NCT05130229

Community Partnership for Healthy Sleep: Sleep Well, Bee Well Part 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Using a pragmatic cluster randomized trial, this study aims to examine the feasibility, and acceptability of a 3-week behavioral sleep intervention, Sleep Well, Bee Well (SWBW), and to test the preliminary efficacy of SWBW compared to a wait-list control with children ages 1-2.5 years old at two Early Head Start (EHS) centers on toddler sleep characteristics and parent wellbeing.

Detailed description

The first phase of this study is under another study (please see NCT03045874). For this study (Phase II), a pilot pragmatic cluster randomized trial to test the feasibility and preliminary efficacy of SWBW in improving sleep health in children ages 1-2.5 years attending two Early Head Start (EHS) programs will be studied. A total of 44 families of 1-2.5 year-old healthy children and EHS teachers from both childcare centers will be enrolled. The program teaches early childhood educators about healthy sleep for young children and will train them to be confident facilitators of educational conversations about sleep with parents. The following specific aims will be addressed with this study: (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. Parent questionnaires and sleep characteristics of children (actigraphy and parent report) will be collected at three timepoints- Time 1, 2, and 3. Time 1 is the first Baseline Data Collection for the Waitlist Control Group and Intervention Group, and these data will be collected prior to either group starting the 3-week SWBW intervention. Between Time 1 and Time 2, the Intervention Group will receive the 3-week SWBW intervention at the childcare center. Time 2 data collection for both groups will occur during the week following the completion of the intervention received by the Intervention Group. Time 2 data will serve as post-intervention data for the Intervention Group. Time 2 data will also be compared to the first baseline data collected during Time 1 to account for the Waitlist Control Group's waiting time and be used as secondary baseline pre-intervention data for the Waitlist Control Group. Lastly, Time 3 is the Post-Intervention Data Collection for the Waitlist Control Group and will be examined to assess the sustainability of the intervention in the Intervention Group.

Conditions

• Pediatric Sleep

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Well Bee Well	Sleep program to help toddlers sleep better

Timeline

• Start date: 2022-03-08
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2021-11-23
• Last updated: 2023-12-01

Locations

2 sites across 1 country: United States