Early Childhood DevelopmentNCT03753646
Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behavior in Rangpur City Corporation, Bangladesh
A study testing Lactating allowance and psycho social stimulation in people with Early Childhood Development, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Burden: Provision of health care to urban poor population is a great challenge because of supply and demand barriers in the urban health system, which is considered patchy and fragmented. The poor urban people, especially mothers have little access to government health facilities. Read more about this study
- Who is it for?
- Ages 6 to 16 monthsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Development
- What is being tested?
- Lactating allowance and psycho social stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Dec 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 16 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mothers with a child aged 6-16 months
- Not expected to leave the study site for more than 2 months
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Who cannot join
- Legal guardian unwilling or unable to provide written informed consent.
- Known congenital anomaly, developmental disorder or severe developmental delay
- If not possible to test the child due to physical or behavioural problems
- Children of multiple birth e.g. twin, triplets
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
ICDDR,B
Dhaka, 1212
Jena D. Hamadani, Ph. D., 886-052-332 ext. 2353, jena@icddrb.org
About this study
Official title: Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behaviour in Rangpur City Corporation, Bangladesh
Burden:
Provision of health care to urban poor population is a great challenge because of supply and demand barriers in the urban health system, which is considered patchy and fragmented. The poor urban people, especially mothers have little access to government health facilities. The health care platform is not well designed in primary health care delivery for urban health system but presently almost 30 percent people are living in urban area of the country.
Read more
Knowledge gap:
Little is known about what happen if psycho social stimulation is provided using urban lactating allowance program on children's cognition and behavior. There is little information about nature and bottleneck of Early Childhood Development (ECD) activities available in the urban Bangladesh.
Relevance:
This is an opportunity to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program on disadvantaged children's development.
As the urban health system is complex, patchy and fragmented, prior to this intervention An analysis will be done on ECD services and its bottleneck in urban area through Tanahashi framework.
Hypothesis (if any):
Adding psycho social stimulation to urban lactating allowance program will have additional effect on children's cognitive, motor and language development and behavior compared to the comparison group
Secondary Hypothesis:
Additionally the intervention will- improve mothers' quality of life and reduce their depressive symptoms be cost effective,
Objectives:
- To evaluate the effect of integrated urban lactating allowance and psycho social stimulation on children's cognitive, motor and language development and behavior
- To measure nature and bottleneck of ECD services in urban Bangladesh
Secondary objectives:
To measure effect of the programs on:
- mothers' quality of life and mental health (depression symptoms)
- cost effectiveness of the intervention
Methods: A two-arm, Cluster Randomized Controlled Trial: i) Lactating allowance + Psycho social stimulation; (ii) Only lactating allowance
Outcome measures/variables: Children's cognitive, motor and language development measured on Bayley-III, behavior on Wolke's rating scales, Mother's quality of life and depressive symptoms , household food security status, socioeconomic status, quality of home stimulation using family care indicators, Mother's knowledge on child care and development, children's growth measured by length/height, weight and head circumference,mothers' height, weight and mid upper arm circumference, direct and indirect cost of the project.
Read the detailed description
It is estimated that 250 million children do not reach their potential due to poverty, inadequate stimulation and associated risk factors in low and middle income countries.
In Bangladesh more than 50% of children under 5 years are at risk of developmental delay. Urban population is about 28% and it is expected to rise to more than 40% by 2030. In fact, urbanization in Bangladesh is rapidly growing but is not well planned. Poor urban women and children are vulnerable in terms of health and education .
The urban health care facilities are fragmented and patchy and every year rise in population is putting more pressure on health system. Moreover, there is huge economic disparity between rich and poor in the urban areas and poorer people have little access to health care due to both supply and demand barriers. So the situation is rolling more difficult every day.
Ministry of Women and Children Affairs (MOWCA) has taken initiatives to help urban poor mothers through lactating allowance (LA) and limited health education programs. A study conducted in Zimbabwe documented that unconditional cash transfer showed an increase in receiving children's birth certificate and immunization in the age group of 0-4years and school attendance in 6-12 years. Recent systematic review concluded that unconditional cash transfer may not improve health services use in children and adult in low and middle income countries but may have positive impact on food choices and food security. It is expected that this urban lactating allowance will develop economic capacity of people, empower women, improve their quality of life and reduce gender gap.
Very few ECD programs are available for poor urban children especially for the 1st thousand days. The idea is to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program and measuring its effects on disadvantaged children's development.
As the urban health system is complex, patchy and fragmented, prior to this intervention an analysis will be done on ECD services and its bottleneck in the project area through Tanahashi framework. A facility assessment will be done to understand nature of ECD services. A meeting will be conducted with relevant experts to finalize the services delivery mechanism of the intervention.
Research Design and Methods:
This study will follow two sequential stages:
Stage I: Understand nature and analyse bottleneck of ECD services in selected urban areas of Bangladesh through a survey using Tanahasi framework.
Stage II: Document that adding ECD activities to urban lactating allowance program will improve children's cognition, motor, language and behaviour.
Methodology for stage I:
First, an analysis will be done on ECD program in urban area through Tanahashi framework. A documentation will be done on availability, accessibility, utilization and adequate coverage of the ECD activities.
ECD and related services will be analyzed through:
- Household Survey and b) Facility assessment
- Household survey A survey will be conducted with 426 mothers having child less than five years. On an average 22 respondents will be recruited from each cluster. the total clusters will be 20. Sample size was calculated assuming 50% effective coverage, 20% error, 95% confidence interval and 10% refusal rate the total sample size calculated was 426 in an urban setting..
- Facility Assessment Moreover, ECD or relevant services will be collected through visiting service delivery facilities. government and private hospitals, NGOs and schools (kindergarten) will be visited and data will be collected on services available.
At the end of this stage, a stakeholders meeting with relevant experts will be conducted to finalize a service delivery mechanism
Methodology for stage II:
The main aim is to document that adding ECD activities to urban lactating allowance program improves children's cognition, language and motor and behaviour.
Study design:
This is a cluster randomized controlled trial of the effects of adding psycho social stimulation to the existing lactating allowance of the country with 2 arms: i) Psycho social stimulation+ Urban lactating allowance and ii) Only urban lactating allowance.
Selection of the study area:
A municipality will be selected for this study. The Initial plan is to conduct the study in Rangpur City Corporation.
Recruitment:
There will be 20 clusters (10 interventions \& 10 comparisons) and 30 mother child dyads in each cluster. In Rangpure City Corporation there are 33 Wards. A Ward will be considered as a cluster. Cluster will be assigned randomly to intervention or comparisions group. A buffer zone will be made to reduce spill over effect with remaining Wards and or villages.
As the Government is providing urban lactating allowance to 2000 mothers in Rangpur City Corporation, it is expected that there will be approximately at least 50 mother child dyads in each cluster. 30 participants will be selected from the list considering mothers lower age and/or those with single child (if available).
Sample Size:
In total, sample is 600. Previous studies of psycho social stimulation alone achieved an effect size of 0.4 SD on children's development. In this study, lactating allowance (cash) as an intervention that might have also positive effect on the child development. But to be on the safe side, it is assumed that an effect size of 0.35 SD, 80% power, 95% confidence interval, 1.58 cluster design effect and 25% drop-out rate the sample size was calculated to be 300 in each arm with 30 children in each of the 20 clusters.
Data Analysis:
Data will be checked for normality. Appropriate measures will be taken if there are any abnormal distributions. Frequency table and percentage will be used to present nature of ECD services and its bottleneck. Service availability would be presented in a table through facility assessment and the bottlenecks (accessibility, utilization and coverage) will also be presented through interviews with mothers. For intervention trial, differences between groups in background characteristics will be analyzed using t-test for continuous variables and chi-square test for categorical variables.. Effect of the ECD intervention will be measured using intention-to-treat analysis controlling for the clustering effect in multivariate regression analysis. All covariates will be controlled and effect modifier and mulnicolinearity will be checked before regression analysis. Quality of life data will be analysed based on WHO guideline for WHOQoL tools.. Similarly, total score of SRQ will be calculated and then differences between arms will be analysed.
Cost-effectiveness Analysis:
The objective of the study is to estimate the resource use and costs associated with interventions. Direct and indirect cost will be measured for all the groups. Average costs per participants will be calculated by multiplying the cost of resource items by their respective unit costs. Outcomes will be generated from the study after the intervention and the differences will be measured before and after the intervention in two groups. Then the incremental cost-effectiveness ratio (ICER) will be used in cost-effectiveness analysis.
- Conditions
- Early Childhood Development
- Being tested
- Lactating allowance and psycho social stimulation
- Keywords
- Bangladesh, Cognitive development, behavior, quality of life, psycho social stimulation, lactating allowance
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactating allowance and psycho social stimulationOther
Mothers will receive lactating allowance and psycho social stimulation
| Study group | Role | What they receive |
|---|---|---|
| Lactating allowance and psycho social stimulation | Experimental | Mothers will receive lactating allowance and psycho social stimulation Receives: Other: Lactating allowance and psycho social stimulation |
| Only lactating allowance | No intervention | Mothers will receive only lactating allowance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)
Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Measured: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Measured: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Measured: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9
Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Measured: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9
Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Measured: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9
Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a more active status.
Measured: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9
Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Measured: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9
Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Measured: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Secondary outcomes (12)
Children's weight
Children's weight will be measured in Gram
Measured: Change children's weight after one year intervention
Children's height
Children's height will be measured in Gram
Measured: Change children's height after one year intervention
Children's Mid Upper Arm circumference (MUAC)
Children's MUAC will be measured by millimeter
Measured: Change children's MUAC after one year intervention
Mothers' weight
Mothers' weight will be measured in Gram
Measured: Change mother's weight after one year intervention
Mothers' height
Mothers' height will be measured by Centimeter
Measured: Change mother's height after one year intervention
Mothers' Mid Upper Arm circumference (MUAC)
Mothers' Mid Upper Arm circumference (MUAC) will be measured by Centimeter
Measured: Change mother's Mid Upper Arm circumference (MUAC) after one year intervention
Mothers' depressive symptom
Mothers' depressive symptom will be measured by Self-Regulation Questionnaire (SRQ). higher values represent a worse mental status
Measured: Change mother's depression status after one year intervention
Mothers' quality of life status
Mothers' quality of life status will be measured by World Health Organization (WHO) quality of life questionnaire
Measured: Change mother's quality of life status after one year intervention
Family's monthly food security status
Family's monthly food security status will be measured by Household Food Insecurity Access Scale (HFIAS) questionnaire. The status will be measured as per HFIAS analysis guideline developed by the U.S. Agency for International Development (USAID).
Measurement of Food Access:
Indicator Guide
Measured: Change family's food security status after one year intervention
Domestic violence (mothers)
Domestic violence (mothers) monthly status will be measured by questionnaire
Measured: Change family's domestic violence status after one year intervention
Family care indicators (FCI)
Family care indicators (FCI) will be measured by questionnaire. Higher values represent a better environment
Measured: Change of FCI after one year intervention
Mothers' knowledge on parenting
Mothers' knowledge on parenting questionnaire will be used
Measured: Change of mothers' knowledge after one year intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Dec 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Early Childhood DevelopmentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will integrate ECD services to Bangladesh government lactating allowance to measure children's neurocognitive behavior in urban area of Bangladesh.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753646
- Sponsor's protocol ID
- PR-18035
- Status last verified
- Jan 2022
- First submitted
- 19 Nov 2018
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.
PubMed 27717614Hamadani JD, Tofail F, Huda SN, Alam DS, Ridout DA, Attanasio O, Grantham-McGregor SM. Cognitive deficit and poverty in the first 5 years of childhood in Bangladesh. Pediatrics. 2014 Oct;134(4):e1001-8. doi: 10.1542/peds.2014-0694.
PubMed 25266433Afsana K, Wahid SS. Health care for poor people in the urban slums of Bangladesh. Lancet. 2013 Dec 21;382(9910):2049-51. doi: 10.1016/S0140-6736(13)62295-3. Epub 2013 Nov 21. No abstract available.
PubMed 24268606Robertson L, Mushati P, Eaton JW, Dumba L, Mavise G, Makoni J, Schumacher C, Crea T, Monasch R, Sherr L, Garnett GP, Nyamukapa C, Gregson S. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.
PubMed 23453283Pega F, Liu SY, Walter S, Pabayo R, Saith R, Lhachimi SK. Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries. Cochrane Database Syst Rev. 2017 Nov 15;11(11):CD011135. doi: 10.1002/14651858.CD011135.pub2.
PubMed 29139110Ahmed SM, Evans TG, Standing H, Mahmud S. Harnessing pluralism for better health in Bangladesh. Lancet. 2013 Nov 23;382(9906):1746-55. doi: 10.1016/S0140-6736(13)62147-9. Epub 2013 Nov 21.
PubMed 24268003Hossain SJ, Tofail F, Rahman A, Fisher J, Hamadani JD, Rahman SM. Parenting with nutrition education and unconditional cash reduce maternal depressive symptoms and improve quality of life: findings from a cluster randomised controlled trial in urban Bangladesh. Glob Health Action. 2024 Dec 31;17(1):2426784. doi: 10.1080/16549716.2024.2426784. Epub 2024 Nov 19.
PubMed 39560615Hossain SJ, Rahman SM, Fisher J, Rahman A, Tofail F, Hamadani JD. Effect of a parenting and nutrition education programme on development and growth of children using a social safety-net platform in urban Bangladesh: a cluster randomized controlled trial. Lancet Reg Health Southeast Asia. 2024 Mar 19;25:100388. doi: 10.1016/j.lansea.2024.100388. eCollection 2024 Jun.
PubMed 38550293
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behaviour in Rangpur City Corporation, Bangladesh
- ClinicalTrials.gov ID
- NCT03753646
- Acronym / sponsor ID
- PR-18035
- Conditions
- Early Childhood Development
- Keywords
- Bangladesh, Cognitive development, behavior, quality of life, psycho social stimulation, lactating allowance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Nov 2018 (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.
Burden:
Provision of health care to urban poor population is a great challenge because of supply and demand barriers in the urban health system, which is considered patchy and fragmented. The poor urban people, especially mothers have little access to government health facilities. The health care platform is not well designed in primary health care delivery for urban health system but presently almost 30 percent people are living in urban area of the country.
Knowledge gap:
Little is known about what happen if psycho social stimulation is provided using urban lactating allowance program on children's cognition and behavior. There is little information about nature and bottleneck of Early Childhood Development (ECD) activities available in the urban Bangladesh.
Relevance:
This is an opportunity to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program on disadvantaged children's development.
As the urban health system is complex, patchy and fragmented, prior to this intervention An analysis will be done on ECD services and its bottleneck in urban area through Tanahashi framework.
Hypothesis (if any):
Adding psycho social stimulation to urban lactating allowance program will have additional effect on children's cognitive, motor and language development and behavior compared to the comparison group
Secondary Hypothesis:
Additionally the intervention will- improve mothers' quality of life and reduce their depressive symptoms be cost effective,
Objectives:
- To evaluate the effect of integrated urban lactating allowance and psycho social stimulation on children's cognitive, motor and language development and behavior
- To measure nature and bottleneck of ECD services in urban Bangladesh
Secondary objectives:
To measure effect of the programs on:
- mothers' quality of life and mental health (depression symptoms)
- cost effectiveness of the intervention
Methods: A two-arm, Cluster Randomized Controlled Trial: i) Lactating allowance + Psycho social stimulation; (ii) Only lactating allowance
Outcome measures/variables: Children's cognitive, motor and language development measured on Bayley-III, behavior on Wolke's rating scales, Mother's quality of life and depressive symptoms , household food security status, socioeconomic status, quality of home stimulation using family care indicators, Mother's knowledge on child care and development, children's growth measured by length/height, weight and head circumference,mothers' height, weight and mid upper arm circumference, direct and indirect cost of the project.
Detailed description
It is estimated that 250 million children do not reach their potential due to poverty, inadequate stimulation and associated risk factors in low and middle income countries.
In Bangladesh more than 50% of children under 5 years are at risk of developmental delay. Urban population is about 28% and it is expected to rise to more than 40% by 2030. In fact, urbanization in Bangladesh is rapidly growing but is not well planned. Poor urban women and children are vulnerable in terms of health and education .
The urban health care facilities are fragmented and patchy and every year rise in population is putting more pressure on health system. Moreover, there is huge economic disparity between rich and poor in the urban areas and poorer people have little access to health care due to both supply and demand barriers. So the situation is rolling more difficult every day.
Ministry of Women and Children Affairs (MOWCA) has taken initiatives to help urban poor mothers through lactating allowance (LA) and limited health education programs. A study conducted in Zimbabwe documented that unconditional cash transfer showed an increase in receiving children's birth certificate and immunization in the age group of 0-4years and school attendance in 6-12 years. Recent systematic review concluded that unconditional cash transfer may not improve health services use in children and adult in low and middle income countries but may have positive impact on food choices and food security. It is expected that this urban lactating allowance will develop economic capacity of people, empower women, improve their quality of life and reduce gender gap.
Very few ECD programs are available for poor urban children especially for the 1st thousand days. The idea is to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program and measuring its effects on disadvantaged children's development.
As the urban health system is complex, patchy and fragmented, prior to this intervention an analysis will be done on ECD services and its bottleneck in the project area through Tanahashi framework. A facility assessment will be done to understand nature of ECD services. A meeting will be conducted with relevant experts to finalize the services delivery mechanism of the intervention.
Research Design and Methods:
This study will follow two sequential stages:
Stage I: Understand nature and analyse bottleneck of ECD services in selected urban areas of Bangladesh through a survey using Tanahasi framework.
Stage II: Document that adding ECD activities to urban lactating allowance program will improve children's cognition, motor, language and behaviour.
Methodology for stage I:
First, an analysis will be done on ECD program in urban area through Tanahashi framework. A documentation will be done on availability, accessibility, utilization and adequate coverage of the ECD activities.
ECD and related services will be analyzed through:
- Household Survey and b) Facility assessment
- Household survey A survey will be conducted with 426 mothers having child less than five years. On an average 22 respondents will be recruited from each cluster. the total clusters will be 20. Sample size was calculated assuming 50% effective coverage, 20% error, 95% confidence interval and 10% refusal rate the total sample size calculated was 426 in an urban setting..
- Facility Assessment Moreover, ECD or relevant services will be collected through visiting service delivery facilities. government and private hospitals, NGOs and schools (kindergarten) will be visited and data will be collected on services available.
At the end of this stage, a stakeholders meeting with relevant experts will be conducted to finalize a service delivery mechanism
Methodology for stage II:
The main aim is to document that adding ECD activities to urban lactating allowance program improves children's cognition, language and motor and behaviour.
Study design:
This is a cluster randomized controlled trial of the effects of adding psycho social stimulation to the existing lactating allowance of the country with 2 arms: i) Psycho social stimulation+ Urban lactating allowance and ii) Only urban lactating allowance.
Selection of the study area:
A municipality will be selected for this study. The Initial plan is to conduct the study in Rangpur City Corporation.
Recruitment:
There will be 20 clusters (10 interventions \& 10 comparisons) and 30 mother child dyads in each cluster. In Rangpure City Corporation there are 33 Wards. A Ward will be considered as a cluster. Cluster will be assigned randomly to intervention or comparisions group. A buffer zone will be made to reduce spill over effect with remaining Wards and or villages.
As the Government is providing urban lactating allowance to 2000 mothers in Rangpur City Corporation, it is expected that there will be approximately at least 50 mother child dyads in each cluster. 30 participants will be selected from the list considering mothers lower age and/or those with single child (if available).
Sample Size:
In total, sample is 600. Previous studies of psycho social stimulation alone achieved an effect size of 0.4 SD on children's development. In this study, lactating allowance (cash) as an intervention that might have also positive effect on the child development. But to be on the safe side, it is assumed that an effect size of 0.35 SD, 80% power, 95% confidence interval, 1.58 cluster design effect and 25% drop-out rate the sample size was calculated to be 300 in each arm with 30 children in each of the 20 clusters.
Data Analysis:
Data will be checked for normality. Appropriate measures will be taken if there are any abnormal distributions. Frequency table and percentage will be used to present nature of ECD services and its bottleneck. Service availability would be presented in a table through facility assessment and the bottlenecks (accessibility, utilization and coverage) will also be presented through interviews with mothers. For intervention trial, differences between groups in background characteristics will be analyzed using t-test for continuous variables and chi-square test for categorical variables.. Effect of the ECD intervention will be measured using intention-to-treat analysis controlling for the clustering effect in multivariate regression analysis. All covariates will be controlled and effect modifier and mulnicolinearity will be checked before regression analysis. Quality of life data will be analysed based on WHO guideline for WHOQoL tools.. Similarly, total score of SRQ will be calculated and then differences between arms will be analysed.
Cost-effectiveness Analysis:
The objective of the study is to estimate the resource use and costs associated with interventions. Direct and indirect cost will be measured for all the groups. Average costs per participants will be calculated by multiplying the cost of resource items by their respective unit costs. Outcomes will be generated from the study after the intervention and the differences will be measured before and after the intervention in two groups. Then the incremental cost-effectiveness ratio (ICER) will be used in cost-effectiveness analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will integrate ECD services to Bangladesh government lactating allowance to measure children's neurocognitive behavior in urban area of Bangladesh.
| Arm | Type | Receives |
|---|---|---|
| Lactating allowance and psycho social stimulation | Experimental | Other: Lactating allowance and psycho social stimulationMothers will receive lactating allowance and psycho social stimulation |
| Only lactating allowance | No intervention | –Mothers will receive only lactating allowance |
Who may qualify
- Ages
- 6 to 16 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mothers with a child aged 6-16 months
- Not expected to leave the study site for more than 2 months
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Key exclusion criteria (4 listed)
- Legal guardian unwilling or unable to provide written informed consent.
- Known congenital anomaly, developmental disorder or severe developmental delay
- If not possible to test the child due to physical or behavioural problems
- Children of multiple birth e.g. twin, triplets
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 |
|---|---|---|
| Lactating allowance and psycho social stimulationMothers will receive lactating allowance and psycho social stimulation | Other | Lactating allowance and psycho social stimulation |
Primary outcome
Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)
Time frame: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
Time frame: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
Time frame: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status
Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9
Time frame: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9
Time frame: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9
Time frame: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a more active status.
Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9
Time frame: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9
Time frame: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status
12 secondary outcomes
Children's weight
Time frame: Change children's weight after one year intervention
Children's height
Time frame: Change children's height after one year intervention
Children's Mid Upper Arm circumference (MUAC)
Time frame: Change children's MUAC after one year intervention
Mothers' weight
Time frame: Change mother's weight after one year intervention
Mothers' height
Time frame: Change mother's height after one year intervention
Mothers' Mid Upper Arm circumference (MUAC)
Time frame: Change mother's Mid Upper Arm circumference (MUAC) after one year intervention
Mothers' depressive symptom
Time frame: Change mother's depression status after one year intervention
Mothers' quality of life status
Time frame: Change mother's quality of life status after one year intervention
Family's monthly food security status
Time frame: Change family's food security status after one year intervention
Domestic violence (mothers)
Time frame: Change family's domestic violence status after one year intervention
Family care indicators (FCI)
Time frame: Change of FCI after one year intervention
Mothers' knowledge on parenting
Time frame: Change of mothers' knowledge after one year intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 27717614Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.
- Background: PubMed 25266433Hamadani JD, Tofail F, Huda SN, Alam DS, Ridout DA, Attanasio O, Grantham-McGregor SM. Cognitive deficit and poverty in the first 5 years of childhood in Bangladesh. Pediatrics. 2014 Oct;134(4):e1001-8. doi: 10.1542/peds.2014-0694.
- Background: PubMed 24268606Afsana K, Wahid SS. Health care for poor people in the urban slums of Bangladesh. Lancet. 2013 Dec 21;382(9910):2049-51. doi: 10.1016/S0140-6736(13)62295-3. Epub 2013 Nov 21. No abstract available.
- Background: PubMed 23453283Robertson L, Mushati P, Eaton JW, Dumba L, Mavise G, Makoni J, Schumacher C, Crea T, Monasch R, Sherr L, Garnett GP, Nyamukapa C, Gregson S. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.
- Background: PubMed 29139110Pega F, Liu SY, Walter S, Pabayo R, Saith R, Lhachimi SK. Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries. Cochrane Database Syst Rev. 2017 Nov 15;11(11):CD011135. doi: 10.1002/14651858.CD011135.pub2.
- Background: PubMed 24268003Ahmed SM, Evans TG, Standing H, Mahmud S. Harnessing pluralism for better health in Bangladesh. Lancet. 2013 Nov 23;382(9906):1746-55. doi: 10.1016/S0140-6736(13)62147-9. Epub 2013 Nov 21.
- Derived from this study: PubMed 39560615Hossain SJ, Tofail F, Rahman A, Fisher J, Hamadani JD, Rahman SM. Parenting with nutrition education and unconditional cash reduce maternal depressive symptoms and improve quality of life: findings from a cluster randomised controlled trial in urban Bangladesh. Glob Health Action. 2024 Dec 31;17(1):2426784. doi: 10.1080/16549716.2024.2426784. Epub 2024 Nov 19.
- Derived from this study: PubMed 38550293Hossain SJ, Rahman SM, Fisher J, Rahman A, Tofail F, Hamadani JD. Effect of a parenting and nutrition education programme on development and growth of children using a social safety-net platform in urban Bangladesh: a cluster randomized controlled trial. Lancet Reg Health Southeast Asia. 2024 Mar 19;25:100388. doi: 10.1016/j.lansea.2024.100388. eCollection 2024 Jun.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactating allowance and psycho social stimulation in people with Early Childhood Development, run by International Centre for Diarrhoeal Disease Research, Bangladesh 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheikh Jamal Hossain, MPH (02-01712191414, sheikh.jamal@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) (time frame: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753646, which also lists 8 linked publications.
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 11 Feb 2022.