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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Child Development

Intervention / Treatment
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* Behavioral: International Guide for Monitoring Child Development


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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<br>* 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.<br>|
| No Intervention: Control Arm<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guatemala, India, Early Child Development