Abstract
BackgroundCompared 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.MethodsA 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.DiscussionThe 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 registrationChiCTR2000037606, registered on August 29, 2020.
Highlights
Compared to urban children, children living in rural areas of most countries, including China, are at higher risk of suffering unintentional injuries
Various evidence-based child injury prevention interventions have been recommended by agencies such as the World Health Organization (WHO) and the United Nations International Children’s Emergency Fund (UNICEF), such as use of child restraints and seat-belts, child helmets, child-resistant containers, child safety locks, and smoke alarms [3]
This study is the first Mobile health (mHealth) randomized controlled trial (RCT) for caregivers of rural Chinese preschoolers to demonstrate the long-term effectiveness of preventing child unintentional injury via an app-based intervention and we hypothesize the innovative app-based intervention for 18 months will be effective in reducing child unintentional injury risk in rural China
Summary
Study design A single-blind, 18-month follow-up, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in Yang County, Shaanxi Province, and Shicheng County, Jiangxi Province, China. Randomization and blinding Once recruited, each enrolled preschool will be randomly allocated to a group according to the order of computer-generated random number sequence by an Interventions Both the intervention and control groups will receive routine school-based education from each included preschool plus the app-based education programs. Besides sufficient external support from the coordinating groups, several other strategies will be flexibly implemented to encourage active use of the app and participation in the study In both intervention and control groups, a small amount of app-based reward points will be granted based on the participant’s engagement. This study will strictly adhere to the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement [37] and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement [38] to analyze the data and report the results
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