Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial

Abstract Background Compared to urban children, children living in rural areas of most countries, including China, are at higher risk of suffering unintentional injuries. Most proven injury prevention interventions, however, are rarely implemented in rural China due to lack of resources. Mobile heal...

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Autores principales:	Jieyi He, Wanhui Wang, Peishan Ning, Peixia Cheng, Jie Li, Ming Zheng, Shujuan Yuan, Lei Yang, Youyou Wu, Huiying Zong, David C. Schwebel, Yang Yang, Guoqing Hu
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Unintentional injury Rural preschooler Cluster randomized controlled trial Application (app) Mobile health Intervention Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/7889454748e8487da1b95a1c83c9ec47
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spelling	oai:doaj.org-article:7889454748e8487da1b95a1c83c9ec472021-11-21T12:10:46ZAssessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial10.1186/s12889-021-12156-y1471-2458https://doaj.org/article/7889454748e8487da1b95a1c83c9ec472021-11-01T00:00:00Zhttps://doi.org/10.1186/s12889-021-12156-yhttps://doaj.org/toc/1471-2458Abstract Background Compared to urban children, children living in rural areas of most countries, including China, are at higher risk of suffering unintentional injuries. Most proven injury prevention interventions, however, are rarely implemented in rural China due to lack of resources. Mobile health interventions are low-cost and easy-to-implement, facilitating implementing injury prevention in resource-limited areas (e.g., rural areas). This study is designed and implemented to examine the effectiveness of an app-based intervention for unintentional injury prevention among rural preschoolers in China. Methods A single-blind, 18-month, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in 2 rural areas of China (Yang County, Shaanxi Province, and Shicheng County, Jiangxi Province). In total, at least 3508 rural caregivers of preschoolers aged 3–6 years old who own a smartphone will be recruited from 24 preschools. Clusters will be randomized at the preschool level and allocated to the control group (receiving routine school-based education plus app-based parenting education excluding unintentional injury prevention) or the intervention group (receiving routine school-based education plus app-based parenting education including unintentional injury prevention). External support strategies will be adopted by local partners to minimize user fatigue, non-compliance, and attrition. Data collection will be conducted at baseline and then every 3 months during the 18-month follow-up time period. Intention-to-treat data analysis will be implemented. Missing values will be imputed by using the Expectation Maximization algorithm. Generalized estimating equation will test the overall effectiveness of the app-based intervention. A per-protocol sensitivity analysis will be conducted to test the robustness of results. Subgroup analyses will follow the strategies for primary analyses. The primary outcome measure is the incidence rate of unintentional injury among preschoolers during the study period. Secondary outcome measures comprise longitudinal changes in caregiver’s attitudes, caregiver-reported supervision behaviors, and caregiver-assessed home environment safety surrounding child unintentional injury prevention in the last week using a standardized audit instrument. Discussion The app-based intervention is expected to be feasible and effective over the 18-month intervention period. If the app is demonstrated effective as hypothesized, we will initiate processes to generalize and popularize it broadly to rural child caregivers across China. Trial registration ChiCTR2000037606 , registered on August 29, 2020.Jieyi HeWanhui WangPeishan NingPeixia ChengJie LiMing ZhengShujuan YuanLei YangYouyou WuHuiying ZongDavid C. SchwebelYang YangGuoqing HuBMCarticleUnintentional injuryRural preschoolerCluster randomized controlled trialApplication (app)Mobile healthInterventionPublic aspects of medicineRA1-1270ENBMC Public Health, Vol 21, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Unintentional injury Rural preschooler Cluster randomized controlled trial Application (app) Mobile health Intervention Public aspects of medicine RA1-1270
spellingShingle	Unintentional injury Rural preschooler Cluster randomized controlled trial Application (app) Mobile health Intervention Public aspects of medicine RA1-1270 Jieyi He Wanhui Wang Peishan Ning Peixia Cheng Jie Li Ming Zheng Shujuan Yuan Lei Yang Youyou Wu Huiying Zong David C. Schwebel Yang Yang Guoqing Hu Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial
description	Abstract Background Compared to urban children, children living in rural areas of most countries, including China, are at higher risk of suffering unintentional injuries. Most proven injury prevention interventions, however, are rarely implemented in rural China due to lack of resources. Mobile health interventions are low-cost and easy-to-implement, facilitating implementing injury prevention in resource-limited areas (e.g., rural areas). This study is designed and implemented to examine the effectiveness of an app-based intervention for unintentional injury prevention among rural preschoolers in China. Methods A single-blind, 18-month, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in 2 rural areas of China (Yang County, Shaanxi Province, and Shicheng County, Jiangxi Province). In total, at least 3508 rural caregivers of preschoolers aged 3–6 years old who own a smartphone will be recruited from 24 preschools. Clusters will be randomized at the preschool level and allocated to the control group (receiving routine school-based education plus app-based parenting education excluding unintentional injury prevention) or the intervention group (receiving routine school-based education plus app-based parenting education including unintentional injury prevention). External support strategies will be adopted by local partners to minimize user fatigue, non-compliance, and attrition. Data collection will be conducted at baseline and then every 3 months during the 18-month follow-up time period. Intention-to-treat data analysis will be implemented. Missing values will be imputed by using the Expectation Maximization algorithm. Generalized estimating equation will test the overall effectiveness of the app-based intervention. A per-protocol sensitivity analysis will be conducted to test the robustness of results. Subgroup analyses will follow the strategies for primary analyses. The primary outcome measure is the incidence rate of unintentional injury among preschoolers during the study period. Secondary outcome measures comprise longitudinal changes in caregiver’s attitudes, caregiver-reported supervision behaviors, and caregiver-assessed home environment safety surrounding child unintentional injury prevention in the last week using a standardized audit instrument. Discussion The app-based intervention is expected to be feasible and effective over the 18-month intervention period. If the app is demonstrated effective as hypothesized, we will initiate processes to generalize and popularize it broadly to rural child caregivers across China. Trial registration ChiCTR2000037606 , registered on August 29, 2020.
format	article
author	Jieyi He Wanhui Wang Peishan Ning Peixia Cheng Jie Li Ming Zheng Shujuan Yuan Lei Yang Youyou Wu Huiying Zong David C. Schwebel Yang Yang Guoqing Hu
author_facet	Jieyi He Wanhui Wang Peishan Ning Peixia Cheng Jie Li Ming Zheng Shujuan Yuan Lei Yang Youyou Wu Huiying Zong David C. Schwebel Yang Yang Guoqing Hu
author_sort	Jieyi He
title	Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial
title_short	Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial
title_full	Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial
title_fullStr	Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial
title_full_unstemmed	Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial
title_sort	assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural chinese preschoolers: protocol for a cluster randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/7889454748e8487da1b95a1c83c9ec47
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Assessing the effectiveness of an app-based child unintentional injury prevention intervention for caregivers of rural Chinese preschoolers: protocol for a cluster randomized controlled trial

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