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
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Publicado: BMC 2021
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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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