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.
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 and follow-up. 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 pilot 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
103
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.
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.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Retention Rate (Intervention Feasibility)
The study team will track the number of caregiver-child dyad participants assigned to the Sleep Well! condition who complete the intervention as a measure of retention, or intervention feasibility. The retention rate reported is for those who completed all sessions and phone calls for the Sleep Well! intervention.
Time frame: Study duration (up to 24 weeks)
Family Engagement (Sessions)
For families randomized to the intervention condition, study interventionists will rate family engagement during telehealth sessions using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across sessions 1, 2, and 3.
Time frame: Study duration (up to 24 weeks)
Family Engagement (Telephone Calls)
For families randomized to the intervention condition, study interventionists will rate family engagement during telephone calls using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across all completed telephone calls.
Time frame: Study duration (up to 24 weeks)
Treatment Acceptability
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. For this reported outcome, caregivers responded to the statement "I found these strategies to be an acceptable way of dealing with my child's sleep" on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree," with higher scores reflecting stronger acceptability.
Time frame: Time 2 (an average of 9 weeks post-baseline)
Treatment Acceptability: Cultural Humility
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Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version, adapted for the current study, to assess participants' perceptions of the Sleep Well! therapist's cultural humility during the intervention. Caregivers in the intervention condition responded to the statement "When we discussed my child's sleep, my Sleep Well! therapist was accepting of my family's values and beliefs," on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree." Higher ratings indicate greater perceived cultural humility.
Time frame: Time 2 (an average of 9 weeks post-baseline)
Assessment Process (Study Feasibility)
The study team will keep records of the number of planned assessments that are completed (i.e., the entire assessment was completed) as a measure of study feasibility.
Time frame: Study duration (up to 24 weeks)
Severity of Child Sleep Problems
Caregivers will complete a Brief Child Sleep Questionnaire item to report on the severity of any caregiver-perceived sleep problems at pre-intervention, post-intervention, and follow-up. Caregivers reported on the severity of child sleep problems on a 5-point Likert scale; responses were then dichotomized as in prior research such that 0= no to very small sleep problem and 1= small, moderate, or serious sleep problem. Higher scores indicate worse sleep problems.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Problems: Bedtime Difficulties
Caregivers will complete a Brief Child Sleep Questionnaire item to report on the severity of child bedtime difficulties at pre-intervention, post-intervention, and follow-up. Caregivers reported on the severity of bedtime difficulties on a 5-point Likert scale; responses were then dichotomized as in prior research such that 0= easy to somewhat easy bedtime and 1= somewhat difficult, difficult, or very difficult at bedtime. Higher scores indicate greater bedtime difficulties.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Sleep Onset Latency
Caregivers will complete the Brief Child Sleep Questionnaire (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. Caregivers responded to a BCSQ question regarding the time the child took to fall asleep in minutes after lights out. Higher values indicate a longer period of time to fall asleep in minutes.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Number of Wakings Per Night
Caregivers will complete the Brief Child Sleep Questionnaire (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. Caregivers responded to a BCSQ question regarding the number of times their child woke during the night. Higher values indicate more frequent wakings per night.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Duration of Wakings Per Night
Caregivers will complete the Brief Child Sleep Questionnaire (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. Caregivers responded to a BCSQ question regarding the total time in minutes their child was awake during the night. Higher values indicate longer night wakings in minutes.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Nighttime Sleep Duration
Caregivers will complete the Brief Child Sleep Questionnaire (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. Caregivers responded to a BCSQ question regarding the total time their child slept overnight in hours. Higher values indicate longer nighttime sleep duration in hours.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Total 24-hour Sleep Duration
Caregivers will complete the Brief Child Sleep Questionnaire (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. Caregivers responded to a BCSQ question regarding the total time their child slept overnight, and a BCSQ question regarding the total time their child slept during the day for naps. Responses to these two items were summed to estimate total (24-hour) sleep duration in hours. Higher values indicate longer total sleep duration in hours.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration
Caregivers will have their child wear an actigraph to obtain estimates of sleep onset, sleep offset, and sleep duration at pre-intervention, post-intervention, and follow-up. Nighttime sleep duration in minutes is obtained from scoring sleep onset and sleep offset in combination with caregiver-reported nightly sleep diaries of bed and wake times. Nighttime sleep duration is expressed as the average sleep duration in hours across the 7 nights of actigraphy at each timepoint. Higher values indicate longer average nighttime sleep duration.
Time frame: 7 days at Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Behavior Problems: Externalizing Problems
Caregivers will complete the Child Behavioral Checklist (CBCL) for ages 1.5-5 years to report on child internalizing and externalizing concerns at Baseline, Time 2 (post-intervention), and Time 3 (follow-up). The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior. The Externalizing T-score is generated from caregiver-rated raw items that are summed and converted to T-scores based on CBCL normative data. Higher T-scores indicate greater externalizing problems. 50 indicates the population mean with a standard deviation of 10. A T-score of 65-69.9 indicates elevated concerns and a T-score of 70 and above indicates clinically significant concerns.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Behavior Problems: Internalizing Problems
Caregivers will complete the Child Behavioral Checklist (CBCL) for ages 1.5-5 years to report on child internalizing and externalizing concerns at Baseline, Time 2 (post-intervention), and Time 3 (follow-up). The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior. The Internalizing T-score is generated from caregiver-rated raw items that are summed and converted to T-scores based on CBCL normative data. Higher T-scores indicate greater internalizing problems. 50 indicates the population mean with a standard deviation of 10. A T-score of 65-69.9 indicates elevated concerns and a T-score of 70 and above indicates clinically significant concerns.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)