Prevention Strategies to Enhance Young Children's Sleep Development - Part 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Trial-related feasibility - recruitment capability
研究概览
简要总结
The goal of this pilot randomized controlled trial is to test the feasibility, acceptability, and preliminary signal of effect of a combined school- and home-based sleep promotion program for young children prior to the kindergarten transition.
详细描述
This pilot randomized controlled study will test a combined school- and home-based sleep promotion intervention designed to improve young children's sleep and classroom behavior. Classrooms will be randomized to either the intervention or waitlist control group. Intervention content will be delivered via text message to parents' phones and in the classroom. The primary aim of this study is to assess the feasibility and acceptability of the intervention. The secondary aim is to assess the preliminary signal of effect on children's sleep and classroom behavior. Findings from this study will inform any necessary intervention modifications prior to a fully powered randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child between the ages of 4-6 years
- •Currently enrolled in a participating school's 4-year-old kindergarten (4K) classroom
- •Parent/guardian willing to complete questionnaires in English
- •Parent/guardian must have access to a mobile phone with texting capability
排除标准
- •Parent or child has a medical condition that impairs their ability to participate
结局指标
主要结局
Trial-related feasibility - recruitment capability
时间窗: Through recruitment period, up to 6 weeks
Recruitment capability will be measured by the proportion of eligible children who enroll at baseline
Intervention-related feasibility - rate of attendance
时间窗: Weekly through study completion (weeks 1-4)
Children's attendance at school during intervention sessions will be provided by class records.
Intervention-related feasibility - participant adherence to intervention (home)
时间窗: Weekly through study completion (weeks 1-4)
Adherence to the home-based component will rely on link usage data to assess parent engagement with the online materials. Investigators will extract information related to the number of parents who click links from weekly material and number of parents who do not open links.
Intervention-related feasibility - participant adherence to intervention (school)
时间窗: Weekly through study completion (weeks 1-4)
School-based adherence will be assessed by a teacher-completed survey which will indicate whether or not they implemented the intervention each week
Intervention-related feasibility - data collection completion rates
时间窗: Weekly through study completion (weeks 1-4)
Data collection completion rates will be calculated to understand the feasibility of data collection protocols
Intervention-related feasibility - data collection feasibility
时间窗: Post-intervention (week 5-9)
Feasibility of data collection procedures will be assessed with qualitative feedback from parents during semi-structured interviews following the study.
Acceptability
时间窗: Weekly through study completion (weeks 1-4), post-intervention (week 5-9)
Acceptability of the intervention conditions is defined as participants' perception that the intervention is satisfactory and will be assessed with short weekly questionnaires for parents and teachers. Overall acceptability will be assessed with an exit-survey consisting of Likert-scale items and open-ended responses to understand likes/dislikes, content, logistics, and feedback for future iterations. Likert-style questions will have response options ranging from 1-5 with greater scores representing higher acceptability.
Trial-related feasibility - retention
时间窗: Weekly through study completion (weeks 1-5)
Retention will be measured by the proportion of enrolled children who remain in the study through the length of the intervention. Reasons for dropout will also be assessed
Intervention-related feasibility - intervention fidelity
时间窗: Weekly through study completion (weeks 1-4)
Intervention fidelity, the delivery of the intervention as originally planned, will be assessed via teacher report. Intervention fidelity will be assessed with a study-specific questionnaire to assess if all classroom components were delivered as planned.
次要结局
- Child sleep - device-based duration(Baseline (week 0), post-intervention (week 5), follow up (week 17))
- Child sleep - device-based timing(Baseline (week 0), post-intervention (week 5), follow up (week 17))
- Child sleep - Bedtime Routines Questionnaire(Baseline (week 0), post-intervention (week 5), follow up (week 17))
- Child behavior(Baseline (week 0), post-intervention (week 5), follow up (week 17))
- Child inhibition(Baseline (week 0) and post-intervention (week 5))
- Child working memory(Baseline (week 0) and post-intervention (week 5))
- Child cognitive flexibility(Baseline (week 0) and post-intervention (week 5))
研究者
Sarah Burkart
Assistant Professor
University of South Carolina