Child Sleep Clinical Trial
Official title:
Sleep Promotion Intervention for Preschool Children in Bangladesh
Using a pragmatic cluster randomized trial, this study aims to examine the feasibility and acceptability of a 3-week behavioral sleep intervention and to test the preliminary efficacy of the intervention compared to a wait-list control with children ages 2-3 years old at two Early Learning Centers on preschooler's sleep health in Dhaka, Bangladesh.
We will develop a sleep intervention through the adaptation of a sleep promotion program this study (Phase II), a pilot pragmatic cluster randomized trial to test the feasibility and preliminary efficacy of the intervention in improving sleep health in children ages 2-3 years attending two Early Learning Centers programs will be studied. A total of 60 families of 2-3 year-old healthy children and 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 the intervention among 60 families of 2-3-year-old healthy children and teachers from both childcare centers; (1a) refine and standardize the intervention materials (videos, handouts, activities); (1b) determine the feasibility (acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing) of the intervention, study design and recruitment goals; (2) Evaluate the preliminary efficacy of the intervention in 30 intervention and 30 control parent-child dyads on (2a) preschoolers' sleep health (duration, timing, continuity), bedtime routines and parent and teacher sleep knowledge. The results from this pilot study will support a future larger-scale cluster-randomized trial that will be fully powered to test the effects of the intervention in multiple Early Learning Centers in Bangladesh. Parent questionnaires and sleep characteristics of children (actigraphy and parent report) will be collected at three-time points- Time 1, 2, and 3. Time 1 is the first Baseline Data Collection for the Control Group and Intervention Group, and these data will be collected before either group starts the 3-week intervention. Between Time 1 and Time 2, the Intervention Group will receive the 3-week 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. ;