Improving child development with results of a nimble evaluation: The Mahay Mikolo program in rural Madagascar.

Last registered on June 10, 2024

Pre-Trial

Trial Information

General Information

Title
Improving child development with results of a nimble evaluation: The Mahay Mikolo program in rural Madagascar.
RCT ID
AEARCTR-0004704
Initial registration date
November 15, 2019

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
November 20, 2019, 3:00 PM EST

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

Last updated
June 10, 2024, 4:49 PM EDT

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

Locations

Region

Primary Investigator

Affiliation
UC Berkeley

Other Primary Investigator(s)

PI Affiliation
UC Berkeley
PI Affiliation
World Bank Group
PI Affiliation
University of Nevada - Reno
PI Affiliation
Catholic University of Madagascar

Additional Trial Information

Status
Completed
Start date
2021-02-08
End date
2022-05-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
The goal of this study is to assess the feasibility of implementing a group-based early-child-development curriculum through the existing platform of government-run community-based health and nutrition. This research is a cluster-randomized trial that will assess the effects of integrating ECD activities on community health worker time use and caregiver time use and participation in the program.

The evaluation will compare:
• C: Status quo health and nutrition program
• T: Status quo health and nutrition program + ECD group sessions
• T+: Status quo health and nutrition program + ECD group sessions + enhanced play materials/activities package.

This study has four objectives, which will be measured at the community health worker level, and at the caregiver level for caregiver-child dyads (where children are between 6-36 months old at time of intervention launch):
1. Measure how the integration of ECD activities with standard nutrition programming affects the time and task allocation of the community health workers
2. Measure the extent, if any, that the addition of ECD activities crowds out community health worker health/nutrition tasks that are part of the standard community program
3. Measure how the integration of ECD activities affects rates of caregiver participation in nutrition and health activities over time (e.g., during changes in seasonal activities).
4. Measure the impact of enhanced availability and maintenance of age-appropriate play materials/activities on sustained caregiver participation rates in the program.
External Link(s)

Registration Citation

Citation
Fernald, Lia et al. 2024. "Improving child development with results of a nimble evaluation: The Mahay Mikolo program in rural Madagascar.." AEA RCT Registry. June 10. https://doi.org/10.1257/rct.4704-4.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
T: The intervention arm includes an adaption of the Jamaica Reach Up and Learn home visiting program to a group setting.
The target population are children aged 6-30 months old registered in the community health and nutrition intervention. Children area offered to participate in bimonthly group sessions. Each session will have materials and activities appropriate for children spanning a 6-month range (6-12 m, 12-18 m, 12-24 m, 24-30 m) and can accommodate a maximum of 10 children per age group. If more households are interested than can be accommodated by the program, interested families will be randomly selected for participation. A total of 40 children per site will be able to participate in the ECD activities at any one time. With bi-monthly meetings, each child will be exposed to 12 sessions for each age group, and is eligible to transition to the next.

T+ enhanced play materials/activities package. Caregivers/children participating to the group ECD sessions will be invited to pay within a play space equipped with books, and homemade/purchased age-appropriate toys. The making and maintenance of the toys and materials will be supported by volunteers’ scouts youth groups, who have a capillary presence in the country. This T+ intervention will be phased in after 6 months of implementation.
Intervention Start Date
2021-02-15
Intervention End Date
2022-03-15

Primary Outcomes

Primary Outcomes (end points)
Community health worker time use and workplace productivity.
Caregiver participation rates in group-based health/nutrition activities and early child development programs.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The nimble evaluation will test the value added and the feasibility of integrating ECD group activities (T) onto a standard of care maternal and child health and nutrition community-based program (C).

There are 75 sites that will comprise the study sample. For the first six months, 50 of the 75 sites will be randomly assigned to the enhanced nutrition program that will include group-based early child stimulation activities (T). For the second six months, the 50 sites in the treatment group (T) will be randomly assigned to either continue with the enhanced group sessions (T), or receive an group sessions and an enhanced play materials/activities package (T+).

Monthly administrative data on caregiver participation, and surveys eliciting information on community health worker time use and productivity will be collected throughout the implementation period.
Experimental Design Details
Randomization Method
Randomization of sites to treatment arms will be done by research staff remotely using computer software.
Randomization Unit
Site-level randomization
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
75 sites, stratified by region, remoteness, size of the target population and baseline prevalence of underweight/stunting)
Sample size: planned number of observations
150 community health workers (assuming 2 per site) 6000 caregiver/children eligible dyads (assuming an average of 80 children aged 6-30 registered in the administrative data per site).
Sample size (or number of clusters) by treatment arms
C: 25 sites status-quo government health/nutrition program
T: 25 sites health/nutrition program + group ECD sessions ;
T+: 25 sites health/nutrition program + group ECD sessions + enhanced play materials/activities.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
UC Berkeley Center for the Protection of Human Subjects
IRB Approval Date
2020-02-10
IRB Approval Number
2019-08-12476

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
March 20, 2022, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
May 23, 2022, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
75 villages
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
149 community health workers
Final Sample Size (or Number of Clusters) by Treatment Arms
49 community health workers control, 50 community health workers T, 50 community health workers T+
Data Publication

Data Publication

Is public data available?
No

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Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials