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临床试验/NCT01729715
NCT01729715已完成不适用

Helping Young Children Sleep

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Brief infant sleep questionnaire

研究概览

简要总结

The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.

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
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 6-36 months
  • difficulties falling asleep or staying asleep
  • DVD and internet access

排除标准

  • Under 14 pounds
  • Requires nighttime feeding or parental intervention for health reasons
  • Chronic medical or psychological conditions such as asthma or autism
  • Parents prefer co-sleeping

研究组 & 干预措施

Internet

Experimental

Internet site that offers parents tips on promoting sleep in infants and toddlers

干预措施: Internet (Behavioral)

DVD

Experimental

DVD that offers parents tips on promoting sleep in infants and toddlers

干预措施: DVD (Behavioral)

No treatment

No Intervention

结局指标

主要结局

Brief infant sleep questionnaire

时间窗: 3 weeks

infant sleep patterns and sleep problems

次要结局

  • Profile of mood states(1 week)
  • Pittsburgh sleep quality index(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Splaingard

Prof. and Dir. of pediatric sleep medicine

Nationwide Children's Hospital

研究点 (2)

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