Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intervention feasibility: recruitment screening eligibility
研究概览
简要总结
In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.
详细描述
This pilot study tested a parenting intervention to improve young children's sleep in families with low income using a randomized controlled trial (RCT) design. Parents were randomized to the intervention or wait-list control group. Intervention content was delivered in virtual sessions with a parent and interventionist. The primary aim was to examine intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal of preliminary efficacy on intervention changes in child sleep patterns to inform a future large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as indicators for potential spillover effects on these domains.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents or primary caregivers 18 years of age or older
- •Have a child 2-4 years of age
- •Child's 24-hour sleep duration does not meet established recommendations based on child age
- •English speaking
- •Annual household income <= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC)
- •Computer or phone access for video calls
排除标准
- •Parent or child has a medical condition that impairs their ability to participate
- •Child has a clinical sleep disorder
- •Child takes medication that significantly impacts their sleep
结局指标
主要结局
Intervention feasibility: recruitment screening eligibility
时间窗: Through study completion, an average of 2 years
Percent of children screened who were eligible
Intervention feasibility: recruitment screening enrollment
时间窗: Through study completion, an average of 2 years
Percent of eligible children who were enrolled
Intervention feasibility: recruitment duration
时间窗: Through study completion, an average of 2 years
Duration to reach the target sample
Intervention feasibility: Enrollment yield for each recruitment strategy
时间窗: Through study completion, an average of 2 years
Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies.
Intervention feasibility: retention attendance
时间窗: Through study completion, an average of 2 years
Percent attendance at assessment visits
Intervention feasibility: retention percentage
时间窗: Through study completion, an average of 2 years
Percent of sample retained at post-intervention
Intervention feasibility: retention dropout
时间窗: Through study completion, an average of 2 years
Percent of sample that drops out or is lost to follow-up
Intervention feasibility: retention dropout reasons
时间窗: Through study completion, an average of 2 years
Reasons for dropping out of the study
Intervention acceptability
时间窗: Through study completion, an average of 2 years
Acceptability will be assessed in an exit survey with Likert scale items and open-ended questions about intervention likes/dislikes and suggestions for future changes. Likert scale values range 1-5. Higher numbers indicate better outcomes (e.g., more positive acceptability)
次要结局
- Child sleep: night sleep duration(Baseline (0 weeks) and post-intervention (6 weeks))
- Child sleep: daytime sleep duration(Baseline (0 weeks) and post-intervention (6 weeks))
- Process measures: Intervention attendance(Through study completion, an average of 2 years)
- Process measures: Content fidelity(Through study completion, an average of 2 years)
- Process measure: Implementation(Through study completion, an average of 2 years)
- Child sleep: 24-hour sleep duration(Baseline (0 weeks) and post-intervention (6 weeks))
- Child sleep: sleep quality(Baseline (0 weeks) and post-intervention (6 weeks))
- Child sleep: sleep timing(Baseline (0 weeks) and post-intervention (6 weeks))
研究者
Elizabeth Adams
Assistant Professor
University of South Carolina