SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Parent Daily Sleep Diaries
研究概览
简要总结
Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Parent Daily Sleep Diaries
时间窗: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Daily diaries filled out by parents that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure parenting techniques.
Child Daily Sleep Diaries
时间窗: Each morning for 14-days at 0 weeks, 6 weeks, and 10 weeks
Daily diaries filled out by children with parent assistance that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.
次要结局
- Child Actigraphy(24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks)
- The Revised Childhood Anxiety and Depression Scale(0 weeks, 6 weeks, 10 weeks)
- PROMIS Child Sleep Disturbance(0 weeks, 6 weeks, 10 weeks)
- Alabama Parenting Questionnaire(0 weeks, 6 weeks, 10 weeks)
- Parent Actigraphy(24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks)
- Child Disruptive Behavior Disorders Checklist(0 weeks, 6 weeks, 10 weeks)
- Epworth Sleepiness Scale(0 weeks, 6 weeks, 10 weeks)
- Child Salivary Cortisol(before and after a cold-pressor task at 0 weeks, 6 weeks, 10 weeks)
- Child Hair Cortisol(0 weeks, 6 weeks, 10 weeks)
- Perceived Stress Scale(0 weeks, 6 weeks, 10 weeks)
- Beck Depression Inventory-II(0 weeks, 6 weeks, 10 weeks)
- PROMIS Adult Sleep Disturbance(0 weeks, 6 weeks, 10 weeks)
- State-Trait Anxiety Inventory(0 weeks, 6 weeks, 10 weeks)
- Pediatric Sleep Questionnaire(0 weeks, 6 weeks, 10 weeks)
研究者
Melanie Stearns
Assistant Professor
University of South Florida