Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
NCT Number: NCT04349644
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.
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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37212, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
ASD Inclusion Criteria:
ASD Exclusion Criteria:
Care-giver Inclusion Criteria:
Care-giver Exclusion Criteria:
Confederates Inclusion Criteria:
Confederate Exclusion Criteria:
Peers Inclusion Criteria:
Peers Exclusion Criteria:
A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Vanderbilt University Medical Center
Other
Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT
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