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

• Published in: BMJ paediatrics open Vol. 5; no. 1; p. e001254
• Main Authors: Raut, Abhishek, Mustafayev, Revan, Srinivasan, Roopa, Chary, Anita, Ertem, Ilgi, Grazioso, Maria del Pilar, Gupta, Subodh, Krishnamurthy, Vibha, Lu, Chunling, Maliye, Chetna, Miller, Ann C, Wagenaar, Bradley H, Rohloff, Peter
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd 15.09.2021; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Age; Caregivers; Child; Child Development; Child, Preschool; Children & youth; Data collection; Family; Female; Focus groups; health services research; Humans; India; Infant; Infant, Newborn; Pediatrics; Poverty; Protocol; psychology; Qualitative research; Randomized Controlled Trials as Topic; Rural areas; Rural Population; Workers; India; Guatemala; psychology; health services research; data collection
• ISSN: 2399-9772; 2399-9772
• DOI: 10.1136/bmjpo-2021-001254

IntroductionMore 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 analysisUsing 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 disseminationThe 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 numberNCT04665297, CTRI/2020/12/029748.Protocol version1.0 (12 November 2020).