Clinical trial NCT06549491: A Sleep Intervention for Preschoolers in Foster Care
Official title: Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-12
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 sleep disorder, such as sleep disordered breathing. Participants will be asked to follow recommended sleep strategies for 2 weeks, and complete short morning daily diaries on the child?s sleep from the night prior within the Sleep Wizard platform. To reinforce intervention content and enhance adherence and integrity, participants will receive appropriately timed tailored text message reminders of strategies they should be utilizing.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 Sleep Wizard, which will be designed to support foster parents around preschool aged foster children's sleep.

For Sleep Wizard pretesting (N=10), participants will participate in an hour-long virtual study visit where they will access the Sleep Wizard mobile website. After accessing intervention content, they will provide quantitative and qualitative data on implementation outcomes, including acceptability, feasibility, and appropriateness.

For the Sleep Wizard RCT (N=72) participants will be randomized to receive Sleep Wizard, 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 Sleep Wizard 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 Sleep Wizard intervention content. Participants in both groups will complete follow-up assessments at 2-weeks and 3-months following the initial baseline assessment. 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.

Eligibility criteria: Inclusion Criteria:

* Participants are only recruited for Aims 2 (Sleep Wizard pretest) and 3 (RCT of Sleep Wizard) 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Foster parent-child interactions and behaviors around sleep
timeFrame: baseline, and at 2 week and 3 month follow ups
measure: Child sleep
timeFrame: baseline, and at 2 week and 3 month follow ups
Secondary outcomes:
measure: Child health
timeFrame: baseline, and at 2 week and 3 month follow ups
measure: Foster parent sleep
timeFrame: baseline, and at 2 week and 3 month follow ups
measure: Foster parent stress
timeFrame: baseline, and at 2 week and 3 month follow ups
measure: Foster parent health
timeFrame: baseline, and at 2 week and 3 month follow ups
Other outcomes:
Locations:
Study officials:
affiliation: Bradley Hospital
name: Darlynn M Rojo-Wissar, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: