Integrating early child development activities into community health programs in Madagascar
Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial
PHASE3 · University of California, Berkeley · NCT05129696
This study tests if adding early child development activities to community health programs in Madagascar helps caregivers get more involved and improves how health workers use their time.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 8150 (estimated) |
| Ages | 6 Months to 99 Years |
| Sex | All |
| Sponsor | University of California, Berkeley (other) |
| Locations | 1 site (Antananarivo) |
| Trial ID | NCT05129696 on ClinicalTrials.gov |
What this trial studies
This research examines the effects of incorporating early child development (ECD) group sessions into existing community health and nutrition programs in Madagascar. It is a cluster-randomized trial that evaluates how these ECD activities influence the time use of community health workers and caregiver participation. The study compares the integration of ECD sessions with standard health and nutrition programming, including an additional focus on the impact of providing toys. The objectives include measuring changes in task allocation, caregiver participation rates, and the effects of play materials on engagement.
Who should consider this trial
Good fit: Ideal candidates for this study are communities in Madagascar with children aged 6-30 months and no existing ECD programs.
Not a fit: Patients in communities that already have established early childhood development programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early childhood development outcomes and improve caregiver engagement in health and nutrition programs.
How similar studies have performed: Other studies have shown success in integrating early childhood development activities into health programs, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for communities: 1. No other ECD programs present in the community or neighboring communities; 2. 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); 3. 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.
Where this trial is running
Antananarivo
- L'Office National de Nutrition (ONN) — Antananarivo, Madagascar (RECRUITING)
Study contacts
- Principal investigator: Emanuela Galasso, PhD — World Bank Group
- Study coordinator: Lia Fernald, PhD
- Email: fernald@berkeley.edu
- Phone: (510) 643-9113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Early Childhood Development