SleepNCT05763030
Sleep Promotion Intervention in Bangladesh
A study testing Adapted Sleep Well, Bee Well (SWBW) in people with Sleep, run by Columbia University at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Adapted Sleep Well, Bee Well (SWBW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- Apr 2027to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 2-3 years
- Attending early learning centers
Who cannot join
- Diagnosed with cerebral palsy, severe developmental delay, cardiac disease, or autism
- Known to be born preterm or low birth weight.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
International Centre for Diarrhoeal Research, Bangladesh
Dhaka, 1212
Ayesha Sania, Sc.D., 646-774-6242, as4823@cumc.columbia.edu
Shams El Arifeen, PhD
About this study
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.
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.
Read the detailed description
Poor sleep in children is a growing public health concern worldwide. Sleep health is a multidimensional construct (sleep-related behaviors, satisfaction, alertness, timing, efficiency, and duration) influenced by a complex interplay of social-ecological factors. Sleep impacts a range of physical health and neurodevelopmental outcomes including children's executive function (EF), growth, and obesity risk, which are public health priorities in low-and-middle-income countries (LMICs). Early EFs are predictive of social competence and academic performance and economic achievement in later life. Childhood obesity is a rapidly growing health issue in LMICs and a leading risk factor of diabetes. Interventions targeting modifiable sleep behavior have the potential to improve long-term physical and neurodevelopmental outcomes for millions of children in LMICs. Most data on children's sleep health are from high-income settings, and the recommendations based on these studies are not directly relevant to LMICs. Emerging evidence shows multiple cross-cultural differences in sleep dimensions in early childhood. Children in Asian countries have a significantly later bedtime and shorter sleep duration compared to children in Western countries. Recent research and our preliminary data suggest that 40% of preschool children in urban Bangladesh sleep less than the recommended duration (10-13 hours) by the World Health Organization (WHO). Evidence from high-income settings links individual (e.g., age, screen time, physical activity), interpersonal (e.g., maternal mood, parenting stress, mother-child interaction), and social (e.g., social socioeconomic condition, household crowding) factors to childhood sleep. We aim to study the determinants of sleep health using a socioecological framework, and the role of sleep health on growth and neurodevelopmental outcomes among 300 preschool children in Bangladesh, a lower-middle-income country in South Asia.
- Conditions
- Sleep
- Being tested
- Adapted Sleep Well, Bee Well (SWBW)
- Keywords
- Sleep health, Sleep promotion, Child sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Sleep Well, Bee Well (SWBW)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 21 days
Secondary outcomes (6)
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.
Measured: 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 (MSSD) 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study startApr 2027 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Ayesha Sania, Columbia University
- Investigators
- Ayesha Sania, ScD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763030
- Sponsor's protocol ID
- AAAU7943
- Other IDs
- 1K01TW012425-01
- Status last verified
- Jul 2024
- First submitted
- 28 Feb 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Promotion Intervention for Preschool Children in Bangladesh
- ClinicalTrials.gov ID
- NCT05763030
- Acronym / sponsor ID
- AAAU7943
- Conditions
- Sleep
- Keywords
- Sleep health, Sleep promotion, Child sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Fogarty International Center of the National Institute of Health
- Study start
- Apr 2027 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Poor sleep in children is a growing public health concern worldwide. Sleep health is a multidimensional construct (sleep-related behaviors, satisfaction, alertness, timing, efficiency, and duration) influenced by a complex interplay of social-ecological factors. Sleep impacts a range of physical health and neurodevelopmental outcomes including children's executive function (EF), growth, and obesity risk, which are public health priorities in low-and-middle-income countries (LMICs). Early EFs are predictive of social competence and academic performance and economic achievement in later life. Childhood obesity is a rapidly growing health issue in LMICs and a leading risk factor of diabetes. Interventions targeting modifiable sleep behavior have the potential to improve long-term physical and neurodevelopmental outcomes for millions of children in LMICs. Most data on children's sleep health are from high-income settings, and the recommendations based on these studies are not directly relevant to LMICs. Emerging evidence shows multiple cross-cultural differences in sleep dimensions in early childhood. Children in Asian countries have a significantly later bedtime and shorter sleep duration compared to children in Western countries. Recent research and our preliminary data suggest that 40% of preschool children in urban Bangladesh sleep less than the recommended duration (10-13 hours) by the World Health Organization (WHO). Evidence from high-income settings links individual (e.g., age, screen time, physical activity), interpersonal (e.g., maternal mood, parenting stress, mother-child interaction), and social (e.g., social socioeconomic condition, household crowding) factors to childhood sleep. We aim to study the determinants of sleep health using a socioecological framework, and the role of sleep health on growth and neurodevelopmental outcomes among 300 preschool children in Bangladesh, a lower-middle-income country in South Asia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Adapted Sleep Well, Bee Well (SWBW)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. |
| 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 |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children aged 2-3 years
- Attending early learning centers
Key exclusion criteria (2 listed)
- Diagnosed with cerebral palsy, severe developmental delay, cardiac disease, or autism
- Known to be born preterm or low birth weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Intervention feasibility and acceptability
Time frame: 21 days
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.
Change in Parental knowledge and beliefs about children's sleep
Time frame: 21 days
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.
6 secondary outcomes
Change in Children's bedtime.
Time frame: 21 days
Change in Bedtime Variability
Time frame: 21 days
Change in Children's sleep duration.
Time frame: 21 days
Change in Children's Sleep Duration Variability
Time frame: 21 days
Change in Bedtime Routine
Time frame: 21 days
Change in Parent reported sleep characteristics
Time frame: 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayesha Sania, ScD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Sleep Well, Bee Well (SWBW) in people with Sleep, run by Columbia University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Sania, ScD (646-774-6242, as4823@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility and acceptability (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.