Clinical trial NCT05129696: Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo"
Official title: Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Early Childhood Development
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: L'Office National de Nutrition, Madagascar
name: World Bank
name: University of Nevada, Reno
First posted: 2021-11-22
Enrollment: 8150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Community health worker time use
timeFrame: Up to 12 months
measure: Caregiver-child attendance in health and nutrition sessions
timeFrame: Up to 12 months
measure: Caregiver-child attendance in ECD group sessions
timeFrame: Up to 12 months
Secondary outcomes:
measure: Community health worker stress
timeFrame: Up to 12 months
measure: Community health worker depressive symptoms
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Antananarivo
country: Madagascar
facility: L'Office National de Nutrition (ONN)
Study officials:
affiliation: World Bank Group
name: Emanuela Galasso, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Berkeley
name: Lia Fernald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.