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| Name | Class |
|---|---|
| University of Nevada, Reno | OTHER |
| World Bank | OTHER |
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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.
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (C): Status quo health and nutrition program | No Intervention | ||
| Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting | Experimental |
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| Treatment + (T+): Enhanced play materials/activities package | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment (T) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Community health worker time use | Proportion of working day spent on community health worker activities, measured through recall of hourly time use using monthly phone surveys | Up to 12 months |
| Caregiver-child attendance in health and nutrition sessions | Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended) | Up to 12 months |
| Caregiver-child attendance in ECD group sessions | Monthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended) | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Community health worker stress | Perceived Stress Scale 4 (PSS-4) administered monthly (Low: 0, High: 16, Higher scores are correlated to more stress) | Up to 12 months |
| Community health worker depressive symptoms |
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Inclusion Criteria for communities:
Among the communities included, children 6-30 months were eligible to participate in the intervention. There was no inclusion criteria for community health workers.
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| Name | Affiliation | Role |
|---|---|---|
| Emanuela Galasso, PhD | World Bank Group | Principal Investigator |
| Lia Fernald, PhD | UC Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L'Office National de Nutrition (ONN) | Antananarivo | Madagascar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39334156 | Derived | Hemlock C, Galasso E, Weber AM, Randriamiarisoa TC, Col M, Dieci M, Ratsifandrihamanana L, Fernald LCH. Integrating early child development into an existing health and nutrition program: evidence from a cluster-randomized controlled trial. BMC Public Health. 2024 Sep 27;24(1):2583. doi: 10.1186/s12889-024-20149-w. | |
| 35139822 | Derived |
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In accordance with the World Bank's Open Data and Knowledge Initiative, the deidentified data collected in the study will be made publicly available at the data repository at the World Bank, which is expected to be within 24 months of the final data collection date. Metadata and critical documents (i.e. protocols and questionnaires) will conform to the standards of the Data Documentation Initiative and will be made available within one year of the end of data collection.
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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The investigators that are analyzing the data are blinded to treatment assignment during analysis.
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| Treatment + (T+) | Behavioral | 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. |
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Center for Epidemiologic Studies Depression Scale-10 (CESD-10), administered quarterly (Low: 0, High: 30, Higher scores indicate worse symptoms)
| Up to 12 months |
| Galasso E, Ratsifandrihamanana L, Weber AM, Hemlock C, Col M, Dieci M, Rakotomalala N, Rambeloson V, Fernald LCH. Integrating early stimulation and play at scale: study protocol for "MAHAY Mikolo", a multi-arm cluster-randomized controlled trial. BMC Public Health. 2022 Feb 9;22(1):265. doi: 10.1186/s12889-022-12640-z. |