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

StatusCompleted
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital Show 8 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Apr 30, 2026 to Feb 28, 2026
    • Enrollment target: estimated 624 to confirmed 626
    • Study description revised
    • Site details revised at 1 of 2 sites
    • Collaborators: details revised at 1 of 6 entries
    • Publications: details revised at 3 of 3 entries
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Study description revisedv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 1, 2023 to Jan 17, 2023
    v4
  2. Start date: Jan 1, 2022 to Jan 1, 2023v3
  3. Start date: May 1, 2021 to Jan 1, 2022v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04665297
Lead Sponsor Brigham and Women's Hospital
Collaborators: Mahatma Gandhi Institute of Medical Sciences, Ummeed Child Development Center, Ankara University, Wuqu' Kawoq, Maya Health Alliance, Harvard Medical School (HMS and HSDM), University of Washington
Conditions
(from sponsor)		 Child Development
Enrollment 626 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov