Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Foster parent-child interactions and behaviors around sleep
研究概览
简要总结
Healthy sleep is critical for optimal health and development, but there are no public health interventions to support sleep for children in foster care. This proposal will develop and implement a digital public-health-level intervention to support foster caregivers in promoting healthy sleep in the young children in their care. The digital intervention approach has the potential to maximize scalability and reach to support foster children and their caregivers on a national level.
详细描述
Participants who meet inclusion criteria via phone screen will be scheduled for a virtual HIPAA compliant Zoom enrollment visit where informed consent will be obtained using the REDCap online platform. This study focuses on evaluation of the behavioral sleep intervention Nurturing Sleep, which will be designed to support foster parents around preschool aged foster children's sleep.
For Nurturing Sleep pretesting (N=10), participants will participate in an hour-long virtual study visit where they will access the Nurturing Sleep mobile website. After accessing intervention content, they will provide qualitative data on implementation outcomes, including acceptability, feasibility, and appropriateness.
For the Nurturing Sleep RCT (N=72) participants will be randomized to receive Nurturing Sleep, or to the waitlist control condition using the randomization module in REDCap. They will then complete baseline measures of demographic characteristics, their behaviors and interactions with their foster child related to sleep, perceptions of foster child sleep and health, and their own sleep and health. All questionnaires will be completed in REDCap, with the exception of the baseline questionnaire on child sleep which will be completed in the Nurturing Sleep mobile website for those in the intervention group. Assistance will be available to support participants and ensure completion of measures in real time. The enrollment visit is expected to take 1 hour to complete. Participants in the intervention group will then access the Nurturing Sleep intervention content. Participants in both groups will complete follow-up assessments at 2-weeks and 3-months following the initial baseline assessment. At the 3-month assessment, participants in the Nurturing Sleep condition will also provide quantitative data on implementation outcomes, including acceptability, feasibility, and appropriateness. Follow-up visits will occur over Zoom and will take an average of 30-minutes during which participants will repeat baseline questionnaires via REDCap. At the end of the 3-month follow-up visit, participants in the control group will be offered 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
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are only recruited for Aims 2 (Nurturing Sleep pretest) and 3 (RCT of Nurturing Sleep) of the study and must be a US foster parent of a preschool aged child (36 to 71 months) and have a smartphone. Foster parents will be adults 21 years of age or older, per federal requirements for foster parent licensing.
排除标准
- •Participants will be excluded from the study if they are not English or Spanish speaking, or if the child they are to report on has a serious medical condition or developmental disability that the sleep intervention would not be appropriate for because their medical condition requires more specialized strategies (e.g., cerebral palsy, seizures, autism spectrum disorders). If there is more than one preschool aged child under the foster parent's care, they will implement the intervention and answer study questionnaires based on the child for whom they are most concerned about their sleep.
研究组 & 干预措施
Waitlist control
These participants will be part of the waitlist control condition At the end of the 3-month follow-up visit, participants in the control group will be offered the intervention.
干预措施: Nurturing Sleep (Behavioral)
Nurturing Sleep
These participants will be randomized to receive Nurturing Sleep.
干预措施: Nurturing Sleep (Behavioral)
结局指标
主要结局
Foster parent-child interactions and behaviors around sleep
时间窗: baseline, and at 2 week and 3 month follow ups
Participant responses on The Parent-Child Sleep Interactions Scale (possible range: 0-48). Higher scores indicate a higher frequency of parent-child interactions and behaviors that have been shown to be associated with poorer child sleep.
Child sleep
时间窗: baseline, and at 2 week and 3 month follow ups
Participant responses on The Children's Sleep Habits Questionnaire (possible range: 33-99). Higher scores indicate more severe child sleep disturbances.
Implementation Outcomes- Acceptability
时间窗: 3 month follow up
Participant responses on the Acceptability of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater acceptability.
Implementation Outcomes- Feasibility
时间窗: 3 month follow up
Participant responses on the Feasibility of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater feasibility.
Implementation Outcomes- Appropriateness
时间窗: 3 month follow up
Participant responses on the Intervention Appropriateness Measure. Possible scores range from 5 to 20, with higher scores indicating greater appropriateness.
次要结局
- Foster parent sleep(baseline, and at 2 week and 3 month follow ups)
- Child health(baseline, and at 2 week and 3 month follow ups)
- Foster parent health(baseline, and at 2 week and 3 month follow ups)
- Foster parent stress(baseline, and at 2 week and 3 month follow ups)
研究者
Darlynn M. Rojo-Wissar, PhD, MPH
Assistant Professor
Bradley Hospital