Evidence map›Paper›PMID 34604546›Full record

ArticleBMJ paediatrics open2021

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

Abhishek Raut, Revan Mustafayev, Roopa Srinivasan, Anita Chary, Ilgi Ertem, Maria Del Pilar Grazioso, Subodh Gupta, Vibha Krishnamurthy, Chunling Lu, Chetna Maliye and 3 more

Registry-linked trialOpen access · diamondAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ paediatrics open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04665297 (An Individualized Approach to Promote Nurturing Care in Low and Middle Income Countries), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04665297 naactive not recruitingnot on this mapstarted 2023, after this paper: background citation

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

TypeinterventionalSponsorBrigham and Women's HospitalRan2023 to 2026Enrolled624ConditionsChild DevelopmentArmsInternational Guide for Monitoring Child Development
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 3 countries.

Abhishek RautDepartment of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra, India.ORCID 0000-0001-5671-5329
Revan MustafayevDepartment of Pediatrics, Acibadem Maslak Private Hospital, Istanbul, Turkey.ORCID 0000-0003-1065-684X
Roopa SrinivasanUmmeed Child Development Center, Mumbai, Maharashtra, India.ORCID 0000-0001-9268-7396
Anita CharyCenter for Indigenous Health Research, Wuqu' Kawoq | Maya Health Alliance, Tecpán, Chimaltenango, Guatemala.
Ilgi ErtemDevelopmental-Behavioral Pediatrics Division, Department of Pediatrics, Faculty of Medicine, Ankara University, Ankara, Turkey.ORCID 0000-0001-9187-0869
Maria Del Pilar GraziosoProyecto Aigle, Guatemala, Guatemala.
Subodh GuptaDepartment of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra, India.ORCID 0000-0002-4412-9389
Vibha KrishnamurthyUmmeed Child Development Center, Mumbai, Maharashtra, India.
Chunling LuDivision of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-4780-9451
Chetna MaliyeDepartment of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra, India.
Ann C MillerGlobal Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-6841-9439
Bradley H WagenaarDepartment of Global Health, University of Washington, Seattle, Washington, USA.
Peter RohloffCenter for Indigenous Health Research, Wuqu' Kawoq | Maya Health Alliance, Tecpán, Chimaltenango, Guatemala.ORCID 0000-0001-7274-8315
Mahatma Gandhi Institute of Medical Sciences · INBrigham and Women's Hospital · USAcıbadem University · TRAnkara University · TRHarvard University · USUniversity of Washington · US

Funding

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 DevelopmentR01HD100984 · NICHD · BRIGHAM AND WOMEN'S HOSPITAL · PI ROHLOFF, PETER · 2021 to 2025
$2.5M
NICHD NIH HHS R01 HD100984
6 · The paper itself

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).

Indexed as

FamilyRural PopulationChildChild DevelopmentChild, PreschoolFemaleHumansIndiaInfantInfant, NewbornPovertyRandomized Controlled Trials as Topicdata collectionhealth services researchpsychology

Identifiers

PMID34604546
PMCPMC8444252
OpenAlexW3198960997

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.