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临床试验/NCT02718196
NCT02718196撤回不适用

Testing and Development of a Sleep Training Mobile Health Application to Address Sleep Problems in the First Two Years of Life

Yale University0 个研究点开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)

研究概览

简要总结

The specific aims of this study are : 1) To pilot test the alpha build prototype of the sleep training smartphone application using a sample of parents looking for sleep training advice online. 1a) To assess the efficacy of the application in helping parents with the sleep training process 1b) To assess the 'workability' of the application 2) Use feedback to guide the next round of development with the goal of building out the applications functionality and increasing usability.

详细描述

Problems with bedtime and night-wakings are common in early childhood. Behavioral interventions to address these sleep problems are commonly referred to as "sleep training" and are effective but difficult for some parents to perform. The investigators have developed a prototype of a novel smartphone application designed to assist parents throughout this process.

The smartphone application first collects basic information from the parents, including: first name of child, number of caregivers participating in bedtime, tolerance of caregivers for crying, and basic information about timing of sleep and wake, as well as information about the usual order of events at bedtime. At each step, a brief (2-3 paragraph) is provided to explain the rationale for the next step, as well as concrete advice on how to succeed. It then walks parents through proven techniques to improve sleep in children in a stepwise fashion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Months 至 24 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •english speaking
  • •parent of child age 6-24 months
  • •target child sleeping in crib in his or her own room (not the same room as the parents or a sibling)
  • •actively looking to sleep train their child
  • •own an iOS or Android smartphone

排除标准

  • •bedsharing/cosleeping with child
  • •target child has a known developmental delay
  • •target child has a significant health issue affecting his/her sleep (failure to thrive, congenital heart disease, etc).

研究组 & 干预措施

Application Users

Experimental

English-speaking parents of children ages 6-24 months who are interested in starting sleep training within the next month.

干预措施: Sleep Training smartphone application (Behavioral)

结局指标

主要结局

Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)

时间窗: 3 months

Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep as a problem?

Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)

时间窗: study entry and 3 months

Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Average number of night wakings per night: ____________

Change in average number of night wakings by Brief Infant Sleep Questionnaire (BISQ)

时间窗: study entry and 1 month

The question is: Average number of night wakings per night: ____________ Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency.

Perception of child's sleep problem- Brief Infant Sleep Questionnaire (BISQ)

时间窗: study entry

Brief Infant Sleep Questionnaire (BISQ)This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep as a problem? □ A very serious problem □ A small problem □ Not a problem at all

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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