Sleep Promotion Intervention in Bangladesh

NCT05763030 | Not Yet Recruiting DMC

• 2 other identifiers: AAAU79431K01TW012425-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep health; Sleep promotion; Child sleep

Outcome Measures

Primary Outcomes (2)

• Intervention feasibility and acceptability

  To determine the feasibility and acceptability of the intervention among families of 2-3 years healthy children and teachers, data will be collected using study-specific Likert-scale surveys. Biweekly site visits and recorded field notes on fidelity will be collected. Together, these field notes will assist in determining the need for intervention refinement and standardization of the intervention manual in preparation for a larger, full-scale future trial. The feasibility goals include \>50% enrollment and \>80% retention rates. Approximate time to complete: 10 minutes. This will be collected at the end of the intervention. The investigators anticipate that the program will be acceptable and feasible to the early learning centers, teachers, and parents.

  21 days

• Change in Parental knowledge and beliefs about children's sleep

  Knowledge, attitudes, self-efficacy, and beliefs about sleep in children (KASB) will be administered. There are seven self-efficacy items. The survey will be collected at Time 1, 2, and 3. The score ranges from 0-76. The investigators anticipate that parental knowledge, attitudes, self-efficacy, and beliefs about their children's sleep will improve upon completion of the intervention.

  21 days

Secondary Outcomes (6)

• Change in Children's bedtime.

  21 days

• Change in Bedtime Variability

  21 days

• Change in Children's sleep duration.

  21 days

• Change in Children's Sleep Duration Variability

  21 days

• Change in Bedtime Routine

  21 days

Study Arms (2)

Intervention

EXPERIMENTAL

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 the intervention 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.

Behavioral: Adapted Sleep Well, Bee Well (SWBW)

Control

NO INTERVENTION

The control arm will not receive the intervention. They will be assessed at time 1 and again at 2, following the completion of intervention in the intervention arm

Interventions

Adapted Sleep Well, Bee Well (SWBW) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 2-3 years
• Attending early learning centers

You may not qualify if:

• Diagnosed with cerebral palsy, severe developmental delay, cardiac disease, or autism
• Known to be born preterm or low birth weight.

Sponsors & Collaborators

• Columbia University: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

International Centre for Diarrhoeal Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Study Officials

• Ayesha Sania, ScD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayesha Sania, ScD

CONTACT

646-774-6242; as4823@cumc.columbia.edu

William P. Fifer, PhD

CONTACT

646-774-6248; wpf1@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)