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NCT Number: NCT06549491

A Sleep Intervention for Preschoolers in Foster Care

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.

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Key information

Conditions

Sleep Foster Care

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 Nurturing Sleep, which will be designed to support foster parents around preschool aged foster children's sleep.

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

For the Nurturing Sleep RCT (N=72) participants will be randomized to receive Nurturing Sleep, 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 Nurturing Sleep 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 Nurturing Sleep intervention content. Participants in both groups will complete follow-up assessments at 2-weeks and 3-months following the initial baseline assessment. At the 3-month assessment, participants in the Nurturing Sleep condition will also provide quantitative data on implementation outcomes, including acceptability, feasibility, and appropriateness. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Nurturing Sleep

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 Nurturing Sleep 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 outcomes

  1. Foster parent-child interactions and behaviors around sleep

    Time frame: baseline, and at 2 week and 3 month follow ups

    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.

  2. Child sleep

    Time frame: baseline, and at 2 week and 3 month follow ups

    Participant responses on The Children's Sleep Habits Questionnaire (possible range: 33-99). Higher scores indicate more severe child sleep disturbances.

  3. Implementation Outcomes- Acceptability

    Time frame: 3 month follow up

    Participant responses on the Acceptability of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater acceptability.

  4. Implementation Outcomes- Feasibility

    Time frame: 3 month follow up

    Participant responses on the Feasibility of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater feasibility.

  5. Implementation Outcomes- Appropriateness

    Time frame: 3 month follow up

    Participant responses on the Intervention Appropriateness Measure. Possible scores range from 5 to 20, with higher scores indicating greater appropriateness.

Secondary outcomes

  1. Child health

    Time frame: baseline, and at 2 week and 3 month follow ups

    Participant responses on The Child Behavior Checklist. Scores are percentile based, with higher scores indicating more severe total problems (e.g., internalizing and externalizing symptoms). Scores in the 95th percentile and below are in the normal range, scores in the 96th to 97th percentile are borderline, and scores in the 98th percentile and above are in the clinical range.

  2. Foster parent sleep

    Time frame: baseline, and at 2 week and 3 month follow ups

    Participant responses on the Pittsburgh Sleep Quality Index (PSQI). The possible range for the Global PSQI score is 0-21, with higher scores indicating worse sleep quality.

  3. Foster parent stress

    Time frame: baseline, and at 2 week and 3 month follow ups

    Participant responses on The Parenting Stress Index-4-Short Form. This 36 item measure yields a total stress score with a possible raw score range of 0-180, with higher scores indicating higher levels of stress in the parental role.

  4. Foster parent health

    Time frame: baseline, and at 2 week and 3 month follow ups

    Participant responses on The Patient-Reported Outcomes Measurement Information System (PROMIS)-General Health 1.2. This is a 10-item measure of global health status. Scores are computed to derive a global physical health (4 items) and mental health (4 items) subscale. Possible scores on each subscale range from 4-20, with higher scores indicating better health/functioning. Two additional items assess general health and social role satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Darlynn M Rojo-Wissar, PhD, MPH

CONTACT

[email protected]

5203903180

Stephanie Parade, PhD

CONTACT

[email protected]

401-793-8247

Sponsors and collaborators

Lead sponsor

Bradley Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care

Important dates

Study start
2027
Primary completion
2029
Study completion
2030
First posted
Aug 12, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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