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Early Childhood Development and Parental Involvement: The role of information
Last registered on August 13, 2019

Pre-Trial

Trial Information
General Information
Title
Early Childhood Development and Parental Involvement: The role of information
RCT ID
AEARCTR-0003854
Initial registration date
August 13, 2019
Last updated
August 13, 2019 5:11 PM EDT
Location(s)

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Primary Investigator
Affiliation
Monash University
Other Primary Investigator(s)
PI Affiliation
University of Newcastle
PI Affiliation
Monash Univeristy
Additional Trial Information
Status
On going
Start date
2018-10-16
End date
2022-03-31
Secondary IDs
ACTRN12618001526268, Australia Ne Zealand Clinical Trial Registry, U1111-1219-4251, Universal Trial Number
Abstract
We use a clustered randomized controlled trial in 140 rural Bangladeshi villages to examine the effects of an intensive information campaign to educate mothers on caring of infant children. In addition to group-based monthly information sessions, mothers in a randomly selected subset of villages were provided one-to-one instructions and demonstration through fortnightly home visits. We examine the effects of such information campaign and home visits on maternal awareness and practices regarding child nutrition and feeding, hygiene, home environment, child health, maternal health as well as on child’s motor and cognitive development. The intervention would provide plausible causal pathways through which child health outcomes could be impacted, and in particular the role of knowledge and awareness in child development. Our intervention design would allow us to examine the spillover effects within households (e.g., siblings/cousins) and neighboring households.
External Link(s)
Registration Citation
Citation
Islam, Asad, Tabassum Rahman and Ummul Ruthbah. 2019. "Early Childhood Development and Parental Involvement: The role of information." AEA RCT Registry. August 13. https://doi.org/10.1257/rct.3854-1.0.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The intervention will run an information campaign with mothers on caring of children aged 1-3 years and examine the association between maternal knowledge on child development and developmental outcomes of their children in the short and medium run in a resource poor setting. This will be a randomized controlled trial (RCT) on early childhood development (ECD) implemented in southwestern rural Bangladesh. In particular, mothers who have children in this age range at present will be invited to participate in a set of three information sessions on rearing and caring of 1-3 years old children. Sessions will focus primarily on child nutrition and feeding, hygiene practice in child caring, and home environment favorable to child development.
Intervention Start Date
2018-11-16
Intervention End Date
2021-07-15
Primary Outcomes
Primary Outcomes (end points)
Primary outcomes will be measured on the following indicators, each of which are constructed using multiple variables. Construction of primary outcomes are as follows
Index A: Maternal knowledge (mother)
Variable 1: Age appropriate nutritious food
Variable 2: Balanced feeding and food safety
Variable 3: Good hygiene
Variable 4: Stimulant home environment

Index B: Maternal practice (nutrition)
Variable 1: Age appropriate nutritious food offered to child
Variable 2: Balanced feeding and food safety performed

Index C: Maternal practice (hygiene)
Variable 1: Clean house
Variable 2: Using safe water
Variable 3: Good hygiene practice
Index D: Maternal practice (Engagement with child)
Variable 1: Interaction with child
Variable 2: Investing in child

Index E: Health index (child)
Variable 1: Height-for-age (stunting), weight-for-height (wasting), weight-for-age (malnutrition)
Variable 2: Vaccination status
Variable 3: Frequency of diarrheal diseases in the last 3 months

Index F: Development index (child)
Variable 1: Cognitive development on Bayley scale III (Cognitive test)
Variable 2: Language development on Bayley scale III (Receptive and expressive communication tests)
Variable 3: Motor development on Bayley scale III (Gross and fine motor test)

The baseline survey collected data on most of these outcome variables and they are balanced across the different treatment control groups (except for the sub-index of stimulant home environment of index A and one sub-category in Index D) as is shown in Appendix C.
Primary Outcomes (explanation)
Primary outcomes will be measured on the following indicators, each of which are constructed using multiple variables. Construction of primary outcomes are as follows
Index A: Maternal knowledge (mother)
Variable 1: Age appropriate nutritious food
Variable 2: Balanced feeding and food safety
Variable 3: Good hygiene
Variable 4: Stimulant home environment

Index B: Maternal practice (nutrition)
Variable 1: Age appropriate nutritious food offered to child
Variable 2: Balanced feeding and food safety performed

Index C: Maternal practice (hygiene)
Variable 1: Clean house
Variable 2: Using safe water
Variable 3: Good hygiene practice
Index D: Maternal practice (Engagement with child)
Variable 1: Interaction with child
Variable 2: Investing in child

Index E: Health index (child)
Variable 1: Height-for-age (stunting), weight-for-height (wasting), weight-for-age (malnutrition)
Variable 2: Vaccination status
Variable 3: Frequency of diarrheal diseases in the last 3 months

Index F: Development index (child)
Variable 1: Cognitive development on Bayley scale III (Cognitive test)
Variable 2: Language development on Bayley scale III (Receptive and expressive communication tests)
Variable 3: Motor development on Bayley scale III (Gross and fine motor test)

Timeline: After one year of the start of the intervention and then finally after two years
Secondary Outcomes
Secondary Outcomes (end points)
1. Attitude towards child immunization (both targeted and older children in the households in short and medium run)
2. Pattern of health care expenditure on children (both targeted and older children in the households in short and medium run)
3. Morbidity among the younger and older children outside our target group
4. Overall health status of the younger and older children outside our target group
5. Breastfeeding practice among the younger children outside our target group.
6. Practice of breastfeeding during diarrhoea and other diseases among children aged less than 2 and half years outside our target group.
7. Immunisation status of younger and older children outside our target group.
8. Food consumption pattern among the younger and older children outside our target group.
9. Association between maternal knowledge and stunting in child in medium run (i.e. two years post intervention);
10. Association between maternal knowledge and selection of food for and feeding habit for younger child (aged 0-11 months) and/or older child aged over 3 years;
11. Assessment of child on Wechsler Primary and Preschool Scale of Intelligence (WPPI and Ages and Stages Questionnaire (ASQ) ) in order to measure IQ and motor development respectively two years post intervention.
Secondary Outcomes (explanation)
The following secondary outcomes will be measures
1) maternal knowledge and stunting in child in medium run (i.e. two years post intervention);
2) assessment of child on Wechsler Primary and Preschool Scale of Intelligence (WPPI) and Ages and Stages Questionnaire (ASQ)) in order to measure IQ and motor development respectively two years post intervention;
3) maternal knowledge and selection of food and feeding habit for younger child (aged 0-12 months) and/or older child aged over 3 years.
Therefore, the variables and indices for measuring secondary outcomes are:
Index G: Health index (child, two years post intervention)
Variable 1: Height-for-age (stunting), weight-for-height (wasting), weight-for-age (malnutrition)

Index H: Development index (two years post intervention)
Variable 1: Score on Wechsler Primary and Preschool Scale of Intelligence (WPPI)
Variable 2: Score on Ages and Stages Questionnaire (ASQ)

Index I: Maternal practice (nutrition, safe water use, vaccination, and diarrheal disease episode for child aged 0-11 months and over but <12 months)
Variable 1: Nutrition food offered to child
Variable 2: Using safe water
Variable 3: Vaccination
Variable 4: Frequency of diarrheal diseases in the last 3 months

Index J: Maternal practice (nutrition, safe water use, vaccination, and diarrheal disease episode for child aged >3 years and 10 years)
Variable 1: Nutrition food offered to child
Variable 2: Using safe water
Variable 3: Vaccination
Variable 4: Frequency of diarrheal diseases in the last 3 months


Experimental Design
Experimental Design
This intervention is running an information campaign with mothers on caring of children aged 1-3 years and examine association between maternal knowledge on child development and developmental outcomes of their children in short and medium run in the context southwestern rural Bangladesh. The intervention have been delivered in the mode of specially developed modules of brief curricula through a set of three information sessions. Mothers of children aged 1-3 years old were invited to participate in a set of three information sessions. Sessions have focused primarily on child nutrition and feeding, hygiene practice in child caring, and home environment favorable to child development. The three information sessions were followed by a refresher sessions and/or additional support through home visits at different intervention arms. Control group households were regularly invited to participate in community based cultural events and activities to encourage them to continue their participation in the project. The study intends to assess after 12 months (and again after two years) of the completion of the intervention change in maternal knowledge on targeted aspects of child caring and development; standard anthropometry i.e. height-for-age (HAZ), weight-for-age (WAZ), and weight-for-height (WHZ); attainment of motor milestone for age; attainment of motor skills; association between level of maternal knowledge in child development and developmental outcomes of children; child immunization, and health care expenditure on children.
Experimental Design Details
Not available
Randomization Method
Simple randomization were conducted on the recruited sample using the random number generator created by the statistical software, Stata (version 14).
Randomization Unit
Randomization was carried out at the village level. 140 villages were randomized into treatment and control arms. There are 80 treatment villages and 60 control villages. The treatment villages were further divided (randomly) into two groups equally- 40 villages in each treatment.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
A total of 140 village were randomized.
Sample size: planned number of observations
A total of 1802 mothers and their child aged between 1-3 years.
Sample size (or number of clusters) by treatment arms
40 villages in the Treatment arm 1;
40 villages in the Treatment arm 2; and
60 villages in the Control arm
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

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IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Monash University Human Research Ethics Committee
IRB Approval Date
2023-10-17
IRB Approval Number
(2018-16911-24520 )
Analysis Plan

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