SleepNCT06549491
A Sleep Intervention for Preschoolers in Foster Care
A study testing Nurturing Sleep in people with Sleep and Foster Care, run by Bradley Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Foster Care
- What is being tested?
- Nurturing Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2027to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Implementation of a Digital 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.
Read the 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 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.
- Conditions
- Sleep, Foster Care
- Being tested
- Nurturing Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurturing SleepBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurturing Sleep | Experimental | These participants will be randomized to receive Nurturing Sleep. Receives: Behavioral: Nurturing Sleep |
| Waitlist control | Other | 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. Receives: Behavioral: Nurturing Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, and at 2 week and 3 month follow ups
Implementation Outcomes- Acceptability
Participant responses on the Acceptability of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater acceptability.
Measured: 3 month follow up
Implementation Outcomes- Feasibility
Participant responses on the Feasibility of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater feasibility.
Measured: 3 month follow up
Implementation Outcomes- Appropriateness
Participant responses on the Intervention Appropriateness Measure. Possible scores range from 5 to 20, with higher scores indicating greater appropriateness.
Measured: 3 month follow up
Secondary outcomes (4)
Child health
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.
Measured: baseline, and at 2 week and 3 month follow ups
Foster parent sleep
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.
Measured: baseline, and at 2 week and 3 month follow ups
Foster parent stress
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.
Measured: baseline, and at 2 week and 3 month follow ups
Foster parent health
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.
Measured: baseline, and at 2 week and 3 month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Dec 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Darlynn M. Rojo-Wissar, PhD, MPH, Bradley Hospital
- Investigators
- Darlynn M Rojo-Wissar, PhD, MPH, Principal investigator, Bradley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549491
- Sponsor's protocol ID
- C148TBZATPA8
- Other IDs
- K01HL169495
- Status last verified
- Sep 2025
- First submitted
- 25 Jun 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Digital Sleep Intervention for Preschoolers in Foster Care
- ClinicalTrials.gov ID
- NCT06549491
- Acronym / sponsor ID
- C148TBZATPA8
- Conditions
- Sleep, Foster Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nurturing Sleep | Experimental | Behavioral: Nurturing SleepThese participants will be randomized to receive Nurturing Sleep. |
| Waitlist control | Other | Behavioral: Nurturing SleepThese 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurturing SleepFirst, 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. | Behavioural | Nurturing Sleep, Waitlist control |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Child health
Time frame: baseline, and at 2 week and 3 month follow ups
Foster parent sleep
Time frame: baseline, and at 2 week and 3 month follow ups
Foster parent stress
Time frame: baseline, and at 2 week and 3 month follow ups
Foster parent health
Time frame: baseline, and at 2 week and 3 month follow ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darlynn M Rojo-Wissar, PhD, MPH principal investigator
Bradley Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Nurturing Sleep in people with Sleep and Foster Care, run by Bradley Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darlynn M Rojo-Wissar, PhD, MPH (5203903180, darlynn_rojo-wissar@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foster parent-child interactions and behaviors around sleep (time frame: baseline, and at 2 week and 3 month follow ups). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.