Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in actigraphic and diary measured sleep quantity and quality measures
研究概览
简要总结
The SHIP study is a randomized controlled trial of an intervention for preschool children with sleep problems, in which we aim to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. In collecting three years of follow-up data, we will be able to determine the impact of the SHIP intervention on childhood sleep problems, obesity, academic achievement, and emotional and behavioral problems, as well as parental stress and daytime tiredness. This study has the dual potential to expand treatment resources for young children with behavioral sleep problems and to increase our scientific understanding of the long-term consequences of early childhood sleep problems.
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
- 30 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-71 months
- •Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night
- •English speaking parent or guardian
排除标准
- •Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5
- •Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids
- •Serious medical conditions likely to affect sleep, including diabetes or cancer
- •Major cognitive or developmental disorder, including autism spectrum disorder
结局指标
主要结局
Change in actigraphic and diary measured sleep quantity and quality measures
时间窗: Baseline, 36-month follow-up
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Change in actigraphic and parent report measures of sleep onset difficulties
时间窗: Baseline, 36-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
次要结局
- Change in child anthropometric measures(Baseline, 36-month follow-up)
- Trajectory in child anthropometric measures(Baseline, 12-month follow-up, 24-month follow-up, 36-month follow-up)
- Change in parent-reported child behavioral and emotional symptoms and executive function(Baseline, 12-month follow-up)
- Change in parent & teacher-reported child behavioral and emotional symptoms and executive function(Baseline, 36-month follow-up)
- Change in parent & teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)(Baseline, 24-month follow-up)
- Change in directly assessed performance on WJIII NU achievement battery and executive function(Baseline, 36-month follow-up)
- Trajectory in actigraphic and diary measured sleep quantity and quality measures(Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up)
- Trajectory in actigraphic and parent report measures of sleep onset difficulties(Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up)
研究者
Michelle Garrison
Research Assistant Professor, University of Washington
Seattle Children's Hospital