Trial Outcomes & Findings for Enhancing Social Competence in Adults With Autism (NCT NCT04349644)

NCT ID: NCT04349644

Last Updated: 2026-01-29

Results Overview

An event-related Potential Task that presents 51 novel faces and 51 novel houses one of each is randomly selected and presented 50 times (repeated). We are examining an increase in amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Results posted on

2026-01-29

Participant Flow

Excluded (N=8). Not meeting inclusion criteria (N=5), Transportation issues (N=1), and unknown/reason not provided (N=2).

Participant milestones

Participant milestones
Measure
SENSE Theatre
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Allocation/Pretest
STARTED
29
35
Allocation/Pretest
COMPLETED
29
32
Allocation/Pretest
NOT COMPLETED
0
3
Posttest
STARTED
29
32
Posttest
COMPLETED
23
24
Posttest
NOT COMPLETED
6
8
Follow-up
STARTED
23
24
Follow-up
COMPLETED
23
22
Follow-up
NOT COMPLETED
0
2

Reasons for withdrawal

Reasons for withdrawal
Measure
SENSE Theatre
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Allocation/Pretest
Lost to pretest
0
3
Posttest
Lost to posttest
0
8
Posttest
Discontinued intervention
6
0
Follow-up
Lost to Follow-up
0
2

Baseline Characteristics

Enhancing Social Competence in Adults With Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SENSE Theatre
n=29 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=35 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Total
n=64 Participants
Total of all reporting groups
Age, Continuous
24.48 years
STANDARD_DEVIATION 4.92 • n=41 Participants
24.30 years
STANDARD_DEVIATION 5.97 • n=1581 Participants
24.38 years
STANDARD_DEVIATION 5.49 • n=4626 Participants
Sex: Female, Male
Female
14 Participants
n=41 Participants
17 Participants
n=1581 Participants
31 Participants
n=4626 Participants
Sex: Female, Male
Male
15 Participants
n=41 Participants
18 Participants
n=1581 Participants
33 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=41 Participants
1 Participants
n=1581 Participants
3 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants
n=41 Participants
34 Participants
n=1581 Participants
61 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
Asian
0 Participants
n=41 Participants
1 Participants
n=1581 Participants
1 Participants
n=4626 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=41 Participants
4 Participants
n=1581 Participants
7 Participants
n=4626 Participants
Race (NIH/OMB)
White
22 Participants
n=41 Participants
26 Participants
n=1581 Participants
48 Participants
n=4626 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=41 Participants
4 Participants
n=1581 Participants
8 Participants
n=4626 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Region of Enrollment
United States
29 participants
n=41 Participants
35 participants
n=1581 Participants
64 participants
n=4626 Participants
Autism Diagnostic Observation Schedule, 2nd Edition, Module 4
7.34 units on a scale
STANDARD_DEVIATION 1.86 • n=41 Participants
7.51 units on a scale
STANDARD_DEVIATION 1.62 • n=1581 Participants
7.43 units on a scale
STANDARD_DEVIATION 1.73 • n=4626 Participants
Wechsler Abbreviated Scale of Intelligence, 2nd Edition
102.45 units on a scale
STANDARD_DEVIATION 17.21 • n=41 Participants
103.06 units on a scale
STANDARD_DEVIATION 22.86 • n=1581 Participants
102.78 units on a scale
STANDARD_DEVIATION 20.31 • n=4626 Participants

PRIMARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. Two participants in SENSE Theatre and four in Waitlist Control had missing data. For follow-up the number of participants was SENSE Theatre N = 21 and Waitlist Control N = 20. Two participants in SENSE Theatre and two participants in Waitlist Control had missing data.

An event-related Potential Task that presents 51 novel faces and 51 novel houses one of each is randomly selected and presented 50 times (repeated). We are examining an increase in amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=21 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=20 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Change in Incidental Face Memory
Posttest (Week 11)
0.6588 microvolts
Standard Deviation 0.9006
-0.1604 microvolts
Standard Deviation 1.1751
Change in Incidental Face Memory
Follow-up (Week 21)
0.469 microvolts
Standard Deviation 1.279
-0.77 microvolts
Standard Deviation 1.869

PRIMARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. One participant in Waitlist Control had missing data. For follow-up the number of participants was SENSE Theatre N = 23 and Waitlist Control N = 20. Two participants in Waitlist Control had missing data.

An observational assessment measure of social cognition and communication which includes two 3-minutes conversations with typically developing peers showing interested or bored demeanor. The behaviors are rated based on raw scores on a likert scale from 1 to 7 with 7 reflecting better ability. Only the Interested Condiiton was analyzed.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=23 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Change in Contextual Assessment of Social Skills
Vocal Expressiveness Posttest (Week 11)
4.82 units on a scale
Standard Deviation 1.708
4.52 units on a scale
Standard Deviation 1.648
Change in Contextual Assessment of Social Skills
Quality of Rappport Posttest (Week 11)
5.43 units on a scale
Standard Deviation 1.409
5.13 units on a scale
Standard Deviation 1.262
Change in Contextual Assessment of Social Skills
Vocal Expressiveness Follow-up (Week 21)
4.30 units on a scale
Standard Deviation 1.917
4.26 units on a scale
Standard Deviation 1.485
Change in Contextual Assessment of Social Skills
Quality of Rapport Follow-up (Week 21)
5.00 units on a scale
Standard Deviation 1.168
4.85 units on a scale
Standard Deviation 1.226

PRIMARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. One participant in SENSE Theatre had missing data. For follow-up the number of participants was SENSE Theatre N = 21 and Waitlist Control N = 22. Two participants in SENSE Theatre had missing data.

The SRS is a standardized measure of social competence self-administered by participants pertaining to behaviors characteristic of adults with ASD. T-scores range from scores of 38 to 90 with a mean of 50 and a standard deviation of 10. Higher scores reflect greater impairment. T-scores were used in the analyses. A decrease in scores from pretest to posttest or follow-up suggests a better outcome.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=22 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=24 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Change in Social Responsiveness Scale - Self (SRS)
Posttest (Week 11)
63.23 T Scores
Standard Deviation 9.107
67.50 T Scores
Standard Deviation 10.338
Change in Social Responsiveness Scale - Self (SRS)
Follow-up (Week 21)
62.76 T Scores
Standard Deviation 10.183
65.77 T Scores
Standard Deviation 8.815

PRIMARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. Two participants in Waitlist Control had missing data. For follow-up the number of participants was SENSE Theatre N = 20 and Waitlist Control N = 21. Three participants in SENSE Theatre and one in Waitlist Control had missing data.

The SRS is a standardized measure of social competence administered by care-givers pertaining to behaviors characteristic of adults with ASD. T-scores range from scores of 38 to 90 with a mean of 50 and standard deviation of 10. Higher scores reflect greater impairment. T-scores were used in analyses. Decrease in scores from Pretest to Posttest or follow-up suggest better outcome.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=22 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Change in Social Responsiveness Scale - Other (SRS)
Posttest (Week 11)
65.52 T Scores
Standard Deviation 9.853
66.23 T Scores
Standard Deviation 7.211
Change in Social Responsiveness Scale - Other (SRS)
Follow-up (Week 21)
63.95 T Scores
Standard Deviation 9.242
64.90 T Scores
Standard Deviation 8.282

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. One participant in SENSE Theatre had missing data. For follow-up the number of participants was SENSE Theatre N = 22 and Waitlist Control N = 21. One participant in SENSE Theatre and one participant in Waitlist Control had missing data.

A standardized measure of face memory with 72 items. Total raw score ranges from 0-72. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=22 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=24 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Cambridge Face Memory Test
Posttest (Week 11)
47.5 Raw score
Standard Deviation 10.796
45.75 Raw score
Standard Deviation 8.936
Cambridge Face Memory Test
Follow-up (Week 21)
47.68 Raw score
Standard Deviation 13.375
49.24 Raw score
Standard Deviation 9.060

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. For follow-up the number of participants was SENSE Theatre N = 23 and Waitlist Control N = 22.

A standardized measure of face memory in which the participant is exposed to 24 faces in which they must remember amidst an array of 48 faces presented after a 30-minute delay. Raw scores range from 0-48 and are converted to age-adjusted scaled scores ranging from 1 to 19 (Mean of 10 and standard deviation of 3). Higher scaled scores reflect better delayed face memory. Scaled scores were used for analyses.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=24 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Wechsler Memory Scale Face Memory Delay Test
Posttest (Week 11)
8.35 units on a scale
Standard Deviation 3.242
7.88 units on a scale
Standard Deviation 2.740
Wechsler Memory Scale Face Memory Delay Test
Follow-up (Week 21)
8.35 units on a scale
Standard Deviation 4.052
8.05 units on a scale
Standard Deviation 3.184

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. For follow-up the number of participants was SENSE Theatre N = 23 and Waitlist Control N = 22.

A standardized measure of face memory in which the participant is exposed to 24 faces in which they must remember amidst an array of 48 faces presented immediately. Raw scores range from 0-48 and are converted to age-adjusted scaled scores ranging from 1 to 19 (Mean of 10 and standard deviation of 3). Higher scaled scores reflect better face memory. Scaled scores were used for analyses.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=24 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Wechsler Memory Scale Face Memory Test
Posttest (Week 11)
8.13 units on a scale
Standard Deviation 3.507
7.67 units on a scale
Standard Deviation 2.914
Wechsler Memory Scale Face Memory Test
Follow-up (Week 21)
8.17 units on a scale
Standard Deviation 3.927
8.50 units on a scale
Standard Deviation 2.972

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. For follow-up the number of participants was SENSE Theatre N = 21 and Waitlist Control N = 21. Two participants in SENSE Theatre and one participant in Waitlist Control had missing data.

The ABAS measures adaptive living skills, completed via self-administration, using a Standardized Scale in which in which scores ranging from \~70 to \~120, with 85 to 115 reflecting the broad average range. Lower scores represent greater impairment.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=24 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Adaptive Behavior Assessment System (ABAS) - Self-Report Global Adaptive Composite
Posttest (Week 11)
89.04 Standard Score
Standard Deviation 16.328
85.83 Standard Score
Standard Deviation 19.175
Adaptive Behavior Assessment System (ABAS) - Self-Report Global Adaptive Composite
Follow-up (Week 21)
88.57 Standard Score
Standard Deviation 12.651
87.14 Standard Score
Standard Deviation 15.907

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. Two participants in Waitlist Control had missing data. For follow-up the number of participants was SENSE Theatre N = 20 and Waitlist Control N = 21. Three participants in SENSE Theatre and one participant in Waitlist Control had missing data.

The ABAS measures adaptive living skills, completed by a caregiver or partner, using a Standardized Scale in which scores ranging from \~70 to \~120, with 85 to 115 reflecting the broad average range. Lower scores represent greater impairment.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=22 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
Adaptive Behavior Assessment System (ABAS) - Other-Report Global Adaptive Composite
Posttest (Week 11)
76.61 Standard Score
Standard Deviation 13.313
79.73 Standard Score
Standard Deviation 15.761
Adaptive Behavior Assessment System (ABAS) - Other-Report Global Adaptive Composite
Follow-up (Week 21)
77.20 Standard Score
Standard Deviation 11.372
78.90 Standard Score
Standard Deviation 16.435

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. For follow-up the number of participants was SENSE Theatre N = 23 and Waitlist Control N = 22.

The STAI is a measure of current (State) and enduring (Trait) anxiety that is completed by the participant. There are 20 items for each domain on a 4-point scale (1 = Almost Never, 4 = Almost Always). Scores range from 20 to 80, with higher scores reflecting greater anxiety.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=24 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
State-Trait Anxiety Inventory (STAI) Scale
State Posttest (Week 11)
39.13 Raw score
Standard Deviation 8.498
42.42 Raw score
Standard Deviation 12.058
State-Trait Anxiety Inventory (STAI) Scale
Trait Posttest (Week 11)
42.43 Raw score
Standard Deviation 9.539
48.13 Raw score
Standard Deviation 4.266
State-Trait Anxiety Inventory (STAI) Scale
State Follow-up (Week 21)
39.57 Raw score
Standard Deviation 10.854
41.00 Raw score
Standard Deviation 12.585
State-Trait Anxiety Inventory (STAI) Scale
Trait Follow-up (Week 21)
42.83 Raw score
Standard Deviation 9.731
47.86 Raw score
Standard Deviation 13.892

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. One participant in Waitlist Control had missing data. For follow-up the number of participants was SENSE Theatre N = 21 and Waitlist Control N = 22. Two participants in SENSE Theatre had missing data.

The ASR is a 126-item self-report questionnaire assessing aspects of emotional health. T scores range from 40 to 100 with a mean of 50 and a standard deviation of 10. The primary variables of interest were Depressive Problems and Anxiety Problems. Higher scores indicate more depressive or anxiety problems. A T score of 70 or higher is considered clinically significant.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=23 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
The Adult Self Report (ASR)
Depression problems Posttest (Week 11)
60.83 T Scores
Standard Deviation 10.347
63.39 T Scores
Standard Deviation 11.555
The Adult Self Report (ASR)
Anxiety Problems Posttest (Week 11)
53.83 T Scores
Standard Deviation 6.485
59.00 T Scores
Standard Deviation 8.650
The Adult Self Report (ASR)
Depression problems Follow-up (Week 21)
59.86 T Scores
Standard Deviation 10.744
62.68 T Scores
Standard Deviation 10.191
The Adult Self Report (ASR)
Anxiety problems Follow-up (Week 21)
56.19 T Scores
Standard Deviation 8.744
60.27 T Scores
Standard Deviation 10.161

SECONDARY outcome

Timeframe: Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21)

Population: Number of participants analyzed at posttest. Two participants in Waitlist Control had missing data. For follow-up the number of participants was SENSE Theatre N = 20 and Waitlist Control N = 21. Three participants in SENSE Theatre and one participant in Waitlist Control had missing data.

The ABCL is a 126-item caregiver-report questionnaire assessing aspects of emotional health. T scores range from 40 to 100 with a mean of 50 and a standard deviation of 10. The primary variables of interest were Depressive Problems and Anxiety Problems. Higher scores indicate more depressive or anxiety problems. A T score of 70 or higher is considered clinically significant.

Outcome measures

Outcome measures
Measure
SENSE Theatre
n=23 Participants
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior. SENSE Theatre: A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Waitlist Control Group
n=22 Participants
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
The Adult Behavior Checklist (ABCL)
Depression problems posttest (week 11)
61.26 T Scores
Standard Deviation 9.314
63.91 T Scores
Standard Deviation 10.099
The Adult Behavior Checklist (ABCL)
Anxiety problems posttest (week 11)
58.13 T Scores
Standard Deviation 9.411
60.36 T Scores
Standard Deviation 8.644
The Adult Behavior Checklist (ABCL)
Depression problems follow-up (week 21)
60.25 T Scores
Standard Deviation 9.962
64.00 T Scores
Standard Deviation 9.327
The Adult Behavior Checklist (ABCL)
Anxiety problems follow-up (week 21)
58.90 T Scores
Standard Deviation 9.978
61.43 T Scores
Standard Deviation 8.483

Adverse Events

SENSE Theatre

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Waitlist Control 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

Blythe Corbett, Ph.D.

Vanderbilt University Medical Center

Phone: (615) 936-0280

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place