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Набор по приглашению NCT07434921

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

Без фазы С лечением Drowsiness Sleep Deprivation Fatigue

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MTM Theory based intervention, Standard AAA Knowledge based.
Кому может быть актуально
Состояния в реестре: Drowsiness, Sleep Deprivation, Fatigue. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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 1. Is there a statistically and practically significant difference in the mean score of drowsy driving behavior in the experimental group (Multi-Theory Model (MTM)-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA (American Automobile Association)program-based intervention) from pre-intervention to post-intervention to two-week follow-up 2. Is there a statistically and practically significant difference in the mean score (pre-intervention to post-intervention to two-week follow-up) for the intent to initiate reducing drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison (standard AAA program-based intervention) groups? 3. Is there a statistically and practically significant difference in the mean score (pre-intervention to post-intervention to two-week follow-up) for the intent to sustain the reduction of drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison (standard AAA program-based intervention) groups? Researchers will compare two groups to see which approach leads to greater improvement: Group 1: MTM-based "Stay Awake, Stay Alive" program (interactive weekly sessions designed using behavior change theory). Group 2: Standard drowsy driving education program, AAA (American Automobile Association) based education. By comparing these groups, researchers can see whether the MTM-based program provides added benefit beyond standard education alone. Both groups receive the same overall time and attention, so differences in results can be linked more clearly to the program's strategies rather than to simply receiving education. Participants will: * 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.

Подробное описание

Drowsy driving among college students Drowsy driving among college students represents a significant public health and roadway safety concern due to the convergence of developmental, academic, and lifestyle-related risk factors. Emerging adulthood is characterized by irregular sleep-wake patterns, heightened academic demands, and social behaviors that may compromise sleep duration and quality. In a 2023 cross-sectional survey administered via Qualtrics (n = 725), 49.4% of respondents reported engaging in drowsy driving within the past month, underscoring the prevalence of this behavior in this population.

Insufficient sleep has been shown to increase crash risk by impairing critical cognitive and psychomotor functions, including sustained attention, processing speed, decision-making, and reaction time, all of which are essential for safe vehicle operation. Additionally, reliance on caffeine and energy drinks to counteract fatigue may produce a transient perception of alertness without fully restoring cognitive performance, potentially contributing to risk compensation and continued unsafe driving behavior.

Statement of the Problem Drowsy driving, defined as operating a motor vehicle while experiencing substantial sleepiness or fatigue, represents a significant public health and traffic safety concern, particularly among college-aged populations. Fatigue impairs neurocognitive and psychomotor functioning, including sustained attention, executive decision-making, vigilance, reaction time, and information processing speed, thereby increasing the likelihood of motor vehicle collisions. Although often underrecognized, drowsy driving is estimated to contribute to approximately 10%-20% of motor vehicle crashes in the United States, underscoring its substantial contribution to preventable injuries and fatalities.

College students constitute a high-risk group due to the convergence of academic demands, late-night study habits, part-time employment, irregular sleep-wake cycles, and socially driven sleep restriction. Emerging adulthood is also characterized by circadian phase delay, which may further reduce sleep duration and quality. Many students rely on caffeine and energy drinks to counteract fatigue. While these stimulants may temporarily enhance perceived alertness, they can disrupt sleep patterns and contribute to persistent daytime sleepiness, thereby sustaining risk. Nearly half of college students report engaging in drowsy driving, highlighting the widespread nature of this behavior.

A major challenge is the gradual onset of sleep-related impairment. Early warning signs such as frequent yawning, difficulty keeping eyes open, reduced situational awareness, and unintended lane drifting are often subtle and dismissed. The use of sedating medications and alcohol further exacerbates impairment. These factors emphasize the need for targeted, theory-driven, evidence-based interventions to promote sleep health and reduce drowsy driving among college students.

Research Questions and Statistical Hypotheses

1. Is there a statistically and practically significant difference in the mean score of drowsy driving behavior in the experimental group (MTM theory-based intervention, Stay Awake, Stay Alive©) and comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up?

Null Hypothesis (H1₀):

There is no statistically significant difference in the mean score of drowsy driving behavior days between the experimental group and the comparison group from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H1₁):

There is a statistically significant difference in the mean score of drowsy driving behavior days between the experimental group and the comparison group from pre-intervention to post-intervention to two-week follow-up. 2. Is there a statistically and practically significant difference in the mean score of participatory dialogue between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up?

Null Hypothesis (H2₀):

There is no statistically or practically significant difference in the mean score of participatory dialogue between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H2₁):

There is a statistically and practically significant difference in the mean score of participatory dialogue between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up. 3. Is there a statistically and practically significant difference in the mean score of behavioral confidence between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up?

Null Hypothesis (H₀):

There is no statistically or practically significant difference in the mean score of behavioral confidence between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H3₁):

There is a statistically and practically significant difference in the mean score of behavioral confidence between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up. 4. Is there a statistically and practically significant difference in the mean score of changes in the physical environment between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up?

Null Hypothesis (H4₀):

There is no statistically or practically significant difference in the mean score of changes in the physical environment between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H4₁):

There is a statistically and practically significant difference in the mean score of changes in the physical environment between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up. 5. Is there a statistically and practically significant difference in the mean score of change in the emotional transformation between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up?

Null Hypothesis (H5₀):

There is no statistically or practically significant difference in the mean score of emotional transformation between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H5₁):

There is a statistically and practically significant difference in the mean score of emotional transformation between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up. 6. Is there a statistically and practically significant difference in the mean score of change in the practice for change between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up?

Null Hypothesis (H6₀):

There is no statistically or practically significant difference in the mean score of change in the practice for change between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H6₁):

There is a statistically and practically significant difference in the mean change in the practice for change scores between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up. 7. Is there a statistically and practically significant difference in the mean scores of changes in the social environment between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up?

Null Hypothesis (H7₀):

There is no statistically or practically significant difference in the mean scores of changes in the social environment between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H7₁):

There is a statistically and practically significant difference in the mean scores of changes in the social environment between the experimental group (MTM-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up. 8. Is there a statistically and practically significant difference in the mean score (pre-intervention to post-intervention to two-week follow-up) for the intent to initiate reducing drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison (standard AAA program-based intervention) groups?

Null Hypothesis (H8₀):

There is no statistically significant difference in the mean scores for intent to initiate reducing drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison groups (standard AAA program-based intervention) from pre-intervention to post-intervention to two-week follow-up.

Alternative Hypothesis (H8₁):

There is a statistically significant difference in the mean scores for intent to initiate reducing drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison groups (standard AAA program-based intervention) across pre-intervention to post-intervention to two-week follow-up. 9. Is there a statistically and practically significant difference in the mean score (pre-intervention to post-intervention to two-week follow-up) for the intent to sustain the reduction of drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison (standard AAA program-based intervention) groups?

Null Hypothesis (H9₀):

Вмешательства

  • Поведенческое MTM Theory based intervention
    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 fati
  • Поведенческое Standard AAA Knowledge based
    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.

Первичные конечные точки

  • Change From Baseline in Number of Days of Self-Reported Drowsy Driving in the Past 14 Days [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (Week 0), immediately post-intervention (Week 4), and follow-up (Week 6)]

Критерии участия

Критерии включения

  • College student enrolled at a university in Nevada
  • Age ≥ 18 years
  • Currently enrolled in an undergraduate or graduate program
  • Able to provide informed consent
  • Meets the "eligibility screener" items related to prior drowsy driving Exclusion criteria
  • Fails the initial drowsy-driving eligibility screener
  • Medical/sleep disorders (e.g., obstructive sleep apnea) are deliberately excluded

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Nevada Las Vegas — Las Vegas

Публикации

  • Westley JA, Peterson J, Cook B. Drowsy Driving Among Nurses: Potential Impetus to Support Napping. Workplace Health Saf. 2022 Dec;70(12):551-555. doi: 10.1177/21650799221111300. Epub 2022 Aug 1. PMID 35915894
  • 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. PMID 31739851
  • 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
  • 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
  • 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. PMID 35652816
  • 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
  • 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
  • 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, T PMID 40228833

Идентификаторы

NCT: NCT07434921 · UNLV-2025-627

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗