Sleep Promotion Intervention in Bangladesh

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sleep Promotion Intervention for Preschool Children in Bangladesh

Conditions
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Child Sleep

Intervention / Treatment
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* Behavioral: Adapted Sleep Well, Bee Well


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy children aged 2-3 years attending early learning centers Exclusion Criteria: Children will not be included if they have a diagnosis of cerebral palsy, severe developmental delay, cardiac disease, or autism and are known to be born preterm or low birthweight.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Children's bedtime. | The bedtime sleep characteristics will be measured with the Respironics Actiwatch AW2, an accelerometer placed on child's wrist. Reliability for actigraphy in preschool children ranges from .67-.85 when measuring sleep duration. The children will wear the water resistant Actiwatch 2 for seven 24-hour periods at Time 1, 2, and 3. The investigators hypothesize that the intervention will improve children' objectively measured bedtime (goal: bedtime before 9:00PM or at least 45 minutes earlier from baseline). Actigraphs are manually reviewed with sleep diaries for confirmation and scoring of variables is done in Actiware software then processed in R and submitted to statistician for calculation. | 21 days | 
| Change in Bedtime Variability | Night-to-night variability of bedtime will be calculated using a series of successive differences created by calculating the differences among adjacent observations within the same subject from the Actiwatch 2 data at Time 1, 2, and 3. The mean squared successive differences can be used to compute the MSSD that is considered to be an index of variability/instability. The investigators hypothesize that the intervention will improve children' objectively measured bedtime variability. Actigraphs are manually reviewed with sleep diaries for confirmation and scoring of variables is done in Actiware software then processed in R and submitted to statistician for calculation. | 21 days | 
| Change in Children's sleep duration. | The sleep characteristic of sleep duration will be measured with the Respironics Actiwatch AW2, an accelerometer placed on the ankle of the children. Reliability for actigraphy in children ranges from .67-.85 when measuring sleep duration. The child will wear the water resistant Actiwatch 2 for seven 24-hour periods at Time 1, 2, and 3. The investigators hypothesize that child's sleep duration will increase by 45 minutes after receiving the intervention. Actigraphs are manually reviewed with sleep diaries for confirmation and scoring of variables is done in Actiware software then processed in R and submitted to statistician for calculation. | 21 days | 
| Change in Children's Sleep Duration Variability | Night-to-night variability of sleep duration will be calculated using a series of successive differences created by calculating the differences among adjacent observations within the same subject from the Actiwatch 2 data at Time 1, 2, and 3. The mean squared successive differences can be used to compute the MSSD that is considered to be an index of variability/instability. The investigators hypothesize that the intervention will improve children's objectively measured sleep duration variability. Actigraphs are manually reviewed with sleep diaries for confirmation and scoring of variables is done in Actiware software then processed in R and submitted to statistician for calculation. | 21 days | 
| Change in Bedtime Routine | Parent reported sleep characteristics will be measured with the Brief Infant Sleep Questionnaire-Revised (BISQ-R) at Time 1, 2, and 3. Each BISQ-R subscale and total score are scaled from 0 to 100. The BISQ-R has been validated against sleep diaries and actigraphy to elicit parent reports of children's sleep patterns (daytime and nocturnal sleep duration, frequency of awakening, sleep latency), sleep habits [sleeping arrangements, parent-child interactions about sleep (e.g., bedtime behaviors, behaviors related to nocturnal awakenings)], sleep difficulty (i.e., bedtime resistance, nocturnal awakenings, and snoring, a risk factor for sleep apnea]. Questions include information about bedtime routine activities and consistency. Approximate time to complete: 10 minutes. The investigators anticipate an improvement in the three subscales and total score of the parent-reported sleep characteristics after receiving the intervention. | 21 days | 
| Change in Parent reported sleep characteristics | Parent reported sleep characteristics will be measured with the Brief Infant Sleep Questionnaire-Revised (BISQ-R) at Time 1, 2, and 3. Each BISQ-R subscale and total score are scaled from 0 to 100. The BISQ-R has been validated against sleep diaries and actigraphy to elicit parent reports of children's sleep patterns (daytime and nocturnal sleep duration, frequency of awakening, sleep latency), sleep habits [sleeping arrangements, parent-child interactions about sleep (e.g., bedtime behaviors, behaviors related to nocturnal awakenings)], sleep difficulty (i.e., bedtime resistance, nocturnal awakenings, and snoring, a risk factor for sleep apnea]. Approximate time to complete: 10 minutes. The investigators anticipate an improvement in the total score of the parent-reported sleep characteristics after receiving the intervention. | 21 days |