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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Child Development
• Intervention / Treatment: Behavioral: International Guide for Monitoring Child Development

Detailed Description

Specific Aim 1: Assess the effectiveness of the GMCD intervention to improve developmental outcomes and nurturing care in India and Guatemala. The investigators will conduct a parallel-arm cluster randomized trial within rural CHW programs. In the primary effectiveness phase, children under 2 years old will receive the GMCD intervention or control for 12 months. Subsequently, control clusters will cross into the intervention, and continue an additional 12 months (total 24 study months). The primary developmental effectiveness outcome will be change in age-adjusted scores at 12 months on the Bayley Scales of Infant Development, 4th Edition BSID4) (3). The secondary nurturing care effectiveness outcome will be change in mean Home Observation for Measurement of the Environment (HOME) score at 12 months (4).

Specific Aim 2: Assess barriers and facilitators to GMCD implementation using the RE-AIM evaluation framework (5). RE-AIM domains will be assessed as: (a) Reach: participation rates, comparison of participant/non-participant characteristics, attendance/drop-out; (b) Effectiveness: impact on development (BSID4) and nurturing environment (HOME) [in Aim 1]; (c) Adoption: proportion of workers/facilities participating, CHW characteristics; (d) Implementation: contact hours/visit completion, fidelity to delivery protocols; (e) Maintenance: patient outcomes and cost effectiveness analysis at 12-24 months [in Aim 3]; intent by decision makers and implementers to continue intervention. In addition, the investigators will conduct a sequential quantitative-->qualitative explanatory analysis, using interviews and focus groups with implementers from clusters with highest/lowest impact outcomes (BSID4/HOME) to explore institutional inner and outer setting and implementation processes associated with intervention success, using the Consolidated Framework for Implementation Research (CFIR).

Specific Aim 3: Conduct an economic evaluation of the GMCD intervention. Evaluation will assess (a) costs of the interventions at 12 and 24 months; and (b) cost-effectiveness of the intervention (dollar per unit increase in BSID or HOME scores) at 12 months. This analysis will provide cost information to policymakers to help guide resource allocation decisions for ECD interventions.

• Study Type: Interventional
• Enrollment (Estimated): 624
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Rohloff; Phone Number: 617-447-3034; Email: prohloff@bwh.harvard.edu

Study Locations

• Guatemala
  • Tecpán Guatemala, Guatemala
    • Recruiting
    • Wuqu' Kawoq
    • Contact: Peter Rohloff; Email: peter@wuqukawoq.org
• India
  • Maharashtra
    • Sevagram, Maharashtra, India
      • Not yet recruiting
      • Mahatma Gandhi Institute of Medical Sciences
      • Contact: Subodh Gupta; Email: subodh@mgims.ac.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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; 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.
No Intervention: Control Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score	Raw score range 0-45, higher scores better	Change from 0 to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score	Raw score range 0-45, higher scores better	Change from 0 to 24 months
Change in Composite Language Score at 24 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153	Change from 0 to 24 months
Change in Composite Motor Score at 24 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154	Change from 0 to 24 months
Change in Composite Cognitive Score at 24 months	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145	Change from 0 to 24 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Harvard Medical School (HMS and HSDM); University of Washington; Ankara University; Mahatma Gandhi Institute of Medical Sciences; Wuqu' Kawoq, Maya Health Alliance; Ummeed Child Development Center
• Investigators: Principal Investigator: Peter Rohloff, Assistant Professor/Associate Physician

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: India; Guatemala; Early Child Development
• Other Study ID Numbers: 2020P002143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will deposit the above data in the Harvard Dataverse (https://dataverse.harvard.edu/) or another suitable public data repository, and it will be freely available there for any researcher wishing to perform secondary analysis, confirmation of primary study findings, or meta-analysis who adheres to the existing policy and procedures of the repository.
• IPD Sharing Time Frame: We 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.
• IPD Sharing Access Criteria: Publically available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No