Peer-reviewed article
Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial
Abhishek V. Raut, Revan Mustafayev, Roopa Srinivasan, Anita Nandkumar Chary, İlgi Ertem et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study will test whether the international Guide for Monitoring Child Development (GMCD), an early intervention package delivered by frontline workers using mobile devices, improves developmental outcomes in children under 2 years in rural India and Guatemala. The trial will randomly assign 624 children across 52 communities to either receive the GMCD intervention plus usual care or usual care alone, measuring child development and nurturing care over 24 months. The study examines both whether the intervention works and how well it can be implemented in real-world settings in low- and middle-income countries.
Key points
- Over 40% of children under 5 in low- and middle-income countries are at risk of not reaching their developmental potential
- The GMCD is a comprehensive programme providing individualised intervention plans for young children and families with developmental difficulties
- The trial uses a cluster-randomised design with 624 children aged 0-24 months across 52 clusters in India and Guatemala
- Intervention delivered by frontline workers via digital mobile device interface for 12 months, with usual care arm crossing over for an additional 12 months
- Effectiveness measured using Bayley Scales of Infant Development and Home Observation for Measurement of the Environment Scale
Limitations
This is a protocol paper describing a planned trial, so no results or outcome data are available yet. The document cannot tell us whether the intervention actually works or how it performs in practice.
Abstract
Introduction: More than 40% of children under 5 years of age in low-income and middle-income countries are at risk of not reaching their developmental potential. The international Guide for Monitoring Child Development (GMCD) early intervention package is a comprehensive programme to address developmental difficulties using an individualised intervention plan for young children and their families. We will conduct a hybrid type 1 effectiveness-implementation evaluation of the GMCD intervention in rural India and Guatemala. Methods and analysis: Using a cluster-randomised design, 624 children aged 0-24 months in 52 clusters (26 in India, 26 in Guatemala) will be assigned to usual care or the GMCD intervention plus usual care delivered by frontline workers for 12 months. After 12 months, the usual care arm will cross over to the intervention, which will continue for 12 additional months (24 total). The intervention will be delivered using a digital mobile device interface. Effectiveness will be assessed for developmental functioning (Bayley Scales of Infant Development, 3rd edition) and nurturing care (Home Observation for Measurement of the Environment Scale) outcomes. Implementation will be assessed using the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. Explanatory qualitative analysis guided by the Consolidated Framework for Implementation Research will explore determinants between clusters with high versus low implementation effectiveness. Ethics and dissemination: The study has been approved by the Institutional Review Boards of Brigham and Women's Hospital, Mahatma Gandhi Institute of Medical Sciences and Maya Health Alliance; and by the Indian Council of Medical Research/Health Ministry Screening Committee. Key study findings will be published in international open-access journals. Trial registration number: NCT04665297, CTRI/2020/12/029748. Protocol version: 1.0 (12 November 2020).
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- International Guide for Monitoring Child Development (GMCD) early intervention package delivered by frontline workers using digital mobile device interface, providing individualised intervention plans for young children and families
- Population
- Children aged 0-24 months in rural India and Guatemala (624 children across 52 clusters)