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. 2021 Sep 15;5(1):e001254.
doi: 10.1136/bmjpo-2021-001254. eCollection 2021.

Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial

Abhishek Raut  1 , Revan Mustafayev  2 , Roopa Srinivasan  3 , Anita Chary  4 , Ilgi Ertem  5 , Maria Del Pilar Grazioso  6 , Subodh Gupta  1 , Vibha Krishnamurthy  3 , Chunling Lu  7   8 , Chetna Maliye  1 , Ann C Miller  9 , Bradley H Wagenaar  10   11 , Peter Rohloff  4   7
Affiliations

Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial

Abhishek Raut et al. BMJ Paediatr Open. .

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).

Keywords: data collection; health services research; psychology.

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Conflict of interest statement

Competing interests: No, there are no competing interests.

Figures

Figure 1
Figure 1
Schematic of study timeline and participant flow. BSID3, Bayley Scales of Infant Development, 3rd edition; GMCD, Guide for Monitoring Child Development; HOME, Home Observation for Measurement of the Environment Scale.
Figure 2
Figure 2
Description of RE-AIM dimensions and related indicators to be assessed. BSID3, Bayley Scales of Infant Development, 3rd edition; HOME, Home Observation for Measurement of the Environment Scale; RE-AIM, Reach, Effectiveness, Adoption, Implementation, Maintenance framework.
See this image and copyright information in PMC

References

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