Prevention of Illicit Drug Use Through a School-Based Program: Results of a Longitudinal, Cluster-Randomized Controlled Trial

BACKGROUND InCharge is a newly developed school-based health intervention aimed at older adolescents. It aims to promote a healthier lifestyle by increasing self-regulation skills. After the InCharge program’s effectiveness was previously investigated in a pilot study, the content of the program was adapted. OBJECTIVE This study describes the protocol of a cluster randomized controlled trial that aims to investigate the effectiveness of the InCharge program. METHODS A cluster randomized controlled trial including 70 classes with older adolescents (aged 16 years or older) in the Netherlands will be conducted to test the effectiveness of the InCharge program. After schools are recruited, randomization occurs at the class level. The trial consists of the following two conditions: an experimental condition and a control condition. Participants in the experimental condition will be given the InCharge intervention, consisting of four lessons of 50 minutes, with each lesson containing three assignments of approximately 15 minutes. While participants in the experimental condition will receive InCharge, participants in the control condition will receive regular academic school courses. Surveys are administered 1 week before the intervention (baseline), 1 week after the intervention (posttest), and 12 weeks after the intervention (follow-up). Variables of interest include, but are not limited to, self-regulation; predictors of snack intake, physical activity, and alcohol use; and interpersonal communication regarding these health behaviors. In addition to surveys, observations will be conducted during the first and fourth lessons, teachers will be interviewed, and focus groups will be held with a selection of students from the intervention condition. RESULTS Enrollment started in September 2017. As of June 2019, a total of 1216 participants were enrolled for this trial. Findings will be published in peer-reviewed journals and presented at conferences. The trial has been approved by the Ethics Review Board of the Faculty of Social and Behavioral Sciences of the University of Amsterdam (reference no.: 2017-PC-8244). CONCLUSIONS In this study protocol, the design of a cluster randomized controlled trial is described, which assesses how effectively the school-based intervention InCharge stimulates healthier lifestyles in late adolescents. We hypothesize that participants in the experimental condition will consume less alcohol, eat fewer unhealthy snacks, and be more physically active compared with participants in the control condition. CLINICALTRIAL Netherlands Trial Register (NL6654); https://www.trialregister.nl/trial/6654 INTERNATIONAL REGISTERED REPORT RR1-10.2196/17702

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Assessing the Effectiveness of an App-Based Unintentional Injury Intervention for Caregivers of Rural Chinese Preschoolers: Protocol for a Cluster Randomized Controlled Trial

10.21203/rs.3.rs-962673/v1 ◽

2021 ◽

Author(s):

Jieyi He ◽

Wanhui Wang ◽

Peishan Ning ◽

Peixia Cheng ◽

Jie Li ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Injury Prevention ◽

Rural Areas ◽

Controlled Trial ◽

Unintentional Injury ◽

Cluster Randomized Controlled Trial ◽

Parenting Education ◽

Randomized Controlled ◽

School Based ◽

Cluster Randomized

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 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 (ITT) data analysis will be implemented. Missing values will be imputed by using the Expectation Maximization algorithm (EM). Generalized estimation equations (GEE) will test the overall effectiveness of the app-based intervention. A per-protocol (PP) sensitivity analysis will be conducted to test the robustness of results. Subgroup analyses will follow the strategies for primary analyses.ResultsThe 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.ConclusionThe 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.

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