TESTING AN MTM THEORY-BASED INTERVENTION ON REDUCING DROWSY DRIVING BEHAVIOR, "STAY AWAKE, STAY ALIVE ©," AMONG COLLEGE STUDENTS

NCT07434921 | Enrolling By Invitation DMC

• 1 other identifier: UNLV-2025-627
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled educational study is to learn whether a structured, theory-based program can help reduce drowsy driving among college students (18 years and older) in Nevada. Drowsy driving means driving when you are very sleepy, tired, or struggling to stay alert. It is a serious safety problem because it can slow reaction time, reduce attention, and increase the risk of crashes, injuries, and even deaths. Many college students have irregular sleep schedules due to classes, jobs, late-night studying, and social activities, which can increase tiredness and increase the likelihood of drowsy driving. Research question

• Complete a short screening to confirm eligibility (for example, being 18+ and having recent experiences of drowsy driving)
• Provide informed consent before any study activities begin
• Be randomly assigned to one of the two programs
• Attend four weekly sessions (about 75 minutes each) over 4 weeks, with a short break and refreshments during sessions
• Complete surveys at three time points: Baseline (before the program begins), Post-intervention (after week 4), and Follow-up (after two weeks)
• Answer questions about their drowsy driving behavior and related influences, such as fatigue triggers, barriers to sleep, confidence to avoid driving when sleepy, and supports that make safe choices easier. The study will measure changes in drowsy driving behavior and in MTM-related factors that may explain why these changes occur. For example, the MTM-based program helps students think about the benefits of avoiding drowsy driving (and the risks of continuing it), build behavioral confidence to choose safer options, and identify practical environmental supports (such as a safe place to rest, asking a friend for a ride, using ride-share or public transportation, or adjusting trip timing). It also supports emotional transformation (turning concern into motivation), practice for change (setting goals and tracking progress), and building a supportive social environment (friends and family encouraging safer choices). During the sessions, participants may learn and practice real-world skills such as recognizing early warning signs of sleepiness (heavy eyelids, frequent yawning, drifting lanes, missing exits), using short rest breaks and safe "pull-over" plans, managing schedules to reduce late-night driving, and creating a personal action plan for high-risk situations (after work shifts, long study nights, or long-distance travel). The follow-up survey helps researchers see whether any improvements continue beyond the end of the 4-week program. At the end of the study, results will help colleges, public health professionals, and road safety programs understand what types of education are most effective for preventing drowsy driving in young adults. If the MTM-based program is effective, it could be adapted and used more widely to improve student safety and reduce injuries related to drowsy driving. Participants who complete the final follow-up survey will receive an incentive.

Conditions

Drowsiness; Sleep Deprivation; Fatigue

Keywords

College Students; Multi theory model; Drowsy driving; fatigue-related accidents; Road Safety

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Number of Days of Self-Reported Drowsy Driving in the Past 14 Days

  Self-reported number of days (0-14) during which participants drove while feeling drowsy or fatigued in the previous 14 days. Participants will report the frequency of drowsy driving episodes using a structured survey item assessing behavior over a two-week recall period.

  Baseline (Week 0), immediately post-intervention (Week 4), and follow-up (Week 6)

• Change From Baseline in Intent to Initiate Reduction of Drowsy Driving (MTM Initiation Scale Score)

  The intent to initiate stopping drowsy driving measured using a single Likert-type item assessing the likelihood of initiating attempts to stop drowsy driving in the coming week. Response options range from 0 (Not at all likely) to 4 (Completely likely); the total score range 0 to 4.

  Baseline (Week 0), immediately post-intervention (Week 4), and follow-up (Week 6)

• Change From Baseline in Intent to Sustain Reduction of Drowsy Driving (MTM Sustenance Scale Score)

  The Intent to sustain stopping drowsy driving measured using a single Likert-type item assessing the likelihood of stopping drowsy driving from now on. Response options range from 0 (Not at all likely) to 4 (Completely likely); the total score range is 0 to 4.

  Baseline (Week 0), immediately post-intervention (Week 4), and follow-up (Week 6)

Study Arms (2)

MTM-based intervention

EXPERIMENTAL

In this arm, participants will attend a 4-week educational intervention delivered in weekly group sessions (approximately 75 minutes each, including a 5-minute break). The sessions will incorporate experiential learning strategies such as role-plays, video dramatizations, reflective journaling, and peer discussions. Participants will use a provided sleep journal to record nightly sleep duration and any drowsy driving episodes. They will also note emotional or situational triggers related to fatigue and discuss key reflections during weekly group discussions. Session content will address the key constructs of the Multi-Theory Model (MTM) to support behavior change.

Behavioral: MTM Theory based intervention

Standard AAA Knowledge based

ACTIVE COMPARATOR

Participants in the AAA (American Automobile Association) intervention (comparison) group will complete a 5-hour online course focused on drowsy driving prevention. The course will be delivered in four sessions, each approximately 75 minutes in length, matching the session duration of the experimental arm. All sessions will be completed under the supervision of the investigator and CITI-trained study personnel.

Behavioral: Standard AAA Knowledge based

Interventions

MTM Theory based intervention BEHAVIORAL

In this arm, participants will attend a 4-week educational intervention delivered in weekly group sessions (approximately 75 minutes each, including a 5-minute break). The sessions will incorporate experiential learning strategies such as role-plays, video dramatizations, reflective journaling, and peer discussions. Participants will use a provided sleep journal to record nightly sleep duration and any drowsy driving episodes. They will also note emotional or situational triggers related to fatigue and discuss key reflections during weekly group discussions. Session content will address the key constructs of the Multi-Theory Model (MTM) to support behavior change.

MTM-based intervention

Standard AAA Knowledge based BEHAVIORAL

Participants in the AAA (American Automobile Association) intervention (comparison) group will complete a 5-hour online course focused on drowsy driving prevention. The course will be delivered in four sessions, each approximately 75 minutes in length, matching the session duration of the experimental arm. All sessions will be completed under the supervision of the investigator and CITI-trained study personnel.

Standard AAA Knowledge based

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: In this study, we welcome all genders.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• College student enrolled at a university in Nevada
• Age ≥ 18 years
• Currently enrolled in an undergraduate or graduate program
• Able to provide informed consent

You may not qualify if:

• Fails the initial drowsy-driving eligibility screener
• Medical/sleep disorders (e.g., obstructive sleep apnea) are deliberately excluded

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Related Publications (16)

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  PMID: 35915894 BACKGROUND

• Walia HK, Thompson NR, Pascoe M, Faisal M, Moul DE, Katzan I, Mehra R, Foldvary-Schaefer N. Effect of Positive Airway Pressure Therapy on Drowsy Driving in a Large Clinic-Based Obstructive Sleep Apnea Cohort. J Clin Sleep Med. 2019 Nov 15;15(11):1613-1620. doi: 10.5664/jcsm.8024.

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• Taylor DJ, Bramoweth AD. Patterns and consequences of inadequate sleep in college students: substance use and motor vehicle accidents. J Adolesc Health. 2010 Jun;46(6):610-2. doi: 10.1016/j.jadohealth.2009.12.010. Epub 2010 Feb 25.

  PMID: 20472221 BACKGROUND

• Sharma M, Batra K, Davis RE, Wilkerson AH. Explaining Handwashing Behavior in a Sample of College Students during COVID-19 Pandemic Using the Multi-Theory Model (MTM) of Health Behavior Change: A Single Institutional Cross-Sectional Survey. Healthcare (Basel). 2021 Jan 6;9(1):55. doi: 10.3390/healthcare9010055.

  PMID: 33419211 BACKGROUND

• Meltzer LJ, Plog AE, Swenka D, Reeves D, Wahlstrom KL. Drowsy driving and teen motor vehicle crashes: Impact of changing school start times. J Adolesc. 2022 Jul;94(5):800-805. doi: 10.1002/jad.12053. Epub 2022 Jun 2.

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• Lohsoonthorn V, Khidir H, Casillas G, Lertmaharit S, Tadesse MG, Pensuksan WC, Rattananupong T, Gelaye B, Williams MA. Sleep quality and sleep patterns in relation to consumption of energy drinks, caffeinated beverages, and other stimulants among Thai college students. Sleep Breath. 2013 Sep;17(3):1017-28. doi: 10.1007/s11325-012-0792-1. Epub 2012 Dec 14.

  PMID: 23239460 BACKGROUND

• Kapukotuwa S, Bonsu L, Chatterjee A, Fudolig M, Sharma M. Examining the Gambling Behavior of University Students: A Cross-Sectional Survey Applying the Multi-Theory Model (MTM) of Health Behavior Change in a Single Institution. Healthcare (Basel). 2023 Jul 28;11(15):2151. doi: 10.3390/healthcare11152151.

  PMID: 37570391 BACKGROUND

• Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.

  PMID: 40228833 BACKGROUND

• Higgins JS, Michael J, Austin R, Akerstedt T, Van Dongen HP, Watson N, Czeisler C, Pack AI, Rosekind MR. Asleep at the Wheel-The Road to Addressing Drowsy Driving. Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsx001.

  PMID: 28364516 BACKGROUND

• Goncalves M, Amici R, Lucas R, Akerstedt T, Cirignotta F, Horne J, Leger D, McNicholas WT, Partinen M, Teran-Santos J, Peigneux P, Grote L; National Representatives as Study Collaborators. Sleepiness at the wheel across Europe: a survey of 19 countries. J Sleep Res. 2015 Jun;24(3):242-53. doi: 10.1111/jsr.12267.

  PMID: 25581328 BACKGROUND

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  PMID: 17695343 BACKGROUND

• Cori JM, Wilkinson VE, Soleimanloo SS, Westlake J, Stevens B, Rajaratnam SMW, Howard ME. A brief assessment of eye blink drowsiness immediately prior to or following driving detects drowsiness related driving impairment. J Sleep Res. 2023 Jun;32(3):e13785. doi: 10.1111/jsr.13785. Epub 2022 Dec 7.

  PMID: 36478313 BACKGROUND

• Cai AWT, Manousakis JE, Singh B, Kuo J, Jeppe KJ, Francis-Pester E, Shiferaw B, Beatty CJ, Rajaratnam SMW, Lenne MG, Howard ME, Anderson C. On-road driving impairment following sleep deprivation differs according to age. Sci Rep. 2021 Nov 3;11(1):21561. doi: 10.1038/s41598-021-99133-y.

  PMID: 34732793 BACKGROUND

• Ayas S, Donmez B, Tang X. Drowsiness Mitigation Through Driver State Monitoring Systems: A Scoping Review. Hum Factors. 2024 Sep;66(9):2218-2243. doi: 10.1177/00187208231208523. Epub 2023 Nov 20.

  PMID: 37982386 BACKGROUND

• American Academy of Sleep Medicine. (2024). Sleepy driving highly prevalent among college students. https://aasm.org/sleepy-driving-highly-prevalent-among-college-students/

  BACKGROUND

• Akhter MS, Kapukotuwa S, Dai CL, Awan A, Odejimi OA, Sharma M. Theory-Based Determinants of Stopping Drowsy Driving Behavior in College Students: A Cross-Sectional Study. Int J Environ Res Public Health. 2024 Aug 30;21(9):1157. doi: 10.3390/ijerph21091157.

  PMID: 39338040 RESULT

Related Links

• Theory-Based Determinants of Stopping Drowsy Driving Behavior in College Students: A Cross-Sectional Study

MeSH Terms

Conditions

Sleepiness; Sleep Deprivation; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Study Officials

• MANOJ SHARMA

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 27, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)