Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K01HL169495 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurturing Sleep | Experimental | These participants will be randomized to receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, and at 2 week and 3 month follow ups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Darlynn M Rojo-Wissar, PhD, MPH | Contact | 5203903180 | darlynn_rojo-wissar@brown.edu | |
| Stephanie Parade, PhD | Contact | 401-793-8247 | stephanie_parade@brown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Darlynn M Rojo-Wissar, PhD, MPH | Bradley Hospital | Principal Investigator |
Not provided
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.
Not provided
Not yet decided
Not yet decided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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. | baseline, and at 2 week and 3 month follow ups |