Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo"

Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial

The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar.

Study Overview

• Status: Completed
• Conditions: Early Childhood Development
• Intervention / Treatment: Behavioral: Treatment (T); Behavioral: Treatment + (T+)

Detailed Description

This research is a cluster-randomized trial that will assess the effects of integrating early child development activities on community health worker time use and caregiver time use and participation in the program. The evaluation will compare the addition of early child development sessions to the status quo health and nutrition program, with an additional intervention arm looking at the addition of toys to the program.

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 6-30 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.

• Study Type: Interventional
• Enrollment (Actual): 8150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Madagascar
  • Antananarivo, Madagascar
    • L'Office National de Nutrition (ONN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for communities:

1. No other ECD programs present in the community or neighboring communities;
2. At least 40 children monitored at the nutrition center in the target age range of 6-30 months (monitored is defined as attending at least one growth monitoring session between July 2019 to August 2020);
3. Stable supervisory presence. Local NGOs are contracted to monitor and supervise all community health workers and help to strengthen linkages with local structures such as the community health committees and primary care facilities. Each NGO supervisor is in charge to up to 9 communities, which they visit twice a month. The investigators defined stable presence as not having had NGO turnover within the last year.

Among the communities included, children 6-30 months were eligible to participate in the intervention. There was no inclusion criteria for community health workers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (C): Status quo health and nutrition program
Experimental: Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting	Behavioral: Treatment (T); 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.
Experimental: Treatment + (T+): Enhanced play materials/activities package	Behavioral: Treatment + (T+); Caregivers/children participating to the group ECD sessions will be invited to play within a play space equipped with books, and homemade/purchased age-appropriate toys. This will be phased in after 6 months of implementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community health worker time use	Proportion of working day spent on community health worker activities, measured through recall of hourly time use using monthly phone surveys	Up to 12 months
Caregiver-child attendance in health and nutrition sessions	Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)	Up to 12 months
Caregiver-child attendance in ECD group sessions	Monthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community health worker stress	Perceived Stress Scale 4 (PSS-4) administered monthly (Low: 0, High: 16, Higher scores are correlated to more stress)	Up to 12 months
Community health worker depressive symptoms	Center for Epidemiologic Studies Depression Scale-10 (CESD-10), administered quarterly (Low: 0, High: 30, Higher scores indicate worse symptoms)	Up to 12 months

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: University of Nevada, Reno; World Bank
• Investigators: Principal Investigator: Emanuela Galasso, PhD, World Bank Group; Principal Investigator: Lia Fernald, PhD, UC Berkeley

Publications and helpful links

General Publications

• Galasso E, Ratsifandrihamanana L, Weber AM, Hemlock C, Col M, Dieci M, Rakotomalala N, Rambeloson V, Fernald LCH. Integrating early stimulation and play at scale: study protocol for "MAHAY Mikolo", a multi-arm cluster-randomized controlled trial. BMC Public Health. 2022 Feb 9;22(1):265. doi: 10.1186/s12889-022-12640-z.
• Hemlock C, Galasso E, Weber AM, Randriamiarisoa TC, Col M, Dieci M, Ratsifandrihamanana L, Fernald LCH. Integrating early child development into an existing health and nutrition program: evidence from a cluster-randomized controlled trial. BMC Public Health. 2024 Sep 27;24(1):2583. doi: 10.1186/s12889-024-20149-w.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: 2019-08-12476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with the World Bank's Open Data and Knowledge Initiative, the deidentified data collected in the study will be made publicly available at the data repository at the World Bank, which is expected to be within 24 months of the final data collection date. Metadata and critical documents (i.e. protocols and questionnaires) will conform to the standards of the Data Documentation Initiative and will be made available within one year of the end of data collection.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No