Telephone Care Management to Address Sleep Problems in Young Children With Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Children's Sleep Habits Questionnaire
研究概览
简要总结
The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).
详细描述
Please see brief summary.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism Spectrum Disorder
- •Regular telephone service for caregiver
- •Stable dose of medication
排除标准
- •Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring)
- •Receptive language skills under 18 months
结局指标
主要结局
Children's Sleep Habits Questionnaire
时间窗: 2 month follow-up
次要结局
- Actigraphy (Activity Monitoring)(2 month follow up)
研究者
Jack Stevens
Principal Investigator
Nationwide Children's Hospital