跳至主要内容
临床试验/NCT04452045
NCT04452045已完成不适用

Feasibility of a Sleep Intervention for Children With Autism Spectrum Disorder Study

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Children's Sleep Habits Questionnaire (CSHQ)

研究概览

简要总结

This proposal will acquire preliminary data on the feasibility and effectiveness of an innovative and scalable strategy for improving access to effective sleep health care for preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop and test an on-line delivery adaptation of the existing behavioral sleep interventions for preschool aged children.

详细描述

Access to effective treatments for sleep disorders is a persistent challenge. This is due to the lack of trained clinicians as well as caregiver resources to seek out and utilize such critical services. The SweetDreams intervention will solve this problem with on-line delivery of educational materials and treatment strategies for an evidence-based intervention. It will be readily available to caregivers at any time and through multiple outlets such a computer, tablet, and telephone, modes of delivery favored by and effective for parents of children in this age group.

This adaptation will address key challenges to sleep health care for children with ASD: (1) Learning differences of children with ASD by incorporating intervention principles from the TEACHH model; (2) Overcome the challenge of treatment access due to the limited number of qualified providers by developing didactic videos for online and mobile device delivery (referred to as SweetDreams); and, (3) Responding to the NIH emphasis on developing "more effective interventions…by targeting interventions to the identified needs of community members," SweetDreams will use a dynamic process involving extensive collaboration with children, parents, developmental pediatricians, and other experts on youth with ASD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • have poor sleep health
  • have a diagnosis of ASD

排除标准

  • any regular sleep medication use (this does not include occasional over the counter sleep aid)
  • known sleep apnea
  • unstable major medical conditions (e.g. severe asthma, diabetes).

结局指标

主要结局

Change in Children's Sleep Habits Questionnaire (CSHQ)

时间窗: baseline to end of treatment (average exposure 1 month)

Validated questionnaire; total score range between 33 and 99, with higher numbers representing more sleep problems

次要结局

  • Change in Pittsburgh Sleep Quality Index (PSQI)(baseline to end of treatment (average exposure 1 month))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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