Clinical trial NCT03753646: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Childhood Development
Keywords: Bangladesh
Cognitive development
behavior
quality of life
psycho social stimulation
lactating allowance
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will integrate ECD services to Bangladesh government lactating allowance to measure children's neurocognitive behavior in urban area of Bangladesh.
Primary purpose: OTHER

Brief 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. 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:

a) Household Survey and b) Facility assessment

1. 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..
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)
timeFrame: Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
measure: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
timeFrame: Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
measure: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)
timeFrame: Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention
measure: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9
timeFrame: Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
measure: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9
timeFrame: Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
measure: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9
timeFrame: Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
measure: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9
timeFrame: Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
measure: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9
timeFrame: Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention
Secondary outcomes:
measure: Children's weight
timeFrame: Change children's weight after one year intervention
measure: Children's height
timeFrame: Change children's height after one year intervention
measure: Children's Mid Upper Arm circumference (MUAC)
timeFrame: Change children's MUAC after one year intervention
measure: Mothers' weight
timeFrame: Change mother's weight after one year intervention
measure: Mothers' height
timeFrame: Change mother's height after one year intervention
measure: Mothers' Mid Upper Arm circumference (MUAC)
timeFrame: Change mother's Mid Upper Arm circumference (MUAC) after one year intervention
measure: Mothers' depressive symptom
timeFrame: Change mother's depression status after one year intervention
measure: Mothers' quality of life status
timeFrame: Change mother's quality of life status after one year intervention
measure: Family's monthly food security status
timeFrame: Change family's food security status after one year intervention
measure: Domestic violence (mothers)
timeFrame: Change family's domestic violence status after one year intervention
measure: Family care indicators (FCI)
timeFrame: Change of FCI after one year intervention
measure: Mothers' knowledge on parenting
timeFrame: Change of mothers' knowledge after one year intervention
Other outcomes:
measure: Family's health seeking behavior
timeFrame: Change family's health seeking behaviour status after one year intervention
measure: Family's income
timeFrame: Change family's income status after one year intervention
measure: Family's expenditure
timeFrame: Change family's expenditure status after one year intervention
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDR,B
Study officials:
References:
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