NCT05129696

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,150 (estimated)
• Sponsor: University of California, Berkeley · Academic / Other
• Sex: All
• Age: 6 Months – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Early Childhood Development

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2021-11-22
• Last updated: 2024-02-15

Locations

1 site across 1 country: Madagascar