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
- 1
- 主要终点
- Child 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
- •Child ages 8-12 with ODD (prior diagnosis) and insomnia
- •Child and parent English proficiency.
- •complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos
- •daytime dysfunction (mood, cognitive, social, academic) due to insomnia
- •baseline diaries and actigraphy indicate >30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights
排除标准
- •Parent unable to provide informed consent or child unable to provide assent
- •Family unwilling to accept random assignment
- •Child/parent participation in another randomized research project
- •Parent unable to complete forms or implement treatment procedures due to cognitive impairment
- •Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation/intent, [frequent] parasomnias)
- •Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and/or melatonin
- •Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial
- •Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)
- •Other conditions adversely affecting trial participation
研究组 & 干预措施
SLEEP: COPE
Content includes both standard CBT-I techniques [sleep hygiene, stimulus control, sleep restriction, cognitive therapy] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age/abilities. Parents will work with children to implement behavioral strategies.
干预措施: SLEEP: COPE (Behavioral)
结局指标
主要结局
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.
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.
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