Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Parent Daily Sleep Diaries
研究概览
简要总结
In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child ages 8-17 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
NiteCAPP SINCC
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: NiteCAPP SINCC (Behavioral)
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 parent that measure sleep efficiency, sleep onset latency, and total sleep time. Diaries also measure child behavior.
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
- PROMIS Adult Sleep Disturbance(0 weeks, 6 weeks, 10 weeks)
- Alabama Parenting Questionnaire(0 weeks, 6 weeks, 10 weeks)
- Perceived Stress Scale(0 weeks, 6 weeks, 10 weeks)
- Pediatric Sleep Questionnaire(0 weeks, 6 weeks, 10 weeks)
- Child Disruptive Behavior Disorders Checklist(0 weeks, 6 weeks, 10 weeks)
- Child Actigraphy(24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks)
- Parent Actigraphy(24/7 during the 2 week assessment at 0 weeks, 6 weeks, and 10 weeks)
- Child Heartrate Variability(during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks)
- PROMIS Child Sleep Disturbance(0 weeks, 6 weeks, 10 weeks)
- Beck Depression Inventory-II(0 weeks, 6 weeks, 10 weeks)
- State-Trait Anxiety Inventory(0 weeks, 6 weeks, 10 weeks)
- Epworth Sleepiness Scale(0 weeks, 6 weeks, 10 weeks)
- Parent Heartrate Variability(during a cold-pressor task at 0 weeks, 6 weeks, 10 weeks)
- The Revised Childhood Anxiety and Depression Scale(0 weeks, 6 weeks, 10 weeks)
研究者
Melanie Stearns
Assistant Professor
University of South Florida