Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549491
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
A Sleep Intervention for Preschoolers in Foster Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens sleep
For Sleep Wizard pretesting N10 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 N72 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
For Sleep Wizard pretesting N10 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 N72 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None