A Sleep Intervention for Preschoolers in Foster Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBradley Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Nurturing Sleep
BehavioralFirst, 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Nurturing SleepExperimental treatment 1 intervention
Group B: Waitlist controlOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline, and at 2 week and 3 month follow ups2
Child sleep
Participant responses on The Children's Sleep Habits Questionnaire (possible range: 33-99). Higher scores indicate more severe child sleep disturbances.
Time frame
baseline, and at 2 week and 3 month follow ups3
Implementation Outcomes- Acceptability
Participant responses on the Acceptability of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater acceptability.
Time frame
3 month follow up4
Implementation Outcomes- Feasibility
Participant responses on the Feasibility of Intervention Measure. Possible scores range from 5 to 20, with higher scores indicating greater feasibility.
Time frame
3 month follow upSecondary outcomes
1
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.
Time frame
baseline, and at 2 week and 3 month follow ups2
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.
Time frame
baseline, and at 2 week and 3 month follow ups3
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.
Time frame
baseline, and at 2 week and 3 month follow ups4
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.
Time frame
baseline, and at 2 week and 3 month follow upsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bradley Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
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