L'Office National de Nutrition (ONN)
Antananarivo, Madagascar
NCT Number: NCT05129696
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.
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Notify Me6 month–99 year
All sexes
Interventional
Not applicable
Antananarivo, 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):
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
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.
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
Time frame: Up to 12 months
Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Time frame: Up to 12 months
Monthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Time frame: Up to 12 months
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
Center for Epidemiologic Studies Depression Scale-10 (CESD-10), administered quarterly (Low: 0, High: 30, Higher scores indicate worse symptoms)
University of California, Berkeley
Other
Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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