Infant Behavioral Sleep Intervention: Comparative Efficacy
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      While frequent night awakenings in newborns are common and expected, an estimated 20-30% of
      older infants and toddlers have frequent problematic night wakings requiring parental
      intervention throughout the night. Standard infant behavioral sleep intervention approaches,
      which require parental intervention throughout the night, are effective but often difficult
      for families to implement. The aim of this study is to compare the efficacy of two infant
      behavioral sleep interventions with a no treatment condition, on infant sleep and family
      functioning. Healthy infants between the ages of 6 and 18 months with night wakings will be
      randomized into one of three conditions: Entire night intervention, bedtime only
      intervention, or no treatment.
    

Detailed description: 
      Study Design: Randomized controlled trial (RCT). Approximately thirty participants will be
      randomized to a control condition or one of two intervention conditions.

      Participants: Participants are healthy infants between the ages of 6 and 18 months who wake
      during the night, and their parents. Parents must be willing to engage in infant behavioral
      sleep intervention.

      Study Procedure: Participant recruitment strategies include direct referrals from community
      primary care providers (PCP)s, signs posted in medical offices, and social media posts.
      Participants will be screened and consented via phone. Team members will conduct three home
      visits with participating families to install videorecording device and actigraphy and take a
      sleep history (Visit 1); teach families the intervention (Visit 2); and remove monitoring
      equipment and offer intervention to families in the control condition (Visit 3). Parents will
      be asked to complete daily sleep logs and three sets of surveys using REDCap.

      Intervention: The intervention consists of an infant behavioral sleep protocol. For both
      intervention conditions an interventionist will collaborate with the family to design a
      tailored sleep schedule and bedtime routine. The interventionist will then teach the family a
      behavioral approach, which involves placing the infant in his/her crib awake, and leaving the
      room. The behavioral approach will be individually tailored for each family (e.g., periodic
      checks). The two intervention conditions differ in regards to the timing of the intervention.
      In the all night condition, which represents a standard intervention approach, parents are
      asked to implement the behavioral protocol at bedtime and at subsequent night wakings. In the
      bedtime only condition, parents are asked to implement the behavioral protocol at bedtime
      only, and to soothe their infant back to sleep following night wakings.

      Measures: Infant sleep will be assessed via parent-report (sleep diary and validated
      measure); actigraphy; and videosomnography. Parent sleep, parent mood, and infant mood will
      be assessed via validated parental-report survey measures.

      Collaborators on this study include: AJ Schwichtenberg, Purdue University; Jodi Mindell,
      Saint Joseph University.
    

Intervention name(s): Bedtime routine; Sleep schedule; Intervention (bedtime); Intervention (after night wakings)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Tailored bedtime routine; Tailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime.; Parents implement behavioral sleep intervention at bedtime.; Parents implement behavioral sleep intervention following each night waking.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Families are randomly assigned to one of three groups: control, bedtime only (intervention), or all night (intervention).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infant behavioral sleep intervention; Infant sleep; Pediatric insomnia; Infant night wakings