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A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development

NCT04665297 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2026-03-03

No results posted yet for this study

Summary

The aim of this study is to conduct a hybrid effectiveness/implementation assessment of the International Guide for Monitoring Child Development (GMCD) in two LMIC settings, India and Guatemala, within established rural CHW programs. The primary objectives are (a) to evaluate the real-world effectiveness of the GMCD; (b) to use an implementation science framework to understand barriers and facilitators to effective population coverage, provider implementation, and maintenance; (c) to conduct an economic evaluation of the GMCD.

Conditions

  • Child Development

Interventions

BEHAVIORAL

International Guide for Monitoring Child Development

Monthly GMCD visits includes assessment of risk factors, open-ended exploration of caregiver concerns about development, assessment of functioning in seven developmental domains, and using mutual problem solving strategies to develop a nurturing care plan with the caregiver.

Sponsors & Collaborators

  • Mahatma Gandhi Institute of Medical Sciences

    collaborator OTHER

  • Ummeed Child Development Center

    collaborator UNKNOWN

  • Ankara University

    collaborator OTHER

  • Wuqu' Kawoq, Maya Health Alliance

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Peter Rohloff · Assistant Professor/Associate Physician

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Guatemala
  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665297 on ClinicalTrials.gov