Sleep deficiency in early childhood, including poorly timed sleep, inadequate sleep duration, and night awakenings, is associated with numerous health concerns such as adiposity, poor emotional regulation, impaired growth, and higher risk of injuries in children aged 0-4 years. Sleep deficiency is more prevalent among children of color and those who are economically marginalized and may contribute to the cycle of disadvantage and higher risk for health disparities by age 4 years compared to higher income and non- Hispanic white children. Behavioral sleep interventions (BSIs) may improve sleep deficiency, but little is known about the feasibility and efficacy of BSIs among racially/ethnically diverse and economically marginalized children. The purpose of this proposed pilot pragmatic cluster randomized trial is to evaluate the feasibility and preliminary efficacy of a BSI, Sleep Well, Bee Well (SWBW) designed for racially/ethnically diverse and economically marginalized toddlers enrolled in federally-funded Early Head Start (EHS) programs. We chose to focus on toddlers aged 1-2.5 years because this is an important developmental stage of rapid cognitive, language, social emotional, and motor development; sleep habits are malleable at this age; and early intervention is key to addressing health disparities. Based on the socioecological model (SEM) of sleep and health, SWBW works at the organizational (EHS teacher-parent), interpersonal (parent-child, EHS teacher- toddler), and individual (toddler) levels. Informed by the constructs of social cognitive theory, SWBW includes interactive multimedia materials and activities to encourage two-way communication between parents and EHS teachers to co-develop tailored sleep health goals towards meeting Bedtime, Environment, and Duration of sleep (B.E.D) recommendations for toddlers. We propose a pragmatic cluster randomized trial to determine the feasibility of SWBW and test the preliminary efficacy of SWBW provided to one EHS center compared to another EHS center with similar enrollment and demographics that will serve as a waitlist control. We will address the following specific aims: (1) Determine the feasibility of SWBW among 44 families of 1-2.5-year-old healthy children and EHS teachers from both childcare centers; (1a) refine and standardize the SWBW intervention materials (videos, handouts, activities); (1b) determine the feasibility (acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing) of the SWBW intervention, study design and recruitment goals; (2) Evaluate the preliminary efficacy of SWBW in 22 intervention and 22 wait-list control parent-child dyads on (2a) toddlers' sleep health (duration, timing, continuity), bedtime routines and parent and EHS teacher sleep knowledge and (2b) toddler's social-emotional health, bedtime routines, parent well-being and parent-teacher engagement. The results from this pilot study will provide support for a future larger scale cluster randomized trial that will be fully powered to test the effects of the SWBW program in multiple EHS programs enrolled in the New England Head Start Association.
Sleep deficiency occurs in more than 25-40% of children by the time they reach preschool (2.5-5 years) and occurs with higher prevalence among children living with socioeconomic adversity. This disparity in sleep health begins as early as 1 year of age and, coupled with the numerous health concerns associated with poor sleep health, may contribute to the cycle of disadvantage. While there is empirical evidence of the effectiveness of behavioral sleep interventions in early childhood, the lack of inclusion of racially/ethnically diverse, economically marginalized children in this research suggests the need for development and testing of behavioral sleep interventions that meet the needs of children most at risk for developing sleep deficiency early in life, as is proposed in this pilot pragmatic cluster randomized trial.
