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

Phase 3

Recruiting

• Conditions: Early Childhood Development
• Interventions: Behavioral: Treatment (T); Behavioral: Treatment + (T+)

• Registration Number: NCT05129696
• Lead Sponsor: University of California, Berkeley

Brief Summary

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

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 Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting	Treatment (T)	-
Treatment + (T+): Enhanced play materials/activities package	Treatment + (T+)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

L'Office National de Nutrition (ONN); 🇲🇬 Antananarivo, Madagascar