A Sleep Intervention for Preschoolers in Foster Care

Официальное название

Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Nurturing Sleep
  First, foster parents will fill out the child sleep questionnaire, which will screen for behavioral and medical sleep issues. Foster parents will then complete introductory modules focused on general sleep hygiene and education. Next, they will access tailored sleep strategy modules determined by an automated algorithm based on sleep challenges identified in the sleep screening. Participants will be notified to alert the child's pediatrician if the screening indicates the presence of a medical s

Первичные конечные точки

• Foster parent-child interactions and behaviors around sleep [Срок оценки: baseline, and at 2 week and 3 month follow ups]
• Child sleep [Срок оценки: baseline, and at 2 week and 3 month follow ups]
• Implementation Outcomes- Acceptability [Срок оценки: 3 month follow up]
• Implementation Outcomes- Feasibility [Срок оценки: 3 month follow up]
• Implementation Outcomes- Appropriateness [Срок оценки: 3 month follow up]

Вторичные конечные точки (4)

• Child health [Срок оценки: baseline, and at 2 week and 3 month follow ups]
• Foster parent sleep [Срок оценки: baseline, and at 2 week and 3 month follow ups]
• Foster parent stress [Срок оценки: baseline, and at 2 week and 3 month follow ups]
• Foster parent health [Срок оценки: baseline, and at 2 week and 3 month follow ups]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06549491 · C148TBZATPA8 · K01HL169495

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗