跳至主要内容
临床试验/NCT06618040
NCT06618040招募中不适用

Bedtime Stories: Tailored Sleep Health Messaging for Caregivers

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年4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
招募中
入组人数
75
试验地点
1
主要终点
Knowledge, Perceptions, and Practices

研究概览

简要总结

To date, there are very few established sleep health education models targeting caregivers of school-aged children from historically marginalized and/or low income communities. To address this significant gap, this project seeks to examine the feasibility, acceptability, and usability of the Bedtime Stories Sleep Health Education Program to improve sleep behavior. Bedtime Stories is a multi-stakeholder (health care providers, school-aged children, and caregivers of school-aged children) and a multi-component program. The caregiver component of the program utilizes mobile health technology with targeted and tailored sleep health messaging for caregivers of school-aged children. Addressing these aims will help to mitigate gaps in the delivery of health care services to caregivers and families in low income and historically marginalized communities, where services and interventions are scant.

详细描述

Healthy sleep practices are a fundamental component of sleep education interventions designed to prevent sleep problems from developing (Masten et al., 2006) and aide in managing existing sleep disorders such as insomnia in children (Moore et al., 2007). Although poor sleep is linked to a host of negative outcomes, sleep health may also be viewed in a positive light, i.e., "sleep wellness" that places the emphasis on the benefits of good sleep and its importance to overall health maintenance and improvement. Indeed, both the positive and negative aspects of sleep are highly relevant with regards to developing sleep health educational programs, while providing concrete targets for health promotion, wellness and prevention. Fostering healthy sleep habits in children and adolescents builds the foundation for healthy sleep habits in adulthood (Galland et al., 2010). A major challenge to identifying sleep concerns in children is that identification often relies on parent reported concerns, professional clinical judgment, and the presence of symptomatology that changes with age. The early diagnosis of sleep concerns is a key factor to enable access to interventions that improve sleep health. To address this critical gap requires targeted interventions tailored to healthcare providers, particularly those serving communities and populations most in need.

Interventions for caregivers focused on sleep health, including sleep health practice, building and supporting routines, and consistent sleep schedules are integral features to sleep. Settings to promote healthy sleep practices including well-child visits. The well-child visit is an opportunity to educate parents about normal sleep in children and provide strategies to prevent sleep problems from either developing, or if problems already exist from becoming chronic. Community health centers which serve both children and adults, afford unique opportunities to incorporate screening and the prevention of sleep disorders; and deliver coordinated health messages to parents and children in order to effect positive behavioral change within the entire family.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old or over
  • Caregivers of school-aged children (5-11 years of age) that receive care at participating community healthcare centers in the Boston area
  • English fluency

排除标准

  • Planning on moving within the next 3 months
  • Does not live in the home with the child

研究组 & 干预措施

Sleep Health Education Program for Caregivers

Experimental

The BTS-C is an online sleep health education program that is located on a mobile application. The BTS-C utilizes asynchronous avatar-based interactive learning and educational content and videos that are tailored to the caregivers' goals and expectations, paired with targeting messages for change surrounding principles of sleep health practices. The modules will be completed over the course of 6 weeks.

干预措施: Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C) (Behavioral)

结局指标

主要结局

Knowledge, Perceptions, and Practices

时间窗: Follow Up, after 8 weeks

Using the parent Knowledge, Attitudes, Self-Efficacy, and Beliefs scale (adapted questionnaire), 19-item questionnaire; minimum score is 19 and maximum score is 95. A higher score means better sleep habits.

Feasibility, acceptability, and usability

时间窗: Follow Up, after 8 weeks

Using the Brief Feedback questionnaire (BFQ), 15-item questionnaire; total score

Assessment of Child Sleep

时间窗: 1 week baseline, 1 week follow up, entire study

Using a sleep diary (1-week; sleep duration, total sleep time) and the Fitbit Inspire 3 (sleep duration, sleep efficiency, regulatory of sleep time)

Child Sleep Health

时间窗: Baseline (at week 0), Follow Up (after 8 weeks)

Using the Child Sleep Habits Questionnaire: 22-item parent report; Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, daytime sleepiness; total score

次要结局

  • Child Sleep Environment(Baseline (at week 0))
  • Child Sleep Disturbance Impairments(Baseline (at week 0), Follow Up (after 8 weeks))
  • Assessment of parent/caregiver sleep(Baseline (at week 0), Follow Up (after 8 weeks), Entire Study (8 weeks))
  • Caregiver Stress(Baseline (at week 0), Follow Up (after 8 weeks))

研究者

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

Judith Owens

Professor of Neurology

Boston Children's Hospital

研究点 (1)

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