. | Baseline and Post-Treatment (~1 year after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
Data will be available through NIH NDAR registry
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Deidentified data will be uploaded to NDAR upon completion of the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Training to Understand and Navigate Emotions and Interactions (TUNE In): A three-part 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, social skills, and generalization of the skills to community settings. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2024 | Dec 5, 2024 |
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Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).
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| FG001 | Nonintervention Group | Treatment As Usual |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Training to Understand and Navigate Emotions and Interactions (TUNE In): A three-part 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, social skills, and generalization of the skills to community settings. |
| BG001 | Nonintervention Group | Treatment As Usual |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Shipley-2 - Vocabulary | Scores on a scale of 100 = "Average" Vocabulary. Greater scores reflect greater verbal ability. Participants were required to score about 70 to qualify for study. The range of the scale has a minimum of 40 and a maximum of 140. | Mean | Standard Deviation | Scores on a Scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) | Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology. | 2 Participants began but failed to complete TUNE In. 2 TAU participants lost to follow-up | Posted | Mean | Standard Deviation | Scaled Score | Baseline and Post-Treatment (~1 year after baseline) |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Training to Understand and Navigate Emotions and Interactions (TUNE In): A three-part 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, social skills, and generalization of the skills to community settings. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG001 | Nonintervention Group | Treatment As Usual | 0 | 22 | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward S Brodkin, MD | University of Pennsylvania | 1-215-746-0118 | ebrodkin@pennmedicine.upenn.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2020 | Dec 5, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D020817 | Asperger Syndrome |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Post-Treatment |
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