Sleep Promotion Intervention in Bangladesh

NCT05763030 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-12

No results posted yet for this study

Summary

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.

The investigators will use novel, inexpensive wearable technology to measure sleep health of children at ages 2, 3, and 4 years in a total of 60 families of 2-3 year-old healthy children and teachers from both childcare centers. 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.

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.

Conditions

  • Sleep

Interventions

BEHAVIORAL

Adapted Sleep Well, Bee Well (SWBW)

The SWBW is a 3-week multilevel behavioral sleep intervention that targets organizational (daycare worker-parent), interpersonal (parent-child, daycare worker-child), and individual (child) levels. It provides parent education supporting parent-child interaction at bedtime, helps to adopt a bedtime routine and early bedtime (Table 4). At the beginning of the 3-week intervention period, the parent and teacher co-develop tailored sleep health goals towards meeting the Bedtime, Environment, and Duration (BED) recommendations139-141 for the child. Parents receive an inexpensive bedtime kit, a storybook, and an informational brochure. The parent and child select four activities from the kit to perform at bedtime every night. The brochure has a section for the parents to write sleep goals. During the intervention, daycare teachers provide daily feedback support to parents at pick-up or drop-off. The program has a manualized structured curriculum suitable for use by paraprofessionals.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER
  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • Columbia University

    lead OTHER

Principal Investigators

  • Ayesha Sania, ScD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-04-30
Primary Completion
2028-04-30
Completion
2028-06-30

Countries

  • Bangladesh

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05763030 on ClinicalTrials.gov