NDLI: Evaluating the effectiveness of the safety experience room, an affordable interactive education intervention to prevent unintentional injury among rural preschoolers in China: protocol for a cluster randomized controlled trial

Content Provider	Springer Nature : BioMed Central
Author	He, Jieyi Wang, Wanhui Ning, Peishan Schwebel, David C. Yang, Yang Cheng, Peixia Li, Jie Zhao, Min Li, Weiqiang Zhang, Na Liu, Han Hu, Guoqing
Abstract	Background Interactive and experiential learning programs have proven effective to teach children safety and prevent child unintentional injury. However, previously-published programs were designed primarily to address safety concerns of children living in urban, well-resourced areas, and therefore might be less effective or economically infeasible to distribute to children in resource-limited areas, such as those living in rural areas or underdeveloped regions. This proposed study will evaluate the effectiveness of teaching children safety lessons to rural preschoolers in China through the preschool-based Safety Experience Room intervention that was developed based on relevant theories, the lessons of previous intervention research, the characteristics of child injuries in underdeveloped rural areas, and the needs and circumstances of rural families and preschools in China. The study will also evaluate the cost-effectiveness of delivering the program. Methods and analysis A single-blinded, 12-month follow-up, parallel-group cluster randomized controlled trial with a 1:1 allocation ratio will be implemented in two selected counties. In total, at least 2378 rural preschoolers aged 3–6 years old will be recruited from 12 preschools, 6 in Yang County and 6 in Shicheng County. Clusters will be randomized at the preschool level and allocated to the control group (routine school-based education) or the intervention group (routine school-based education plus the Safety Experience Room education). External support strategies will be implemented by local partners to minimize attrition. Data collection will be conducted at baseline and then every 3 months during a 12-month follow-up time period. Intention-to-treat (ITT) data analysis will be used. Generalized estimation equations (GEE) will evaluate the effectiveness of the program and generalized cost-effectiveness analysis (GCEA) will evaluate the cost-effectiveness of it. A per-protocol (PP) sensitivity analysis will assess the robustness of ITT results. Subgroup analyses will be performed to evaluate the impact of socio-demographic factors on the intervention effect, following the same strategies as the primary analyses. Discussion The newly-designed Safety Experience Room program is expected to be feasible, effective, and financially beneficial. If these hypotheses prove true, we will take steps to disseminate the program to rural preschools across China. Trial registration Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), CHiCTR2000038025, registered on 8 September 2020.
Related Links	https://bmcpublichealth.biomedcentral.com/counter/pdf/10.1186/s12889-023-15432-1.pdf
Ending Page	12
Page Count	12
Starting Page	1
File Format	HTM / HTML
ISSN	14712458
DOI	10.1186/s12889-023-15432-1
Journal	BMC Public Health
Issue Number	1
Volume Number	23
Language	English
Publisher	BioMed Central
Publisher Date	2023-03-20
Access Restriction	Open
Subject Keyword	Public Health Medicine Epidemiology Biostatistics Vaccine Environmental Health Unintentional injury Preschooler Rural area China Interactive safety education Cluster randomized controlled trial Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health
Journal Impact Factor	3.5/2023
5-Year Journal Impact Factor	3.9/2023

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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