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

NCT05129696 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8150

Last updated 2024-02-15

No results posted yet for this study

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.

Conditions

  • Early Childhood Development

Interventions

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.

Sponsors & Collaborators

  • L'Office National de Nutrition, Madagascar

    collaborator UNKNOWN

  • World Bank

    collaborator OTHER

  • University of Nevada, Reno

    collaborator OTHER

  • University of California, Berkeley

    lead OTHER

Principal Investigators

  • Emanuela Galasso, PhD · World Bank Group

  • Lia Fernald, PhD · UC Berkeley

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Madagascar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129696 on ClinicalTrials.gov