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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Study protocol

Assessing the effect of an educational intervention on early childhood development among Mexican preschool children in the state of Oaxaca: a study protocol of a cluster randomized stepped-wedge trial

Authors: Amado D. Quezada-Sánchez, Evelyn Fuentes-Rivera, Angélica García-Martínez, María del Carmen Hernández-Chávez, Carlos Pineda-Antúnez, Martín Romero Martínez, Armando García-Guerra, Raquel García-Feregrino, Abby Madrigal-Ramírez, Tania Santiago-Angelino, Fabián Olvera-Flores, Lourdes Schnaas, Rafael Pérez-Escamilla, Edson Serván-Mori

Published in: Trials | Issue 1/2022

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Abstract

Background

Early childhood development (ECD) is essential in human capacity building and a critical element in the intergenerational process of human development. In some countries, social programs targeted at improving ECD have proven to be successful. Oaxaca is one of the States with the greatest social inequities in Mexico. Therefore, children in Oaxaca are at a high risk of suboptimal ECD. In 2014, the non-governmental organization (NGO) Un Kilo de Ayuda started to implement the Neurological and Psycho-affective Early Childhood Development Program in eighty marginalized communities of Oaxaca. In this article, we present the impact evaluation design to estimate the effect of this program on ECD.

Methods

We will use a cluster randomized stepped-wedge design with an allocation ratio of 1:1. Communities will be randomly assigned to each study group: four groups of twenty communities each. We expect that children from intervened communities will show better ECD outcomes.

Discussion

This study is one of the few rigorous assessments of the effect of an ECD program on the neurodevelopment of Mexican children recruited in their first 3 years of life from communities of high social vulnerability. Our study design is recommended when the way in which outcomes are measured and assessed depends on age, self-selection is present, and assignment is performed at an aggregate level. Implementation research will be conducted prior to study launch and quality control measures will be in place to maximize the fidelity of study design implementation.

Trial registration

ClinicalTrials.gov NCT04210362
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Metadata
Title
Assessing the effect of an educational intervention on early childhood development among Mexican preschool children in the state of Oaxaca: a study protocol of a cluster randomized stepped-wedge trial
Authors
Amado D. Quezada-Sánchez
Evelyn Fuentes-Rivera
Angélica García-Martínez
María del Carmen Hernández-Chávez
Carlos Pineda-Antúnez
Martín Romero Martínez
Armando García-Guerra
Raquel García-Feregrino
Abby Madrigal-Ramírez
Tania Santiago-Angelino
Fabián Olvera-Flores
Lourdes Schnaas
Rafael Pérez-Escamilla
Edson Serván-Mori
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06024-2

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