Autism Spectrum Disorder
Conditions
Keywords
Autism
Brief summary
Our treatment, SENSE Theatre, combines several well-documented, effective behavioral strategies and theatre techniques. The proposed project will extend previous findings showing improving improvement in memory for faces. The multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (ASD) randomly assigned to the experimental (SENSE Theatre) or an active control condition (Tackling Teenage Together).
Detailed description
Recent findings from a randomized control trial (RCT) show immediate between-group effects and evidence of target engagement on the hypothesized mechanism of action, memory for faces, which was evaluated by neuropsychological and event-related potential (ERP) measures. Moreover, the RCT demonstrated treatment effects on social communication skills that generalized to home and community settings. Finally, maintained treatment effects were observed on communication symptoms. The proposed project will extend these findings and provide a stronger test of efficacy using a multisite RCT of SENSE Theatre with a large sample of participants with ASD (8 to 16 years) randomized to an experimental and an active control group. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers. Thus, the overarching aim of the study is to determine whether detected changes in face memory and social interaction are due to the SENSE Theatre treatment and the extent to which these changes generalize and maintain. If predicted results occur, it will provide strong empirical support for a community-based treatment that has generalized effects on a set of core deficits that otherwise have life-long consequences for children and adolescents with ASD. 8/18/2021: Record was updated to delete the outcome measure Computer memory for faces as it was not included as a primary outcome variable in the Institutional Review Board (IRB) approved protocol dated 9/13/2017.
Interventions
BEHAVIORALSENSE 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).
BEHAVIORALTackling Teenage Together
The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children with high-functioning ASD (IQ \> or = to 70).
Exclusion criteria
* Children who evidence aggression toward other people.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed | Change from baseline to end of treatment (10 weeks). | 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. |
| Incidental Face Memory (IFM) Event-Related Potential (ERP) Task | Change from baseline to end of treatment (10 weeks) and at two-month follow-up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Responsiveness Scale (SRS) Communication | Baseline, post-treatment (10 weeks), and two-month follow-up. | 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. |
| Adaptive Behavior Scales for Children (ABAS) | Baseline, post-treatment (10 weeks), and two-month follow-up. | 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. |
| Contextual Assessment of Social Skills (CASS) Interested | Baseline, post-treatment (10 weeks), and two-month follow-up. | 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. |
| Child Behavior Checklist (CBCL) | Baseline, post-treatment (10 weeks), and two-month follow-up. | 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. |
Countries
United States
Participant flow
Pre-assignment details
Excluded (n = 28) Not meeting inclusion criteria (n = 22) No longer interested (n = 2) Refused to participate (n = 3) Unable to contact (n = 1)
Participants by arm
| Arm | Count |
|---|---|
| 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). | 114 |
| 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. | 93 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Allocation | Completed Pretest but 0 Intervention sessions | 8 | 9 |
| Allocation | Lost to Pretest | 16 | 25 |
| Follow-up | Lost to Follow-up | 6 | 3 |
| Posttest | Discontinued Intervention | 6 | 19 |
| Posttest | Lost to Posttest | 7 | 11 |
Baseline characteristics
| Characteristic | SENSE Theatre | Tackling Teenage Together | Total |
|---|---|---|---|
| Age, Continuous | 12.62 years STANDARD_DEVIATION 1.86 | 12.62 years STANDARD_DEVIATION 1.98 | 12.62 years STANDARD_DEVIATION 1.91 |
| Autism Diagnostic Observation Schedule (ADOS) 2 Severity Scale | 7.25 units on a scale STANDARD_DEVIATION 1.94 | 7.52 units on a scale STANDARD_DEVIATION 1.91 | 7.37 units on a scale STANDARD_DEVIATION 1.92 |
| CASS Interested CASS-I Quality of Rapport | 4.16 units on a scale STANDARD_DEVIATION 1.39 | 4.10 units on a scale STANDARD_DEVIATION 1.21 | 4.13 units on a scale STANDARD_DEVIATION 1.31 |
| CASS Interested CASS-I Social Anxiety | 3.61 units on a scale STANDARD_DEVIATION 1.61 | 3.99 units on a scale STANDARD_DEVIATION 1.45 | 3.78 units on a scale STANDARD_DEVIATION 1.55 |
| CASS Interested CASS-I Vocal Expressiveness | 4.30 units on a scale STANDARD_DEVIATION 1.7 | 4.32 units on a scale STANDARD_DEVIATION 1.56 | 4.31 units on a scale STANDARD_DEVIATION 1.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 87 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| IFM Index | -.31 µV STANDARD_DEVIATION 3.99 | -.17 µV STANDARD_DEVIATION 3.27 | -0.25 µV STANDARD_DEVIATION 3.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 9 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 8 Participants | 15 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 | 89 Participants | 74 Participants | 163 Participants |
| Region of Enrollment United States | 114 participants | 93 participants | 207 participants |
| Sex: Female, Male Female | 31 Participants | 29 Participants | 60 Participants |
| Sex: Female, Male Male | 83 Participants | 64 Participants | 147 Participants |
| SRS-2 Communication | 32.33 T-Score STANDARD_DEVIATION 8.98 | 32.28 T-Score STANDARD_DEVIATION 9.58 | 32.31 T-Score STANDARD_DEVIATION 9.23 |
| Wechsler Abbreviated Scale of Intelligence (WASI) II Full Scale Intelligence Quotient (IQ) | 99.32 units on a scale STANDARD_DEVIATION 19.25 | 97.28 units on a scale STANDARD_DEVIATION 17.99 | 98.40 units on a scale STANDARD_DEVIATION 18.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 93 |
| other Total, other adverse events | 0 / 114 | 0 / 93 |
| serious Total, serious adverse events | 0 / 114 | 0 / 93 |
Outcome results
Primary
Developmental Neuropsychological Assessment (NEPSY) Memory for Faces Delayed
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.
Time frame: 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.
Primary
Incidental Face Memory (IFM) Event-Related Potential (ERP) Task
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Incidental Face Memory (IFM) Event-Related Potential (ERP) Task | IFM Follow-up | .12 µV | Standard Deviation 3.05 |
| SENSE Theatre | Incidental Face Memory (IFM) Event-Related Potential (ERP) Task | IFM Posttest | .74 µV | Standard Deviation 2.39 |
| Tackling Teenage Together | Incidental Face Memory (IFM) Event-Related Potential (ERP) Task | IFM Posttest | -.22 µV | Standard Deviation 2.37 |
| Tackling Teenage Together | Incidental Face Memory (IFM) Event-Related Potential (ERP) Task | IFM Follow-up | .01 µV | Standard Deviation 3.27 |
Comparison: Population models were specified using parameter values derived from past research in tandem with minimal expected effect sizes for the effects of most interest. These models were used to generate 5000 samples for a given N, the models were fit to each sample, and the significance (or not) of key effects was noted. This process was repeated until the target power of at least .80 was reached indicating with 216 participants we would have .82 power.p-value: 0.039Structural Equation Modeling
Comparison: The indirect effect of SENSE Theatre® vs. TTT through post-test IFM on follow-up Vocal Expressiveness. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.p-value: <0.0590% CI: [0.014, 0.118]Structural Equation Model (SEM)
Comparison: The partially standardized indirect effect of treatment on follow-up Quality of Rapport through posttest Incidental Face Memory. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag (pretest to posttest) and baseline mediator, and controlled the outcome for individual differences in lag (pretest to follow-up) and baseline outcome.p-value: <0.0590% CI: [0.002, 0.087]Structural Equation Model (SEM)
Comparison: The partially standardized indirect effect of treatment on follow-up Social Anxiety through posttest IFM. Adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.p-value: >0.0590% CI: [-0.015, 0.059]Structural Equation Model (SEM)
Comparison: The partially standardized indirect effect of treatment on follow-up SRS Communication. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.p-value: >0.0590% CI: [-0.054, 0.061]Structural Equation Model (SEM)
Secondary
Adaptive Behavior Scales for Children (ABAS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Adaptive Behavior Scales for Children (ABAS) | ABAS Communication Posttest | 6.50 units on a scale | Standard Deviation 2.076 |
| SENSE Theatre | Adaptive Behavior Scales for Children (ABAS) | ABAS Communication Followup | 7.32 units on a scale | Standard Deviation 5.421 |
| Tackling Teenage Together | Adaptive Behavior Scales for Children (ABAS) | ABAS Communication Posttest | 6.44 units on a scale | Standard Deviation 2.185 |
| Tackling Teenage Together | Adaptive Behavior Scales for Children (ABAS) | ABAS Communication Followup | 6.82 units on a scale | Standard Deviation 1.959 |
p-value: 0.704ANCOVA
p-value: 0.406ANCOVA
Secondary
Child Behavior Checklist (CBCL)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Child Behavior Checklist (CBCL) | CBCL Social Problems Posttest | 64.18 T score | Standard Deviation 7.644 |
| SENSE Theatre | Child Behavior Checklist (CBCL) | CBCL Social Problems Followup | 64.14 T score | Standard Deviation 8.445 |
| Tackling Teenage Together | Child Behavior Checklist (CBCL) | CBCL Social Problems Posttest | 65.41 T score | Standard Deviation 8.422 |
| Tackling Teenage Together | Child Behavior Checklist (CBCL) | CBCL Social Problems Followup | 64.65 T score | Standard Deviation 8.357 |
p-value: 0.169ANCOVA
p-value: 0.555ANCOVA
Secondary
Contextual Assessment of Social Skills (CASS) Interested
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Contextual Assessment of Social Skills (CASS) Interested | Vocal Expressiveness Posttest | 4.29 units on a scale | Standard Deviation 1.59 |
| SENSE Theatre | Contextual Assessment of Social Skills (CASS) Interested | Vocal Expressiveness Follow-up | 4.20 units on a scale | Standard Deviation 1.53 |
| SENSE Theatre | Contextual Assessment of Social Skills (CASS) Interested | Quality of Rapport Posttest | 4.14 units on a scale | Standard Deviation 1.39 |
| SENSE Theatre | Contextual Assessment of Social Skills (CASS) Interested | Quality of Rapport Follow-up | 4.26 units on a scale | Standard Deviation 1.29 |
| SENSE Theatre | Contextual Assessment of Social Skills (CASS) Interested | Social Anxiety Posttest | 4.19 units on a scale | Standard Deviation 1.53 |
| SENSE Theatre | Contextual Assessment of Social Skills (CASS) Interested | Social Anxiety Follow-up | 3.90 units on a scale | Standard Deviation 1.4 |
| Tackling Teenage Together | Contextual Assessment of Social Skills (CASS) Interested | Social Anxiety Posttest | 4.03 units on a scale | Standard Deviation 1.59 |
| Tackling Teenage Together | Contextual Assessment of Social Skills (CASS) Interested | Vocal Expressiveness Posttest | 3.94 units on a scale | Standard Deviation 1.76 |
| Tackling Teenage Together | Contextual Assessment of Social Skills (CASS) Interested | Quality of Rapport Follow-up | 4.22 units on a scale | Standard Deviation 1.49 |
| Tackling Teenage Together | Contextual Assessment of Social Skills (CASS) Interested | Vocal Expressiveness Follow-up | 4.05 units on a scale | Standard Deviation 1.75 |
| Tackling Teenage Together | Contextual Assessment of Social Skills (CASS) Interested | Social Anxiety Follow-up | 3.77 units on a scale | Standard Deviation 1.58 |
| Tackling Teenage Together | Contextual Assessment of Social Skills (CASS) Interested | Quality of Rapport Posttest | 4.23 units on a scale | Standard Deviation 1.66 |
Comparison: Vocal Expressiveness Posttest.p-value: 0.217Structural Equation Modeling
Comparison: Quality of Rapport Posttest.p-value: 0.448Structural Equation Modeling
Comparison: Social Anxiety Posttest.p-value: 0.15Structural Equation Modeling
Secondary
Social Responsiveness Scale (SRS) Communication
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Social Responsiveness Scale (SRS) Communication | SRS Communication Posttest | 30.33 Raw scores. | Standard Deviation 9.32 |
| SENSE Theatre | Social Responsiveness Scale (SRS) Communication | SRS Communication Follow-up | 29.74 Raw scores. | Standard Deviation 9.23 |
| Tackling Teenage Together | Social Responsiveness Scale (SRS) Communication | SRS Communication Posttest | 30.22 Raw scores. | Standard Deviation 9.43 |
| Tackling Teenage Together | Social Responsiveness Scale (SRS) Communication | SRS Communication Follow-up | 29.82 Raw scores. | Standard Deviation 9.86 |
p-value: 0.49Structural Equation Modeling