An interventional study of Sleep Well! in Sleep Disturbance, Sleep Deprivation and Sleep, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 12 Months to 5 Years. Per ClinicalTrials.gov, last updated 2021-10-08.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
Investigators will enroll up to 20 participants from 3 Children's Hospital of Philadelphia (CHOP) primary care locations. The primary objective is to determine the whether the Sleep Well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. The direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES children or in primary care, an accessible service delivery setting. The primary objective of this study is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. We will also examine the direction and magnitude of change in child sleep from pre-intervention to post-intervention. This is a preliminary open trial of the Sleep Well! program with pre-intervention and post-intervention assessments.Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.
Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported sleep problem or who are not getting enough sleep. The intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. The primary outcomes for this open trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. Secondary outcomes are the direction and magnitude in any pre- to post-intervention change in child sleep.
300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.
This study's enrollment of 15 is below the median of 45 across 248 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime.
Behavioral: Sleep Well!
The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate)
The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment.
Time frame: Approximately 9 months
Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility)
The study team will track the number of proportion of participants who complete all assessments (pre-intervention and post-intervention) that were planned.
Time frame: Approximately 9 months
Treatment Acceptability (Strategies)
Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. Ratings are shown for proportion of caregivers agreeing or strongly agreeing with the statement that the strategies are acceptable.
Time frame: 3 months
Cultural Humility
Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version (MTCI-CV), adapted to assess perceptions of the Sleep Well! therapist's/program's cultural humility (e.g. "When we discussed my child's sleep, the Sleep Well! therapist seemed to have some understanding about my/my family's culture and background" and "When we discussed my child's sleep, the Sleep Well! therapist appreciated my expertise on my own life.") Average proportion of caregivers agreeing/strongly agreeing with statements on measure is reported.
Time frame: 3 months
Sleep Patterns and Problems: Sleep Problem
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child sleep.
Time frame: Baseline (pre-intervention) and 3 months (post-intervention).
Sleep Patterns and Problems: Sleep Onset Latency
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. When completing the BCSQ, caregivers are prompted to think about their child's sleep on a "typical night" over the past week (7 nights). Sleep onset latency is assessed by asking caregivers to report in minutes how long it typically takes their child to fall asleep.
Time frame: 3 months
Sleep Patterns and Problems: Night Awakening Duration
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
Time frame: 3 months
Sleep Patterns and Problems: Nighttime Sleep Duration
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
Time frame: 3 months
Sleep Patterns and Problems: 24-hour Sleep Duration
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
Time frame: 3 months
| Milestone | Behavioral Sleep Intervention |
|---|---|
| Started | 15 |
| Completed | 12 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 1 |
The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment.
| Participants | Behavioral Sleep Intervention |
|---|---|
| Retained in intervention | 13 |
| Attrition from intervention | 2 |
The study team will track the number of proportion of participants who complete all assessments (pre-intervention and post-intervention) that were planned.
| Participants | Behavioral Sleep Intervention |
|---|---|
| All assessments completed | 12 |
| Post-intervention assessment not completed | 3 |
Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. Ratings are shown for proportion of caregivers agreeing or strongly agreeing with the statement that the strategies are acceptable.
| Caregivers | Behavioral Sleep Intervention |
|---|---|
| Treatment Acceptability (Strategies) | 12 |
Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version (MTCI-CV), adapted to assess perceptions of the Sleep Well! therapist's/program's cultural humility (e.g. "When we discussed my child's sleep, the Sleep Well! therapist seemed to have some understanding about my/my family's culture and background" and "When we discussed my child's sleep, the Sleep Well! therapist appreciated my expertise on my own life.") Average proportion of caregivers agreeing/strongly agreeing with statements on measure is reported.
| Participants | Behavioral Sleep Intervention |
|---|---|
| Agree/strongly agree | 9 |
| Neutral | 1 |
| Disagree/strongly disagree | 0 |
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child sleep.
| Participants | Behavioral Sleep Intervention |
|---|---|
| Reduction from sleep problem at pre to no sleep problem at post | 8 |
| Sleep problem at both pre and post | 4 |
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. When completing the BCSQ, caregivers are prompted to think about their child's sleep on a "typical night" over the past week (7 nights). Sleep onset latency is assessed by asking caregivers to report in minutes how long it typically takes their child to fall asleep.
| minutes | Behavioral Sleep Intervention |
|---|---|
| Pre-intervention | 69.00 ± 50.41 |
| Post-intervention | 25.83 ± 10.62 |
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
| minutes | Behavioral Sleep Intervention |
|---|---|
| Pre-intervention | 131.25 ± 121.55 |
| Post-intervention | 27.50 ± 58.56 |
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
| hours | Behavioral Sleep Intervention |
|---|---|
| Pre-intervention | 6.63 ± 1.99 |
| Post-intervention | 9.21 ± 1.21 |
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
| hours | Behavioral Sleep Intervention |
|---|---|
| Pre-intervention | 8.71 ± 3.28 |
| Post-intervention | 9.98 ± 1.03 |
Collected over Through study completion; approximately 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Sleep Intervention | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
At baseline, we collected data from 15 caregiver-child dyads that initiated the intervention. Three families were lost to follow-up so post-intervention data were collected from 12 caregiver-child dyads.
| Age, Categorical(Participants) | Behavioral Sleep Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | Behavioral Sleep Intervention |
|---|---|
| Mean | 3.00 ± 1.36 |
| Sex: Female, Male(Participants) | Behavioral Sleep Intervention |
|---|---|
| Female | 11 |
| Male | 4 |
| Sex: Female, Male(Participants) | Behavioral Sleep Intervention |
|---|---|
| Female | 15 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Behavioral Sleep Intervention |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Behavioral Sleep Intervention |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Behavioral Sleep Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 13 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Behavioral Sleep Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 12 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
2 further baseline measures are reported on the registry.
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Plan to share: No
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Children's Hospital of Philadelphia