Behavioral Sleep Intervention in Urban Primary Care: Aim 3

Study Overview
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Brief Summary
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Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.

Detailed Description
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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 whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude of change in child sleep and behavior from pre-intervention to post-intervention. This is a randomized controlled trial of the Sleep Well! program with pre-intervention, post-intervention, and follow-up 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 behavioral 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 change in child sleep. Tertiary outcomes are the direction and magnitude in change in child behavior. Assessments occur at pre-intervention, post-intervention, and follow-up.

Official Title
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Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 3

Conditions
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Sleep Disturbance, Sleep Deprivation, Sleep

Intervention / Treatment
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* Behavioral: Sleep Well!
* Behavioral: Sleep education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parental/guardian permission (informed consent) Caregiver participant is the parent or legal guardian of the child subject Caregiver/legal guardian is greater than or equal to 18 years of age. Child between the ages of 1 and 5 years. Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire. English-speaking. Exclusion Criteria: Caregiver is not parent or legal guardian of child participant. Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or treatment of the disorder impact sleep. Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites and randomly assigned either to the intervention or to an enhanced usual care condition (sleep education handout).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Well! Intervention<br>Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary. | Behavioral: Sleep Well!<br>* Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally comprised of healthy sleep advice and tested in the context of a sleep health education campaign for impoverished children. Based on preliminary research regarding the need for sleep intervention in primary care, Investigators have expanded the intervention to more comprehensively address 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 who are living in disadvantaged contexts. Intervention components are based on effective pediatric behavioral sleep treatments.<br>|
| Other: Enhanced Usual Care<br>The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance. | Behavioral: Sleep education<br>* Sleep education for caregivers of toddlers and preschoolers is provided via a Parent Family Education handout available to families and clinicians in the CHOP primary care network. The handout contains evidence-based advice about healthy sleep in early childhood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | The study team will track the number of caregiver-child dyad participants who complete all study procedures following enrollment. | 24 months (study duration) | 
| Family Engagement and Adherence | Study interventionists will keep records of family intervention attendance, including the number of sessions that the family attended, rescheduled, and no-showed, and the number of phone calls that families completed. Study interventionists will also keep records of families' usage of intervention strategies, based on feedback from families in-session. | 24 months (study duration) | 
| Treatment Acceptability | Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measures of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention, and the Multicultural Therapy Competency Inventory- Client Version to assess patient's perceptions of the Sleep Well! therapist's cultural sensitivity during discussions about safe sleep. Caregivers will also complete an audio-recorded, open-ended qualitative interview (15-20 minutes) with questions related to aspects of the intervention that were helpful/unhelpful, how the intervention could be improved, and the acceptability of the measurement process. | 3 months (post-intervention) | 
| Assessment Process | The study team will keep records of the number of planned assessments that are completed. | 24 months (study duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Sleep Problems | Caregivers will complete the BCSQ to report on the severity of any caregiver-perceived sleep problems at pre-intervention, post-intervention, and follow-up. | Baseline, post-intervention assessment, and 1 month follow-up | 
| Child Sleep Patterns | Caregivers will complete the BCSQ to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. | Baseline, post-intervention assessment, and 1 month follow-up | 
| Child Sleep Patterns | Caregivers will have their child wear an actigraph to obtain objective estimates of sleep onset, sleep offset, and sleep duration at pre-intervention, post-intervention, and follow-up. | 7 days at baseline, post-intervention assessment, and 1 month follow-up | 
| Child Behavior Problems | Caregivers will complete the Child Behavioral Checklist for ages 1.5-5 years to report on child internalizing and externalizing concerns at pre-intervention, post-intervention, and follow-up. The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior. | Baseline, post-intervention assessment, and 1 month follow-up |