Impact of Bedtime Routines on Sleep and Development in Toddlers
Condition: Sleep; Sleep Disturbance; Child Development
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their
      primary caregivers) at their scheduled 12-month well child care infant visit at Temple
      Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of
      implementation of a bedtime routine program, Connect, Calm, & Comfort: 3 Cs for Bedtime ZZZs,
      to promote better sleep and improve developmental outcomes in toddlers from primarily
      low-income families.
    

Detailed description: 
      A bedtime routine is a key factor in the promotion of not only healthy sleep, but also
      potentially of broad development and wellbeing in early childhood. A bedtime routine, in and
      of itself, embodies the characteristics of nurturing care and early child stimulation
      especially for at-risk children. It is consistent with the Lancet Early Childhood Series
      Steering Committee emphasizing the need for nurturing care, which includes adequate health,
      nutrition, security and safety, responsive caregiving, and early learning opportunities, to
      help young children (ages 0-5 years) reach their full developmental potential, and to build a
      strong foundation for subsequent development, health, and wellbeing. Common, adaptive
      components of a bedtime routine can contribute to an array of positive developmental outcomes
      beyond improved sleep, inclusive of language development, literacy, child emotional and
      behavioral regulation, parent-child attachment, and family functioning, among other outcomes.
      Although studies have been conducted on the relationship between bedtime routines and sleep,
      there have been few studies looking at bedtime routines and other developmental outcomes.
    

Intervention name(s): Bedtime Routine Education
Intervention type(s): Behavioral
Intervention description(s): The intervention aims to promote healthy sleep and improved developmental outcomes in infants. Individualized bedtime routine education, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling will be implemented by research assistants at the 12-month well-child visit. Reinforcement of the bedtime routine education will be implemented at the 15-month visit. Each individualized bedtime routine will incorporate 3-5 steps and a bedtime routine chart depicting those steps will be created and provided to the families. Families will receive materials for their bedtime routines, including a CuddleBright kit, 1-2 additional bedtime books, toothbrush/toothpaste , and the created bedtime chart. On top of that, families will also receive a children's book provided by Reach Out and Read through the study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 100 caregiver-infant dyads (infants ages 12.0 to 14.9 months) will be recruited from Temple Pediatric Care Outpatient Pediatric office with follow-up visits at approximately 15 and 24 months of age.
Masking: None (Open Label)
Primary purpose: Treatment