Regulating Together: Randomized Controlled Trial Examining Predictors, Facilitators, and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Emotion Dysregulation Inventory- Reactivity
研究概览
简要总结
Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.
详细描述
144 children ages 8-12 years old with autism spectrum disorder will be enrolled in the study and randomized to Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS) groups. Participants will complete assessments at five time points: Screen (T1) Week 0 - where they will complete consent; Baseline (T2); Week 7: Post Active Treatment (includes semi-structured interviews) (T3); Week 16: Post Generalization (T4); Week 29: Final outcome visit (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autism spectrum disorder (ASD)
- •A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test
- •Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R).
- •Caregivers and child are fluent in speaking English
- •Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module
- •Family willing to keep prescribed medication and outside interventions stable
- •willing to participate in twice weekly 90-minute sessions of either Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS).
- •The guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate.
排除标准
- •Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment.
- •any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury
- •Presence of comorbid major neuropsychiatric illness warranting other treatment approaches.
- •Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
研究组 & 干预措施
Regulating Together (RT)
Participants will receive Regulating Together -the emotion dysregulation intervention
干预措施: Regulating Together (RT) (Behavioral)
Achieving Independence and Mastery in School (AIMS)
Participants will receive AIMS, the academic functioning/organizational skill intervention.
干预措施: Achieving Independence and Mastery in School (AIMS) (Behavioral)
结局指标
主要结局
Emotion Dysregulation Inventory- Reactivity
时间窗: Through study completion, about 29 weeks
13-item parent report measure that captures negative emotional responses and Dysphoria characterized by increased negative affect and lack of motivation. Higher scores mean higher emotional reactivity.
次要结局
- Inpatient Hospitalization Rates(during the 6 months prior to enrollment in the study and during the 6 months after completion of the individualized consult)
- Children's Organizational Skills Scale (COSS)(Through study completion, about 29 weeks)
- Daily Phone Diary(Through study completion, about 29 weeks)