Asperger Syndrome, Autism, Autism Spectrum Disorder, Autistic Disorder, Pervasive Developmental Disorder
Conditions
Keywords
Autism, Autism Spectrum Disorder, Cognitive Behavioral Therapy
Brief summary
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.
Interventions
BEHAVIORALTraining 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants randomly assigned to either the intervention group (50%) or nonintervention group (50%).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* diagnosis of autism spectrum disorder
Exclusion criteria
* intellectual disability * severe mood or psychotic symptoms experienced in the past 4 weeks * severe self-injurious or aggressive behavior * severe extrapyramidal motor or sedating side effects of medications * concomitant participation in another social skills treatment program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) | Baseline and Post-Treatment (~1 year after baseline) | Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Nonintervention Group Treatment As Usual | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | Intervention Group | Nonintervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Age, Continuous | 28.82 Years STANDARD_DEVIATION 10.4 | 27 Years STANDARD_DEVIATION 8.76 | 27.91 Years STANDARD_DEVIATION 9.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 21 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 19 Participants | 36 Participants |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
| Shipley-2 - Vocabulary | 118.77 Scores on a Scale STANDARD_DEVIATION 6.44 | 114.33 Scores on a Scale STANDARD_DEVIATION 12.23 | 117.16 Scores on a Scale STANDARD_DEVIATION 8.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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.
Time frame: Baseline and Post-Treatment (~1 year after baseline)
Population: 2 Participants began but failed to complete TUNE In. 2 TAU participants lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) | Baseline | 68.67 Scaled Score | Standard Deviation 5.33 |
| Intervention Group | Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) | Post-Treatment | 66.08 Scaled Score | Standard Deviation 10.9 |
| Nonintervention Group | Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) | Baseline | 70.41 Scaled Score | Standard Deviation 6.7 |
| Nonintervention Group | Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report) | Post-Treatment | 72.33 Scaled Score | Standard Deviation 6.04 |
p-value: 0.006Mixed Models Analysis