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Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo"

Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05129696
Enrollment
8150
Registered
2021-11-22
Start date
2021-02-01
Completion date
2025-03-31
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Development

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.

Interventions

BEHAVIORALTreatment (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.

BEHAVIORALTreatment + (T+)

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.

Sponsors

University of California, Berkeley
Lead SponsorOTHER
University of Nevada, Reno
CollaboratorOTHER
World Bank
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Masking description

The investigators that are analyzing the data are blinded to treatment assignment during analysis.

Eligibility

Sex/Gender
ALL
Age
6 Months to 99 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Community health worker time useUp to 12 monthsProportion 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 sessionsUp to 12 monthsMonthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Caregiver-child attendance in ECD group sessionsUp to 12 monthsMonthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)

Secondary

MeasureTime frameDescription
Community health worker stressUp to 12 monthsPerceived Stress Scale 4 (PSS-4) administered monthly (Low: 0, High: 16, Higher scores are correlated to more stress)
Community health worker depressive symptomsUp to 12 monthsCenter for Epidemiologic Studies Depression Scale-10 (CESD-10), administered quarterly (Low: 0, High: 30, Higher scores indicate worse symptoms)

Countries

Madagascar

Contacts

PRINCIPAL_INVESTIGATOREmanuela Galasso, PhD

World Bank Group

PRINCIPAL_INVESTIGATORLia Fernald, PhD

UC Berkeley

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026