Trial Outcomes & Findings for Investigating Social Competence in Youth With Autism (NCT NCT03368001)
NCT ID: NCT03368001
Last Updated: 2024-10-08
Results Overview
A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
318 participants
Primary outcome timeframe
Change from baseline to end of treatment (10 weeks).
Results posted on
2024-10-08
Participant Flow
Excluded (n = 28) Not meeting inclusion criteria (n = 22) No longer interested (n = 2) Refused to participate (n = 3) Unable to contact (n = 1)
Participant milestones
| Measure |
SENSE Theatre
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
|---|---|---|
|
Allocation
STARTED
|
144
|
146
|
|
Allocation
COMPLETED
|
120
|
112
|
|
Allocation
NOT COMPLETED
|
24
|
34
|
|
Posttest
STARTED
|
114
|
93
|
|
Posttest
COMPLETED
|
101
|
63
|
|
Posttest
NOT COMPLETED
|
13
|
30
|
|
Follow-up
STARTED
|
101
|
63
|
|
Follow-up
COMPLETED
|
95
|
60
|
|
Follow-up
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
SENSE Theatre
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
|---|---|---|
|
Allocation
Lost to Pretest
|
16
|
25
|
|
Allocation
Completed Pretest but 0 Intervention sessions
|
8
|
9
|
|
Posttest
Lost to Posttest
|
7
|
11
|
|
Posttest
Discontinued Intervention
|
6
|
19
|
|
Follow-up
Lost to Follow-up
|
6
|
3
|
Baseline Characteristics
Investigating Social Competence in Youth With Autism
Baseline characteristics by cohort
| Measure |
SENSE Theatre
n=114 Participants
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
n=93 Participants
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.62 years
STANDARD_DEVIATION 1.86 • n=5 Participants
|
12.62 years
STANDARD_DEVIATION 1.98 • n=7 Participants
|
12.62 years
STANDARD_DEVIATION 1.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
93 participants
n=7 Participants
|
207 participants
n=5 Participants
|
|
Wechsler Abbreviated Scale of Intelligence (WASI) II Full Scale Intelligence Quotient (IQ)
|
99.32 units on a scale
STANDARD_DEVIATION 19.25 • n=5 Participants
|
97.28 units on a scale
STANDARD_DEVIATION 17.99 • n=7 Participants
|
98.40 units on a scale
STANDARD_DEVIATION 18.68 • n=5 Participants
|
|
Autism Diagnostic Observation Schedule (ADOS) 2 Severity Scale
|
7.25 units on a scale
STANDARD_DEVIATION 1.94 • n=5 Participants
|
7.52 units on a scale
STANDARD_DEVIATION 1.91 • n=7 Participants
|
7.37 units on a scale
STANDARD_DEVIATION 1.92 • n=5 Participants
|
|
IFM Index
|
-.31 µV
STANDARD_DEVIATION 3.99 • n=5 Participants
|
-.17 µV
STANDARD_DEVIATION 3.27 • n=7 Participants
|
-0.25 µV
STANDARD_DEVIATION 3.68 • n=5 Participants
|
|
CASS Interested
CASS-I Vocal Expressiveness
|
4.30 units on a scale
STANDARD_DEVIATION 1.70 • n=5 Participants
|
4.32 units on a scale
STANDARD_DEVIATION 1.56 • n=7 Participants
|
4.31 units on a scale
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
CASS Interested
CASS-I Quality of Rapport
|
4.16 units on a scale
STANDARD_DEVIATION 1.39 • n=5 Participants
|
4.10 units on a scale
STANDARD_DEVIATION 1.21 • n=7 Participants
|
4.13 units on a scale
STANDARD_DEVIATION 1.31 • n=5 Participants
|
|
CASS Interested
CASS-I Social Anxiety
|
3.61 units on a scale
STANDARD_DEVIATION 1.61 • n=5 Participants
|
3.99 units on a scale
STANDARD_DEVIATION 1.45 • n=7 Participants
|
3.78 units on a scale
STANDARD_DEVIATION 1.55 • n=5 Participants
|
|
SRS-2 Communication
|
32.33 T-Score
STANDARD_DEVIATION 8.98 • n=5 Participants
|
32.28 T-Score
STANDARD_DEVIATION 9.58 • n=7 Participants
|
32.31 T-Score
STANDARD_DEVIATION 9.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to end of treatment (10 weeks).Population: Unfortunately, collection of the data was not completed and improperly administered at one of the key study sites, rendering the data invalid.
A measure of face memory following a delay. Possible score ranges from a scaled score of 1-19 with high scores reflecting better face memory.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to end of treatment (10 weeks) and at two-month follow-up.Population: Number of participants analyzed at posttest. For follow-up the number of participants was SENSE Theatre N =101 and Tackling Teenage N = 79.
The IFM involves passive viewing of novel faces one of which repeats. The dependent measure is the difference in ERP amplitude of 250-500 ms time window between the repeated and single face presentation. Positive values indicate better face memory.
Outcome measures
| Measure |
SENSE Theatre
n=107 Participants
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
n=82 Participants
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
|---|---|---|
|
Incidental Face Memory (IFM) Event-Related Potential (ERP) Task
IFM Posttest
|
.74 µV
Standard Deviation 2.39
|
-.22 µV
Standard Deviation 2.37
|
|
Incidental Face Memory (IFM) Event-Related Potential (ERP) Task
IFM Follow-up
|
.12 µV
Standard Deviation 3.05
|
.01 µV
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Baseline, post-treatment (10 weeks), and two-month follow-up.Population: Number of participants analyzed at posttest. Number of participants analyzed at two-month follow-up SENSE Theatre N = 101, Tackling Teenage N = 79.
The SRS is a measure of social competence that is administered by parents pertaining to behaviors characteristic of children with autism. Raw scores on the Social Communication domain range from 0 - 66. Higher scores indicate more impairment. Raw scores were used in the analyses. A decrease in scores from pre- to post-treatment suggests a better outcome.
Outcome measures
| Measure |
SENSE Theatre
n=107 Participants
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
n=82 Participants
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
|---|---|---|
|
Social Responsiveness Scale (SRS) Communication
SRS Communication Posttest
|
30.33 Raw scores.
Standard Deviation 9.32
|
30.22 Raw scores.
Standard Deviation 9.43
|
|
Social Responsiveness Scale (SRS) Communication
SRS Communication Follow-up
|
29.74 Raw scores.
Standard Deviation 9.23
|
29.82 Raw scores.
Standard Deviation 9.86
|
SECONDARY outcome
Timeframe: Baseline, post-treatment (10 weeks), and two-month follow-up.Population: Number of participants analyzed at posttest. One participant in Tackling Teenage had missing data. The number of participants analyzed at two-month follow-up SENSE Theatre N=99, Tackling Teenage N=78. Two participants in SENSE Theatre and one in Tackling Teenage had missing data.
The ABAS is a parental rating scale pertaining to various adaptive behaviors in a child, such as social and communication skills. Standard scores for the subscales range from 1 to 19. Higher scores reflect better skills in each domain. The primary variable of interest was the Communication subscale, ranging from 1 to 19 with higher scores reflecting better communication skills.
Outcome measures
| Measure |
SENSE Theatre
n=107 Participants
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
n=81 Participants
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
|---|---|---|
|
Adaptive Behavior Scales for Children (ABAS)
ABAS Communication Posttest
|
6.50 units on a scale
Standard Deviation 2.076
|
6.44 units on a scale
Standard Deviation 2.185
|
|
Adaptive Behavior Scales for Children (ABAS)
ABAS Communication Followup
|
7.32 units on a scale
Standard Deviation 5.421
|
6.82 units on a scale
Standard Deviation 1.959
|
SECONDARY outcome
Timeframe: Baseline, post-treatment (10 weeks), and two-month follow-up.Population: Number of participants analyzed for Posttest. Number of participants analyzed for Follow-up SENSE Theatre N = 101, Tackling Teenage N = 79.
The CASS is an observational measure of social interaction skills with two similar age peers. There are two conditions which include an Interested Condition and a Bored Condition. The behaviors will be coded based on raw scores from 1 to 7 with 7 reflecting better ability. Only the Interested Condition was analyzed.
Outcome measures
| Measure |
SENSE Theatre
n=107 Participants
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
n=82 Participants
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
|---|---|---|
|
Contextual Assessment of Social Skills (CASS) Interested
Vocal Expressiveness Posttest
|
4.29 units on a scale
Standard Deviation 1.59
|
3.94 units on a scale
Standard Deviation 1.76
|
|
Contextual Assessment of Social Skills (CASS) Interested
Social Anxiety Follow-up
|
3.90 units on a scale
Standard Deviation 1.40
|
3.77 units on a scale
Standard Deviation 1.58
|
|
Contextual Assessment of Social Skills (CASS) Interested
Vocal Expressiveness Follow-up
|
4.20 units on a scale
Standard Deviation 1.53
|
4.05 units on a scale
Standard Deviation 1.75
|
|
Contextual Assessment of Social Skills (CASS) Interested
Quality of Rapport Posttest
|
4.14 units on a scale
Standard Deviation 1.39
|
4.23 units on a scale
Standard Deviation 1.66
|
|
Contextual Assessment of Social Skills (CASS) Interested
Quality of Rapport Follow-up
|
4.26 units on a scale
Standard Deviation 1.29
|
4.22 units on a scale
Standard Deviation 1.49
|
|
Contextual Assessment of Social Skills (CASS) Interested
Social Anxiety Posttest
|
4.19 units on a scale
Standard Deviation 1.53
|
4.03 units on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline, post-treatment (10 weeks), and two-month follow-up.Population: Number of participants analyzed at posttest. One participant in Tackling Teenage and two participants in SENSE Theatre had missing data. The number of participants analyzed at two-month follow-up SENSE Theatre N=98, Tackling Teenage N=78. Three participants in SENSE Theatre and one in Tackling Teenage had missing data.
The CBCL is a parent report measure of a variety of symptom domains relevant for children with autism and related neurodevelopment disorders. T scores range from 40 to 100 with a mean of 50 and a deviation of 10. Primary variable of interest was Social Problems. Higher scores indicate more social problems. T scores of 64 or higher are considered clinically significant.
Outcome measures
| Measure |
SENSE Theatre
n=105 Participants
SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
SENSE Theatre: SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
|
Tackling Teenage Together
n=80 Participants
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Tackling Teenage Together: The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
|
|---|---|---|
|
Child Behavior Checklist (CBCL)
CBCL Social Problems Followup
|
64.14 T score
Standard Deviation 8.445
|
64.65 T score
Standard Deviation 8.357
|
|
Child Behavior Checklist (CBCL)
CBCL Social Problems Posttest
|
64.18 T score
Standard Deviation 7.644
|
65.41 T score
Standard Deviation 8.422
|
Adverse Events
SENSE Theatre
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tackling Teenage Together
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
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place