Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Child Sleep Quality
研究概览
简要总结
Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior 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
- None
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child between 5-9 years of age
- •child have been diagnosed with type 1 diabetes for at least 12 months
- •caregiver lives with child
- •caregiver can read/speak English
排除标准
- •child has other major health problems or sleep disorders other than insufficient sleep or insomnia
- •participating in other intervention studies
研究组 & 干预措施
Usual Care
Usual Care
Sleep Coach Jr.
Parents randomized to the intervention condition will receive a binder with the treatment manual, and the intervention will be administered in person (first session) and via telephone (second session) on an individual basis. The first session will focus on parent education and developing a positive bedtime routines, and the second session will be used to address barriers specific to the individual child.
干预措施: Sleep Coach Jr. (Behavioral)
结局指标
主要结局
Child Sleep Quality
时间窗: 3 months
Child sleep quality (measured with Child Sleep Habits Questionnaire)
Child Sleep Duration
时间窗: 3 months
Child sleep duration (measured with actigraphy)
次要结局
- Parent Sleep Quality(3 months)
- Child Behavior Problems(3 months)
- Parental Fear of Hypoglycemia(3 months)
- Glycemic Control(3 months)
- Parent Sleep Duration(3 months)
- Parental Diabetes Distress(3 months)
- Parental Well-being(3 months)
研究者
Sarah Jaser
Associate Professor of Pediatrics
Vanderbilt University Medical Center