Integrating Early Stimulation and Play at Scale: MAHAY Mikolo

Study Overview
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Brief Summary
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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.

Detailed Description
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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): Measure how the integration of ECD activities with standard nutrition programming affects the time and task allocation of the community health workers 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 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). Measure the impact of enhanced availability and maintenance of age-appropriate play materials/activities on sustained caregiver participation rates in the program.

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

Conditions
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Early Childhood Development

Intervention / Treatment
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* Behavioral: Treatment (T)
* Behavioral: Treatment + (T+)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for communities: No other ECD programs present in the community or neighboring communities; 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); 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (C): Status quo health and nutrition program<br> | |
| Experimental: Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting<br> | Behavioral: Treatment (T)<br>* 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.<br>|
| Experimental: Treatment + (T+): Enhanced play materials/activities package<br> | Behavioral: Treatment + (T+)<br>* 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.<br>|

What is the study measuring?
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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 |