A Sleep Intervention for Preschoolers in Foster Care

NCT ID: NCT06549491

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-01
• Study Completion Date: 2028-08-31

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep Wizard

These participants will be randomized to receive Sleep Wizard.

Group Type: EXPERIMENTAL

Sleep Wizard

Intervention Type: BEHAVIORAL

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.

Waitlist control

These 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.

Group Type: OTHER

Sleep Wizard

Intervention Type: BEHAVIORAL

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.

Interventions

Sleep Wizard

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Bradley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Darlynn M. Rojo-Wissar, PhD, MPH

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darlynn M Rojo-Wissar, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Bradley Hospital

Central Contacts

Darlynn M Rojo-Wissar, PhD, MPH

Role: CONTACT

darlynn_rojo-wissar@brown.edu

5203903180

Stephanie Parade, PhD

Role: CONTACT

stephanie_parade@brown.edu

401-793-8247

Other Identifiers

K01HL169495

Identifier Type: NIH

Identifier Source: secondary_id

View Link

C148TBZATPA8

Identifier Type: -

Identifier Source: org_study_id