Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Early Childhood Development
- Sponsor
- University of California, Berkeley
- Enrollment
- 8150
- Locations
- 1
- Primary Endpoint
- Caregiver-child attendance in ECD group sessions
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Caregiver-child attendance in ECD group sessions
Time Frame: 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
Time Frame: 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
Time Frame: Up to 12 months
Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Secondary Outcomes
- Community health worker stress(Up to 12 months)
- Community health worker depressive symptoms(Up to 12 months)