Evaluating a guide for monitoring child development in rural India and Guatemala
Official title: An Individualized Approach to Promote Nurturing Care in Low and Middle Income Countries: a Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development
Run by Brigham and Women's Hospital · NCT04665297 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new guide to help monitor child development in rural areas of India and Guatemala to see if it can improve outcomes for children under 2 years old.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Months to 24 Months |
| Sex | All |
| Enrollment | 624 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Tecpán Guatemala and 1 other locations) |
| Trial ID | NCT04665297 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 0-24 months receiving health services from designated frontline health workers in Guatemala or India.
✕Probably not a fit
Children who are critically ill or whose caregivers do not provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness and implementation of the International Guide for Monitoring Child Development (GMCD) in rural settings of India and Guatemala. It involves a parallel-arm cluster randomized trial where children under 2 years old will receive either the GMCD intervention or a control for 12 months, followed by a crossover for control clusters. The study will evaluate developmental outcomes using the Bayley Scales of Infant Development and nurturing care through the Home Observation for Measurement of the Environment. Additionally, it will explore barriers and facilitators to implementation using the RE-AIM framework.
Why it matters
Potential benefit: If successful, this study could significantly improve early child development outcomes in low- and middle-income countries.
How similar studies have gone: Previous studies have shown promise in similar approaches to improving child development outcomes, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 0-24 months at the time of enrollment visit * receiving health services from frontline health workers of Maya Health Alliance (Guatemala), Mahatma Gandhi Institute (India) or their local partners Exclusion Criteria: * children who are critically ill and are judged by the frontline health worker to require hospitalization or center-based care * children whose caregivers do not provide informed consent for the study
Where it's running
-
Wuqu' Kawoq
Tecpán Guatemala, Guatemala Recruiting -
Mahatma Gandhi Institute of Medical Sciences
Sevagram, Maharashtra, India Not yet recruiting
Study contacts
- Principal investigator: Peter Rohloff — Assistant Professor/Associate Physician
- Study coordinator: Peter Rohloff
- Email: prohloff@bwh.harvard.edu
- Phone: 617-447-3034
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.