Clinical trial NCT04349644: Enhancing Social Competence in Adults With Autism
Official title: Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
social competence
theatre
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-04-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Confederates Inclusion Criteria:

* must be at least 18 years of age
* typically developing individual with no neurodevelopmental disorder.
* must successfully complete training and demonstrate consistent administration of research protocols.

Confederate Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Peers Inclusion Criteria:

* must be at least 18 years of age
* typically developing individual with no neurodevelopmental disorder.
* must have an expressed interest in supporting young adults and adults with developmental disabilities or ASD
* must successfully complete SENSE Theatre® training.

Peers Exclusion Criteria:

- Anyone not meeting inclusion criteria.

Primary outcomes:
measure: Change in Incidental Face Memory
timeFrame: Pretest, Posttest (Week 11), Follow-up (Week 21)
measure: Change in Contextual Assessment of Social Skills
timeFrame: Pretest, Posttest (Week 11), Follow-up (Week 21)
measure: Change in Social Responsiveness Scale - Self (SRS)
timeFrame: Pretest, Posttest (Week 11), Follow-up (Week 21)
measure: Change in Social Responsiveness Scale - Other (SRS)
timeFrame: Pretest, Posttest (Week 11), Follow-up (Week 21)
Secondary outcomes:
measure: Cambridge Face Memory Test
timeFrame: Pretest, Week 11, two-month follow-up
measure: Wechsler Memory Scale Face Memory Delay Test
timeFrame: Pretest, Week 11, two-month follow-up
measure: Wechsler Memory Scale Face Memory Test
timeFrame: Pretest, Week 11, two-month follow-up
measure: Adaptive Behavior Assessment System (ABAS) - Self-Report
timeFrame: Pretest, Week 5, Week 11, two-month follow-up
measure: Adaptive Behavior Assessment System (ABAS) - Parent-Report
timeFrame: Pretest, Week 5, Week 11, two-month follow-up
measure: State-Trait Anxiety Inventory (STAI) Scale
timeFrame: Pretest, Week 11, two-month follow-up
measure: The Adult Self Report (ASR)
timeFrame: Pretest, Week 5, Week 11, two-month follow-up
measure: The Adult Behavior Checklist (ABCL)
timeFrame: Pretest, Week 5, Week 11, two-month follow-up
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Blythe A Corbett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: