Enhancing Social Competence in Adults With Autism Spectrum Disorder: A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in Incidental Face Memory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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))
排除标准
- •Adults with intellectual impairment (WASI; (Wechsler, 2011) score <
- •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.
研究组 & 干预措施
SENSE Theatre
A peer-mediated, theatre-based intervention designed to improve social cognition and behavior.
干预措施: SENSE Theatre (Behavioral)
Waitlist Control Group
This group will not receive the intervention during the testing phase of the intervention but will eventually receive the theatre intervention.
结局指标
主要结局
Change in Incidental Face Memory
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Cambridge Face Memory Test(Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21))
- Wechsler Memory Scale Face Memory Delay Test(Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21))
- Wechsler Memory Scale Face Memory Test(Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21))
- 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))
- 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))
- State-Trait Anxiety Inventory (STAI) Scale(Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21))
- The Adult Self Report (ASR)(Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21))
- The Adult Behavior Checklist (ABCL)(Change from baseline to end of treatment (Week 11) and at Follow-up (Week 21))
研究者
Blythe Corbett
Professor of Psychiatry and Behavioral Sciences
Vanderbilt University Medical Center