Behavioral Sleep Intervention in Urban Primary Care: Aim 3
Condition: Sleep Disturbance; Sleep Deprivation; Sleep
MeSH terms: Dyssomnias; Parasomnias; Sleep Deprivation
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Sleep Well!; Sleep education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary purpose: Treatment