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Simple monthly Check-Ins could boost Kids' development in poor regions

NCT ID NCT04665297

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a personalized approach to monitor and support child development in rural India and Guatemala. Over 600 children under 2 years old receive monthly visits from community health workers who assess development and help caregivers create nurturing care plans. The goal is to see if this low-cost program improves language, motor, and cognitive skills compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
International Guide for Monitoring Child Development (GMCD) – a behavioral intervention using monthly visits and caregiver guidance
What this could lead to
If successful, this could provide a low-cost, scalable way to support early childhood development in low-resource settings.
What could go wrong
This is an implementation study, not a treatment trial. Results may vary across communities, and improvements may be modest or hard to sustain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 624 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 24 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Child development

Contacts and locations

Locations

  • Mahatma Gandhi Institute of Medical Sciences

    Sevāgrām, Maharashtra, India

  • Wuqu' Kawoq

    Tecpán Guatemala, Guatemala

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