Maternal Beliefs, Mental Health, and Economic Resources on Human Capital Accumulation in Early Life

Last registered on July 20, 2024

Pre-Trial

Trial Information

General Information

Title
Maternal Beliefs, Mental Health, and Economic Resources on Human Capital Accumulation in Early Life
RCT ID
AEARCTR-0012108
Initial registration date
September 28, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 04, 2023, 4:44 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
July 20, 2024, 4:22 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Region

Primary Investigator

Affiliation
University of Sydney

Other Primary Investigator(s)

PI Affiliation
University of Melbourne
PI Affiliation
American University

Additional Trial Information

Status
In development
Start date
2023-09-01
End date
2024-12-31
Secondary IDs
ACTRN12623000659606
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Using a novel locally grown health service delivery model in Bangladesh that tracks the universe of newly married couples and connects them to local health services, we aim to study whether targeting mothers early in pregnancy with three complementary interventions -- individually or in combination -- can improve their own wellbeing as well as their children’s developmental outcomes. Our outcomes of interest include women’s empowerment, parental inputs, physical and mental health, and children’s health and development.
External Link(s)

Registration Citation

Citation
Baranov, Victoria, Shyamal Chowdhury and Valentina Duque. 2024. "Maternal Beliefs, Mental Health, and Economic Resources on Human Capital Accumulation in Early Life." AEA RCT Registry. July 20. https://doi.org/10.1257/rct.12108-1.1
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Experimental Details

Interventions

Intervention(s)
We will have a single control group, and three treatment groups. Villages will be assigned to one these groups (see Sections ‘Experimental Design’ and ‘Experiment Characteristics’ below for details). Treatment households will receive information. Additional intervention includes psychological counselling in group sessions, which will be cross-randomized.
Intervention (Hidden)
The study will provide three interventions through the Kapasia Model of Maternal and Child Health (henceforth, Kapasia Model):
In treatment 1, project officers employed by the research team, who will be located in study area, will provide information over the phone to each treated household on their eligibility (yes or no) of government's cash and food transfer programs, as well as where and how to enrol, and assistance with enrolment for eligible mothers.

Treatment 2 involves providing information to pregnant mothers and their families on the importance of the early-life environment, and especially the 9-months in utero period, in laying the foundations for a child's lifelong success. Eligible and willing participants who would be randomly assigned to receive this treatment will be contacted by our project officers, and will provide the information over the phone.

The third intervention involves offering psychological counselling based on Cognitive Behavioural Therapy, which will be provided by trained counsellors from Moner Bondhu (https://www.monerbondhu.org/). The content will follow the World Health Organization (WHO)-adopted and evidence-based programme called Thinking Healthy, specifically focusing on only the early (pre-delivery) sessions. Thinking Healthy has already been translated and adapted to Bengali. Eligible and willing participants who would be randomly assigned to receive this treatment will be contacted by an officer from Moner Bondhu. Participants will be invited to take part in 4 to 6 group counselling sessions, each lasting approximately 1-1.5 hours. The group will consist of other pregnant women from the same village enrolled in this study.
Intervention Start Date
2023-10-01
Intervention End Date
2024-12-31

Primary Outcomes

Primary Outcomes (end points)
We will measure women’s empowerment, parental investment, mother’s physical and mental health, IPV, and child’s physical health and cognitive and socio-emotional development.
Primary Outcomes (explanation)
Women’s empowerment (women’s agency in fertility planning, personal expenditures and expenditures on children, children and household investment decisions, savings accounts, and participation in social programs and local leaderships); Women’s beliefs (about importance of early life conditions, self-efficacy in parenting, beliefs about modifiability of child skills); Parental Investment (time, monetary, and warmth); Physical health (self-reported physical health, body-mass index, and mid-upper arm circumference (MUAC)); Mental health (PHQ-9 a screener for depression, GAD-7 a screener for anxiety); IPV; and Stress (Cohen Stress Scale, Biomarkers of stress using hair samples. We plan to collect biomarkers of stress from mothers and their infants. Using hair samples, we can extract HPA axis hormones such as cortisol. Hair-derived biomarker measurement indicates HPA axis activity over the course of months (analytes in each centimeter of hair approximate hormone secretion over one month), and thus more accurately reflect chronic hormone secretion (see Baranov et al. 2022 for a discussion and an example of successful hair cortisol measurement with mother and child dyads in Pakistan). Hair sample collection will be funded with this proposal but further funding will be sought for laboratory extraction of analytes. Hair samples are easily storable and stable for 1-2 years.

Secondary Outcomes

Secondary Outcomes (end points)
Health at birth (birth weight and low birth weight); Developmental outcomes (Bayley Scales of Infant and Toddler Development that captures children’s cognitive, language, motor, adaptive); Health (weight-for-length, length-for-age, acute respiratory illnesses); Stress (Biomarkers of stress from hair samples).
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We will have two information treatments and a single control group, consisting of 40, 40, 40 villages, respectively. In addition, a psychological counselling treatment will be cross-randomized with the information interventions (for details, see section "Intervention" above).
Experimental Design Details
To evaluate the impact of these three interventions, we will conduct a RCT across in Kapasia sub-district in Bangladesh. The two information interventions will be cross-randomized with the one mental health intervention. The mental health intervention will be randomized at the Union Health and Family Welfare Centre (UHFWC) level (there are 10 total UHFWCs) and allocated at a 1:1 ratio. We will then randomly select 120 villages, stratified by UHFWC, to participate. The information interventions will be randomized at the village level, stratified by UHFWC, with 40 villages receiving information and enrollment support for government programs, 40 villages receiving additional information on the importance of early life conditions, and 40 control (no information) villages. Eligible participants will be pregnant women and mothers with young children aged 6 months or younger. We will aim to recruit 22 women per village to be part of the study sample.
We will use two types of data, (i) the data from the digital information system, which we call administrative data, and (ii) household and individual survey data including elicitation of maternal beliefs of prospective and existing mothers that we will collect as a part of the study, which we call household survey data. This survey will be conducted on the sample of 22 women per village for a total sample of 2,640 women. The administrative data include information (e.g., age, education, occupation, mobile phone number, pregnancy status, blood group, birth outcomes, number of children) on all registered newly married couples in our study area, including the 22 women per village in our study sample, and will identify key outcomes such as pregnancy status and birth outcomes. We will conduct a baseline survey with an endline 10 months later, and we plan to conduct a midline survey by phone (which will likely be funded using internal funds from the University of Sydney and University of Melbourne) to measure parental inputs in the in utero period.
Randomization Method
Randomization will be conducted in office by a computer.
Randomization Unit
Two-step randomization: first villages will be assigned to treatment and control groups. Second, treatment villages were further assigned to receive information treatment or information plus psychological counselling treatments.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
120 villages
Sample size: planned number of observations
2,640
Sample size (or number of clusters) by treatment arms
1. Information plus enrolment support: 40 villages, 22 households from each villages, 880 households in total.
2. Information on the importance of early life conditions: 40 villages, 22 households from each villages, 880 households in total.
3. Psychological counselling: 20 villages from treatment 1 and 20 villages from treatment 2, 880 households in total
4. Control group: 40 villages, 22 households from each villages, 880 households in total.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Given the sample sizes above and accounting for the varied clustered design, we would be powered to detect a Minimum Detectable Effect (MDE) size of 0.31 of a standard deviation (SD) change for the mental health intervention (randomized at the Health Centre (UHFWC) level with the conservative estimate of 20 centers). For the information arms, we would be powered to detect a 0.19SD change for either of the information interventions (main effects only). As benchmark for the MDEs on mental health interventions, Rahman et al. (2008) found that a mental health intervention similar to the one proposed here improved mothers’ mental health by 0.70SD, while Sikander et al. (2019) found that a more scalable, peer-delivered version of the intervention increased mothers’ mental health by 0.30SD. A tele-counseling intervention in Bangladesh improved mental health by 0.65SD (Vlassopolous et al. (2021)).
IRB

Institutional Review Boards (IRBs)

IRB Name
The University of Sydney Human Research Ethics Committee
IRB Approval Date
2023-03-15
IRB Approval Number
2023/004
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials