A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Sleep Duration
研究概览
简要总结
The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health.
The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants?
Participants randomized to the SIESTA intervention will:
- Attend 4 remotely administered group sleep hygiene education sessions
- Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
- Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
- Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
Participants randomized to the Child Health Control condition will:
- Attend 4 remotely administered group sessions covering general health topics
- Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator
- Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.
- Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.
详细描述
Sleep is essential for optimal health and development. Poor sleep is associated with impaired functioning and academic performance, and worse health outcomes in children. Latino children are disproportionately present in urban settings, and due to their exposure to higher levels of urban and cultural stressors, are at greater risk for poor sleep hygiene and quality.
SIESTA (School Intervention to Enhance Latino Students' Time Asleep) is a novel sleep hygiene intervention for improving sleep hygiene and sleep duration in urban Latino middle schoolers in two geographic areas with a high proportion of urban Latino children at increased risk for poor sleep health: Providence, Rhode Island, and San Juan, Puerto Rico.
SIESTA involves 4 group sessions administered in school to Latino middle schoolers (6th-8th grade) and two child-caregiver sessions administered remotely by a bilingual (English/Spanish) trained facilitator from the community.
The goal of this project is to administer a two-site hybrid type 1 effectiveness-implementation design to evaluate SIESTA's effects on a larger-scale- for addressing Latino middle schooler's sleep health, while also assessing implementation determinants.
The first aim of the study is to evaluate SIESTA through a large-scale RCT with urban middle school students in Providence, RI and San Juan, Puerto Rico. The researchers will enroll 150 Latino children per site (N=300), and randomly assign them either to the SIESTA intervention, or to the Sleep Education plus Child Health attention-control condition (9 groups of each of the two conditions, per site; 8-9 students per group). Treatment effects on primary sleep outcomes will be evaluated, including sleep duration, efficiency and sleep onset latency. Secondary sleep outcomes will include sleep hygiene behaviors, the sleep environment, and sleep-related disturbances and impairment. Assessments will occur prior to, immediately following, and at 4, 8, and 12 months after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The research assistants collecting outcomes data post-intervention will be blinded to group assignment.
入排标准
- 年龄范围
- 11 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children must be middle schoolers between 11-13 years old, live and go to school in one of the targeted school districts and sleep no more than 9 hours on an average night
排除标准
- •Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and/or are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.
研究组 & 干预措施
SIESTA
The SIESTA Intervention includes 4, 60-minute group remote sessions by a trained facilitator, and 2, 90-minute family sessions in their home 1 week after group Sessions 1 and 4. SIESTA incorporates key sleep hygiene principles and strategies critical to optimal sleep health in middle schoolers and tailored to urban Latino children's cultural background and urban setting. Areas of focus include the importance of adequate sleep duration, principles and strategies to enhance sleep hygiene, and characteristics of healthy sleep environments, and were developed with targeted goals. After intervention group Session 1, daily sleep questions about the child participant are completed, including key sleep parameters (bedtime, rise time, night awakenings) and sleep hygiene behaviors (daytime naps, electronics, caffeine use) via Qualtrics. Responses are summarized and presented pictorially in caregiver-child sessions to facilitate developing sleep goals for the youth and assess their progress.
干预措施: SIESTA (Behavioral)
Sleep Education plus Child Health attention control
A facilitator from the community will deliver this attention control condition, which consists of the same number of sessions as SIESTA but will focus only on basic sleep hygiene education plus general child health topics (e.g., nutrition, physical activity, safety). It is expected that this will exert limited treatment effects on sleep hygiene, because it does not 1) involve effective behavioral approaches for this age group, or 2) include content tailored for urban Latinos.
干预措施: Sleep education and health education control (Behavioral)
结局指标
主要结局
Sleep Duration
时间窗: Sleep duration will be assessed for 1-2 weeks at baseline, immediately after the intervention ("end of treatment") and at follow ups at 4, 8, and 12 months post intervention/control.
Sleep Duration through actigraphy will be calculated through Time in Bed (TIB) scores. A daily diary will document sleep events (e.g., bedtime) to score actigraphic data . Children will wear the actigraph Motion Logger device for 1-2 weeks at each time point. Data will be compared to data in a family-report daily diary using standard procedures.
Sleep Efficiency/Quality
时间窗: Sleep efficiency will be assessed for 1-2 weeks at baseline, end of treatment and at each 4, 8, and 12 months post intervention/control.
Sleep efficiency will be estimated via actigraphy and will be calculated through % epochs of sleep between sleep start and sleep end.
次要结局
- Sleep Disturbance and Sleep-related Impairment(Sleep Disturbance and Sleep-related Impairment measures will be collected on each child at each of the of the 5 research assessment time points: enrollment/baseline, immediately after the intervention, and at the 4, 8 and 12 month follow up visits.)