An interventional study of Treatment (T) and Treatment + (T+) in Early Childhood Development, sponsored by University of California, Berkeley. Completed at 1 site in Madagascar. Open to participants aged 6 Months to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by University of California, Berkeley · Not applicable, Interventional, and Other
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):
University of California, Berkeley is the lead sponsor of 111 studies on the registry; 20 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Behavioral: Treatment (T)
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.
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.
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
Time frame: 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)
Time frame: 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)
Time frame: Up to 12 months
Community health worker stress
Perceived Stress Scale 4 (PSS-4) administered monthly (Low: 0, High: 16, Higher scores are correlated to more stress)
Time frame: Up to 12 months
Community health worker depressive symptoms
Center for Epidemiologic Studies Depression Scale-10 (CESD-10), administered quarterly (Low: 0, High: 30, Higher scores indicate worse symptoms)
Time frame: Up to 12 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Ran from Feb 2021 to primary completion in Mar 2025, 49 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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