Autism Spectrum Disorder
Conditions
Keywords
autism, social competence, theatre
Brief summary
SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. The intervention has the potential to enhance social cognition and behavior in adults with autism spectrum disorder.
Detailed description
Autism spectrum disorder (ASD) is characterized by primary impairment in social competence. Effects of current psychosocial interventions often fail to maintain or generalize and few employ rigorous experimental methods. Our treatment, SENSE Theatre®, combines several well-documented, effective behavioral strategies, such as the inclusion of trained peer models, theatre play techniques involving predictable (i.e., scripted) and flexible (improvised) role-play, and repeated performance of newly learned skills resulting in greater automaticity of behavior. 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 an RCT of SENSE Theatre with a sample of approximately 40 adult participants with ASD (18 to 35 years) randomized to experimental (EXP; N = 20) and a wait list control group (WLC; N = 20) in two separate cohorts. The RCT will assess target engagement of memory for faces and functional change in social interaction with peers using examiners blind to study treatment group assignment. The significance and size of treatment effects on these cognitive and behavioral outcomes will be measured using ANOVA and linear mixed models. 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 adults with ASD.
Interventions
BEHAVIORALSENSE Theatre
A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Sponsors
Vanderbilt University Medical Center
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
ASD Inclusion Criteria: * diagnosed with ASD based on DSM-V criteria (APA, 2013), by a psychologist, pediatrician or psychiatrist with expertise in ASD will be enrolled. ASD diagnosis will be corroborated by the Autism Diagnostic Observation Schedule (ADOS-2) (Lord, 2012). * Only adults not currently supported by educational opportunities will be enrolled. * Participants must have a full-scale IQ \> or = 70 (WASI; (Wechsler, 2011)) ASD
Exclusion criteria
* Adults with intellectual impairment (WASI; (Wechsler, 2011) score \< 70. * Participants with current, frequent and uncontrolled aggression toward other persons or property in the past 6 months will be excluded based on phone screening and questions from the Adult Behavior Checklist (Achenbach, 2001) (e.g., "Physically attacks people"). * Participants with evidence of suicidality based on care-provider report, self-report, or clinical interview (i.e., endorsement of suicidal ideation in the past month and/or suicidal behavior in the past three months on the Columbia Suicide Severity Rating Scale (Posner, 2011), * Previous SENSE Theatre® participants will be excluded. Care-giver Inclusion Criteria: * must be at least 18 years of age * must be a parent, close relative, or spouse of the adult participant with ASD. * must be able to provide current and historical observations of the functioning of the participant with ASD. * must live in close proximity to and have frequent contact with the participant with ASD. Care-giver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Incidental Face Memory | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| Change in Contextual Assessment of Social Skills | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| Change in Social Responsiveness Scale - Self (SRS) | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| Change in Social Responsiveness Scale - Other (SRS) | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cambridge Face Memory Test | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| Wechsler Memory Scale Face Memory Delay Test | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| Wechsler Memory Scale Face Memory Test | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| Adaptive Behavior Assessment System (ABAS) - Self-Report Global Adaptive Composite | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| Adaptive Behavior Assessment System (ABAS) - Other-Report Global Adaptive Composite | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| State-Trait Anxiety Inventory (STAI) Scale | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| The Adult Self Report (ASR) | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
| The Adult Behavior Checklist (ABCL) | Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBlythe A Corbett, Ph.D.
Vanderbilt University Medical Center
Participant flow
Pre-assignment details
Excluded (N=8). Not meeting inclusion criteria (N=5), Transportation issues (N=1), and unknown/reason not provided (N=2).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Waitlist Control Group This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention. | 35 |
| Total | 64 |
Baseline characteristics
| Characteristic | SENSE Theatre | Total | Waitlist Control Group |
|---|---|---|---|
| Age, Continuous | 24.48 years STANDARD_DEVIATION 4.92 | 24.38 years STANDARD_DEVIATION 5.49 | 24.30 years STANDARD_DEVIATION 5.97 |
| Autism Diagnostic Observation Schedule, 2nd Edition, Module 4 | 7.34 units on a scale STANDARD_DEVIATION 1.86 | 7.43 units on a scale STANDARD_DEVIATION 1.73 | 7.51 units on a scale STANDARD_DEVIATION 1.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 61 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 8 Participants | 4 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 | 22 Participants | 48 Participants | 26 Participants |
| Region of Enrollment United States | 29 participants | 64 participants | 35 participants |
| Sex: Female, Male Female | 14 Participants | 31 Participants | 17 Participants |
| Sex: Female, Male Male | 15 Participants | 33 Participants | 18 Participants |
| Wechsler Abbreviated Scale of Intelligence, 2nd Edition | 102.45 units on a scale STANDARD_DEVIATION 17.21 | 102.78 units on a scale STANDARD_DEVIATION 20.31 | 103.06 units on a scale STANDARD_DEVIATION 22.86 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 35 |
| other Total, other adverse events | 0 / 29 | 0 / 35 |
| serious Total, serious adverse events | 0 / 29 | 0 / 35 |
Outcome results
Primary
Change in Contextual Assessment of Social Skills
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.
Time frame: Pretest, Posttest (Week 11), Follow-up (Week 21)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Change in Contextual Assessment of Social Skills | Vocal Expressiveness Posttest (Week 11) | 4.82 units on a scale | Standard Deviation 1.708 |
| SENSE Theatre | Change in Contextual Assessment of Social Skills | Quality of Rappport Posttest (Week 11) | 5.43 units on a scale | Standard Deviation 1.409 |
| SENSE Theatre | Change in Contextual Assessment of Social Skills | Vocal Expressiveness Follow-up (Week 21) | 4.30 units on a scale | Standard Deviation 1.917 |
| SENSE Theatre | Change in Contextual Assessment of Social Skills | Quality of Rapport Follow-up (Week 21) | 5.00 units on a scale | Standard Deviation 1.168 |
| Waitlist Control Group | Change in Contextual Assessment of Social Skills | Quality of Rapport Follow-up (Week 21) | 4.85 units on a scale | Standard Deviation 1.226 |
| Waitlist Control Group | Change in Contextual Assessment of Social Skills | Vocal Expressiveness Posttest (Week 11) | 4.52 units on a scale | Standard Deviation 1.648 |
| Waitlist Control Group | Change in Contextual Assessment of Social Skills | Vocal Expressiveness Follow-up (Week 21) | 4.26 units on a scale | Standard Deviation 1.485 |
| Waitlist Control Group | Change in Contextual Assessment of Social Skills | Quality of Rappport Posttest (Week 11) | 5.13 units on a scale | Standard Deviation 1.262 |
p-value: 0.932ANCOVA
p-value: 0.221ANCOVA
p-value: 0.873ANCOVA
p-value: 0.512ANCOVA
Primary
Change in Incidental Face Memory
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.
Time frame: Pretest, Posttest (Week 11), Follow-up (Week 21)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Change in Incidental Face Memory | Posttest (Week 11) | 0.6588 microvolts | Standard Deviation 0.9006 |
| SENSE Theatre | Change in Incidental Face Memory | Follow-up (Week 21) | 0.469 microvolts | Standard Deviation 1.279 |
| Waitlist Control Group | Change in Incidental Face Memory | Posttest (Week 11) | -0.1604 microvolts | Standard Deviation 1.1751 |
| Waitlist Control Group | Change in Incidental Face Memory | Follow-up (Week 21) | -0.77 microvolts | Standard Deviation 1.869 |
p-value: 0.016ANCOVA
p-value: 0.288ANCOVA
Primary
Change in Social Responsiveness Scale - Other (SRS)
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 higher scores reflecting greater impairment. T-scores were used in analyses. Decrease in scores from Pretest to Posttest or follow-up suggest better outcome.
Time frame: Pretest, Posttest (Week 11), Follow-up (Week 21)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Change in Social Responsiveness Scale - Other (SRS) | Posttest (Week 11) | 65.52 units on a scale | Standard Deviation 9.853 |
| SENSE Theatre | Change in Social Responsiveness Scale - Other (SRS) | Follow-up (Week 21) | 63.95 units on a scale | Standard Deviation 9.242 |
| Waitlist Control Group | Change in Social Responsiveness Scale - Other (SRS) | Posttest (Week 11) | 66.23 units on a scale | Standard Deviation 7.211 |
| Waitlist Control Group | Change in Social Responsiveness Scale - Other (SRS) | Follow-up (Week 21) | 64.90 units on a scale | Standard Deviation 8.282 |
p-value: 0.917ANCOVA
p-value: 0.963ANCOVA
Primary
Change in Social Responsiveness Scale - Self (SRS)
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 higher scores reflecting greater impairment. T-scores were used in the analyses. A decrease in scores from pretest to posttest or follow-up suggests a better outcome.
Time frame: Pretest, Posttest (Week 11), Follow-up (Week 21)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SENSE Theatre | Change in Social Responsiveness Scale - Self (SRS) | Posttest (Week 11) | 63.23 units on a scale | Standard Deviation 9.107 |
| SENSE Theatre | Change in Social Responsiveness Scale - Self (SRS) | Follow-up (Week 21) | 62.76 units on a scale | Standard Deviation 10.183 |
| Waitlist Control Group | Change in Social Responsiveness Scale - Self (SRS) | Posttest (Week 11) | 67.50 units on a scale | Standard Deviation 10.338 |
| Waitlist Control Group | Change in Social Responsiveness Scale - Self (SRS) | Follow-up (Week 21) | 65.77 units on a scale | Standard Deviation 8.815 |
p-value: 0.05ANCOVA
p-value: 0.393ANCOVA
Secondary
Adaptive Behavior Assessment System (ABAS) - Parent-Report
The ABAS measures adaptive living skills using a Standardized Scale in which scores from 85 to 115 reflect the broad average range. Lower scores represent greater impairment.
Time frame: Pretest, Week 5, Week 11, two-month follow-up
Secondary
Adaptive Behavior Assessment System (ABAS) - Self-Report
The ABAS measures adaptive living skills using a Standardized Scale in which scores from 85 to 115 reflect the broad average range. Lower scores represent greater impairment.
Time frame: Pretest, Week 5, Week 11, two-month follow-up
Secondary
Cambridge Face Memory Test
A standardized measure of face memory with 72 items. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.
Time frame: Pretest, Week 11, two-month follow-up
Secondary
State-Trait Anxiety Inventory (STAI) Scale
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) and higher scores reflect greater anxiety.
Time frame: Pretest, Week 11, two-month follow-up
Secondary
The Adult Behavior Checklist (ABCL)
The ABCL is the care-giver-report version of the Achenbach system that covers emotional health. We will focus on the anxiety and depressive subscales. T-scores range from 40 to 100 with higher scores representing more impairment.
Time frame: Pretest, Week 5, Week 11, two-month follow-up
Secondary
The Adult Self Report (ASR)
The ASR is the self-report of the Achenbach empirically system which covers emotional health. We will focus on the anxiety and depressive subscales. T-scores range from 40 to 100 with higher scores representing more impairment.
Time frame: Pretest, Week 5, Week 11, two-month follow-up
Secondary
Wechsler Memory Scale Face Memory Delay Test
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 and after a 30-minute delay. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.
Time frame: Pretest, Week 11, two-month follow-up
Secondary
Wechsler Memory Scale Face Memory Test
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 and after a 30-minute delay. Any increase in the raw score pertaining to the number of faces identified constitutes an increase in face memory.
Time frame: Pretest, Week 11, two-month follow-up