A Sleep Intervention for Preschoolers in Foster Care
Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care
2 other identifiers
interventional
72
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
Study Completion
Last participant's last visit for all outcomes
August 31, 2028
August 12, 2024
August 1, 2024
12 months
June 25, 2024
August 7, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Foster parent-child interactions and behaviors around sleep
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.
baseline, and at 2 week and 3 month follow ups
Child sleep
Participant responses on The Children's Sleep Habits Questionnaire (possible range: 33-99). Higher scores indicate more severe child sleep disturbances.
baseline, and at 2 week and 3 month follow ups
Secondary Outcomes (4)
Child health
baseline, and at 2 week and 3 month follow ups
Foster parent sleep
baseline, and at 2 week and 3 month follow ups
Foster parent stress
baseline, and at 2 week and 3 month follow ups
Foster parent health
baseline, and at 2 week and 3 month follow ups
Study Arms (2)
Sleep Wizard
EXPERIMENTALThese participants will be randomized to receive Sleep Wizard.
Waitlist control
OTHERThese 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Darlynn M Rojo-Wissar, PhD, MPH
Bradley Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 25, 2024
First Posted
August 12, 2024
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Not yet decided
- Access Criteria
- Not yet decided
We will adhere to NIH guidelines for the prompt publication of findings, ensure accessibility of publications to the general public, and ensure that scientific findings are shared. Following the conclusion of the study and the release of the primary study results, chances for secondary data analysis will be available and all data gathered in this study will eventually be available for public use.