Trial Outcomes & Findings for Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders (NCT NCT04788537)
NCT ID: NCT04788537
Last Updated: 2025-03-21
Results Overview
Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline and Post-Treatment (~1 year after baseline)
Results posted on
2025-03-21
Participant Flow
Participant milestones
| Measure |
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.
|
Nonintervention Group
Treatment As Usual
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Services to Enhance Social Functioning in Adults With Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Intervention Group
n=22 Participants
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.
|
Nonintervention Group
n=22 Participants
Treatment As Usual
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
28.82 Years
STANDARD_DEVIATION 10.40 • n=99 Participants
|
27 Years
STANDARD_DEVIATION 8.76 • n=107 Participants
|
27.91 Years
STANDARD_DEVIATION 9.55 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Shipley-2 - Vocabulary
|
118.77 Scores on a Scale
STANDARD_DEVIATION 6.44 • n=99 Participants
|
114.33 Scores on a Scale
STANDARD_DEVIATION 12.23 • n=107 Participants
|
117.16 Scores on a Scale
STANDARD_DEVIATION 8.68 • n=206 Participants
|
PRIMARY outcome
Timeframe: 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
Scale ranges from 30 to 90 with higher T-scores indicating greater severity of autism symptomatology.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
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.
|
Nonintervention Group
n=22 Participants
Treatment As Usual
|
|---|---|---|
|
Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report)
Baseline
|
68.67 Scaled Score
Standard Deviation 5.33
|
70.41 Scaled Score
Standard Deviation 6.70
|
|
Reduction in Social Responsiveness Scale, Second Edition (SRS-2) - Adult (Relative/Other Report)
Post-Treatment
|
66.08 Scaled Score
Standard Deviation 10.90
|
72.33 Scaled Score
Standard Deviation 6.04
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nonintervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place