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

Early Childhood Development Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Early Childhood Development

• NCT number: NCT05129696
• Study type: Interventional
• Source: University of California, Berkeley
• Contact: Lia Fernald, PhD
• Phone: (510) 643-9113
• Email: fernald@berkeley.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2021
• Completion date: March 2025