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

NCT05129696 | Recruiting Phase 3

• 1 other identifier: 2019-08-12476
• Study Type: interventional
• Target: 8,150
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Development

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Community health worker stress

  Up to 12 months

• Community health worker depressive symptoms

  Up to 12 months

Study Arms (3)

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

Behavioral: Treatment (T)

Treatment + (T+): Enhanced play materials/activities package

EXPERIMENTAL

Behavioral: Treatment + (T+)

Interventions

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.

Treatment + (T+): Enhanced play materials/activities package

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• No other ECD programs present in the community or neighboring communities;
• 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);
• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead
• L'Office National de Nutrition, Madagascar: collaborator
• World Bank: collaborator
• University of Nevada, Reno: collaborator

Study Sites (1)

L'Office National de Nutrition (ONN)

Antananarivo, Madagascar

RECRUITING

Related Publications (2)

• 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.

  PMID: 39334156 DERIVED

• 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.

  PMID: 35139822 DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

• Emanuela Galasso, PhD

  World Bank Group

  PRINCIPAL INVESTIGATOR

• Lia Fernald, PhD

  UC Berkeley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lia Fernald, PhD

CONTACT

(510) 643-9113; fernald@berkeley.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators that are analyzing the data are blinded to treatment assignment during analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 22, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

MA (1)