PROJECT SUMMARY
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.