Hybrid type 1 effectiveness/implementation trial of the international Guide for Monitoring Child Development: protocol for a cluster-randomised controlled trial.
data collection
health services research
psychology
Journal
BMJ paediatrics open
ISSN: 2399-9772
Titre abrégé: BMJ Paediatr Open
Pays: England
ID NLM: 101715309
Informations de publication
Date de publication:
2021
2021
Historique:
received:
09
08
2021
accepted:
13
08
2021
entrez:
4
10
2021
pubmed:
5
10
2021
medline:
5
10
2021
Statut:
epublish
Résumé
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. 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. 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. NCT04665297, CTRI/2020/12/029748. 1.0 (12 November 2020).
Identifiants
pubmed: 34604546
doi: 10.1136/bmjpo-2021-001254
pii: bmjpo-2021-001254
pmc: PMC8444252
doi:
Banques de données
ClinicalTrials.gov
['NCT04665297']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Pagination
e001254Subventions
Organisme : NICHD NIH HHS
ID : R01 HD100984
Pays : United States
Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: No, there are no competing interests.
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