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临床试验/NCT04539990
NCT04539990Unknown不适用

A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

Soroka University Medical Center0 个研究点目标入组 100 人开始时间: 2020年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Child Sleep Habits Questionnaire

研究概览

简要总结

The present study will test the effectiveness of a behavioral intervention program that targets sleep problems in 1.5-5-year-old children with ASD. Sleep patterns will be measured using questionnaires and sleep diaries that will be completed by the parents as well as by Fitbit sensors that will be placed on the child's wrist or back of the arm. The study will also explore whether specific child (e.g., severity of cognitive abilities) or parent characteristics (e.g., parent stress levels) impact the effectiveness of the intervention. In addition, we will examine whether changes in sleep disturbances are associated with changes in the family's quality of life.

研究设计

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

入排标准

年龄范围
18 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parents of 1.5-5-year-old children with autism will be asked to fill the Child Sleep Habits Questionnaire (CSHQ). Those who report high scores on the following 3 CSHQ subscales will be invited to participate: bedtime resistance, sleep onset delay, and night-wakings.

排除标准

  • 未提供

研究组 & 干预措施

Behavioral Sleep Treatment

Experimental

Parents of children with autism will come to two group meetings (up to 5 families in each group) where they will be receive information regarding sleep hygiene and behavioral techniques for reducing sleep onset delays and night awakenings. The program will last 8 weeks. Meetings will be held on week 1 and week 3. In addition parents will receive a weekly phone call where they will be asked about their ability to implement the behavioral techniques.

Sleep of the children will be measured using questionnaires, sleep diaries and with a Fitbit sensor before and after the program.

干预措施: Behavioral treatment for sleep difficulties (Behavioral)

结局指标

主要结局

Child Sleep Habits Questionnaire

时间窗: 8 weeks after program begins

Parent questionnaire regarding sleep habits of their child

Night time sleep as measured by Fitbit sensor

时间窗: 8 weeks after program begins

Sensor is placed on the arm of the child for 5 days and measures sleep

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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