Status:
NOT_YET_RECRUITING
A Sleep Intervention for Preschoolers in Foster Care
Lead Sponsor:
Bradley Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep
Eligibility:
All Genders
21+ years
Phase:
NA
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 digi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06549491
Start Date
September 1 2026
End Date
August 31 2028
Last Update
August 12 2024
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