Testing the efficacy of Stay Awake, Stay Alive©: a Multi-Theory Model (MTM)-based intervention protocol for reducing drowsy driving behavior among college students Abstract Background: Drowsy driving is a critical public health concern, particularly among college students who face a unique convergence of lifestyle risk factors, including academic pressures, irregular sleep schedules, and reliance on caffeine as a substitute for adequate rest. Nearly 50% of college students report having driven while drowsy within the past month, yet targeted, theory-driven interventions for this population remain scarce. Objective: This study outlines the protocol for a randomized controlled trial (RCT) evaluating the efficacy of Stay Awake, Stay Alive (Preprint)

<sec> <title>BACKGROUND</title> <p>Drowsy driving is a critical public health concern, particularly among college students who face a unique convergence of lifestyle risk factors, including academic pressures, irregular sleep schedules, and reliance on caffeine as a substitute for adequate rest. Nearly 50% of college students report having driven while drowsy within the past month, yet targeted, theory-driven interventions for this population remain scarce.</p> </sec> <sec> <title>OBJECTIVE</title> <p>This study outlines the protocol for a randomized controlled trial (RCT) evaluating the efficacy of Stay Awake, Stay Alive©, a Multi-Theory Model (MTM)-based educational intervention designed to reduce drowsy driving behavior among college students compared to a standard American Automobile Association (AAA) knowledge-based program.</p> </sec> <sec> <title>METHODS</title> <p>This study employs a single-blinded educational RCT design, registered on ClinicalTrials.gov (NCT07434921) and approved by the University of Nevada, Las Vegas Institutional Review Board (UNLV-2025-627). A total of 72 college students will be recruited and randomly assigned to either the experimental group (Stay Awake, Stay Alive©) or the comparison group (AAA program), with 36 participants per group. The MTM-based intervention integrates all six theoretical constructs, including participatory dialogue, behavioral confidence, changes in the physical environment, emotional transformation, practice for change, and changes in the social environment. It is delivered across four weekly in-person sessions of 75 minutes each. Participants will complete a validated 43-item questionnaire assessing drowsy driving behavior and MTM construct scores at three time points: baseline, immediate post-intervention at four weeks, and a two-week follow-up. Data will be analyzed using two-factor repeated measures ANOVA and ANCOVA (if needed) in SPSS Version 29 and SAS 9.4, with a significance level of P&lt;.05.</p> </sec> <sec> <title>RESULTS</title> <p>Recruitment commenced in April 2026, and 17 participants have been enrolled to date. Data collection is anticipated to be completed by October 2026.</p> </sec> <sec> <title>CONCLUSIONS</title> <p>This protocol can establish a replicable and scalable evidence-based framework for reducing drowsy driving among college students and contribute meaningfully to the literature on theory-driven behavioral interventions for road safety.</p> </sec> <sec> <title>CLINICALTRIAL</title> <p>ClinicalTrials.gov NCT07434921</p> </sec>