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

NCT04665297 | Active Not Recruiting

• 1 other identifier: 2020P002143
• Study Type: interventional
• Target: 624
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Guatemala; India; Early Child Development

Outcome Measures

Primary Outcomes (3)

• Change in Composite Language Score at 12 months

  Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153

  Change from 0 to 12 months

• Change in Composite Motor Score at 12 months

  Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154

  Change from 0 to 12 months

• Change in Composite Cognitive Score at 12 months

  Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145

  Change from 0 to 12 months

Secondary Outcomes (1)

• Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score

  Change from 0 to 12 months

Other Outcomes (4)

• Change in Composite Language Score at 24 months

  Change from 0 to 24 months

• Change in Composite Motor Score at 24 months

  Change from 0 to 24 months

• Change in Composite Cognitive Score at 24 months

  Change from 0 to 24 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Subjects from intervention clusters will receive the GMCD intervention, delivered in monthly visits to the home by frontline health workers, for 24 months. 0-12 months represents the primary effectiveness study, and 12-24 months a secondary maintenance study.

Behavioral: International Guide for Monitoring Child Development

Control Arm

NO INTERVENTION

Subjects in control clusters will continue to receive usual care from their frontline health workers. After 12 months (primary effectiveness study) control will cross into the intervention for months 12-24.

Interventions

International Guide for Monitoring Child Development BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuqu' Kawoq, Maya Health Alliance: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University of Washington: collaborator
• Mahatma Gandhi Institute of Medical Sciences: collaborator
• Ummeed Child Development Center: collaborator
• Ankara University: collaborator
• Brigham and Women's Hospital: lead

Study Sites (2)

Wuqu' Kawoq

Tecpán Guatemala, Guatemala

Location

Mahatma Gandhi Institute of Medical Sciences

Sevāgrām, Maharashtra, India

Location

Related Publications (3)

• Ertem IO, Krishnamurthy V, Mulaudzi MC, Sguassero Y, Balta H, Gulumser O, Bilik B, Srinivasan R, Johnson B, Gan G, Calvocoressi L, Shabanova V, Forsyth BWC. Similarities and differences in child development from birth to age 3 years by sex and across four countries: a cross-sectional, observational study. Lancet Glob Health. 2018 Mar;6(3):e279-e291. doi: 10.1016/S2214-109X(18)30003-2.

  PMID: 29433666 BACKGROUND

• Ertem IO, Dogan DG, Gok CG, Kizilates SU, Caliskan A, Atay G, Vatandas N, Karaaslan T, Baskan SG, Cicchetti DV. A guide for monitoring child development in low- and middle-income countries. Pediatrics. 2008 Mar;121(3):e581-9. doi: 10.1542/peds.2007-1771.

  PMID: 18310178 BACKGROUND

• Raut A, Mustafayev R, Srinivasan R, Chary A, Ertem I, Grazioso MDP, Gupta S, Krishnamurthy V, Lu C, Maliye C, Miller AC, Wagenaar BH, Rohloff P. Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial. BMJ Paediatr Open. 2021 Sep 15;5(1):e001254. doi: 10.1136/bmjpo-2021-001254. eCollection 2021.

  PMID: 34604546 DERIVED

Study Officials

• Peter Rohloff

  Assistant Professor/Associate Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given nature of study, blinding is not feasible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/Associate Physician

Model Details: Nonblinded, two-arm cluster randomized controlled trial for 12 months. At 12 months, control arm crosses into the intervention, and both arms receive the intervention for an additional 12 months (total of 24 months)

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 11, 2020
• Study Start: January 17, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Investigators will submit data sets to the repository no later than 3 years after completion of final patient follow-up, or 2 years after the publication of the main study paper, whichever comes first.
• Access Criteria: Publically available

Locations

GU (1); IN (1)