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TESTEN VAN EEN OP MTM-THEORIE GEBASEERDE INTERVENTIE OP HET VERMINDEREN VAN SLAPERIG RIJDGEDRAG, "STAY AWAKE, STAY ALIVE ©," ONDER STUDENTEN

21 mei 2026 bijgewerkt door: Manoj Sharma, University of Nevada, Las Vegas

TESTEN VAN EEN OP DE MTM-THEORIE GEBASEERDE INTERVENTIE OM SLAPERIG RIJDGEDRAG TE VERMINDEREN, "BLIJF WAKKER, BLIJF IN LEVEN, ©" ONDER STUDENTEN: EEN EDUCATIEVE GERANDOMISEERDE CONTROLEPROEF

Het doel van deze gerandomiseerde gecontroleerde educatieve studie is om te onderzoeken of een gestructureerd, theoriegebaseerd programma kan helpen om vermoeid rijden onder studenten (18 jaar en ouder) in Nevada te verminderen. Vermoeid rijden betekent rijden wanneer u erg slaperig, moe bent of moeite heeft om alert te blijven. Het is een ernstig veiligheidsprobleem omdat het de reactietijd kan vertragen, de aandacht kan verminderen en het risico op ongevallen, letsel en zelfs overlijden kan vergroten. Veel studenten hebben onregelmatige slaapschema's vanwege colleges, banen, nachtelijk studeren en sociale activiteiten, wat vermoeidheid kan vergroten en de kans op vermoeid rijden kan verhogen.

Onderzoeksvraag

  1. Is er een statistisch en praktisch significant verschil in de gemiddelde score van vermoeid rijgedrag in de experimentele groep (Multi-Theory Model (MTM)-gebaseerde interventie, Stay Awake, Stay Alive©) en de vergelijkingsgroep (standaard AAA (American Automobile Association)-programmagebaseerde interventie) van pre-interventie tot post-interventie tot follow-up na twee weken?
  2. Is er een statistisch en praktisch significant verschil in de gemiddelde score (pre-interventie tot post-interventie tot follow-up na twee weken) voor de intentie om vermoeid rijden te verminderen tussen de experimentele (MTM-gebaseerde interventie, Stay Awake, Stay Alive©) en vergelijkingsgroep (standaard AAA-programmagebaseerde interventie)?
  3. Is er een statistisch en praktisch significant verschil in de gemiddelde score (pre-interventie tot post-interventie tot follow-up na twee weken) voor de intentie om de vermindering van vermoeid rijden vol te houden tussen de experimentele (MTM-gebaseerde interventie, Stay Awake, Stay Alive©) en vergelijkingsgroep (standaard AAA-programmagebaseerde interventie)?

Onderzoekers zullen twee groepen vergelijken om te zien welke aanpak tot een grotere verbetering leidt:

Groep 1: MTM-gebaseerd "Stay Awake, Stay Alive"-programma (interactieve wekelijkse sessies ontworpen met gedragsveranderingstheorie).

Groep 2: Standaard educatieprogramma voor vermoeid rijden, AAA (American Automobile Association)-gebaseerde educatie.

Door deze groepen te vergelijken, kunnen onderzoekers zien of het MTM-gebaseerde programma een toegevoegde waarde biedt bovenop standaard educatie alleen. Beide groepen ontvangen dezelfde totale tijd en aandacht, zodat verschillen in resultaten duidelijker gekoppeld kunnen worden aan de strategieën van het programma in plaats van alleen aan het ontvangen van educatie.

Deelnemers zullen:

  • Een korte screening voltooien om geschiktheid te bevestigen (bijvoorbeeld 18+ zijn en recente ervaringen met vermoeid rijden hebben)
  • Geïnformeerde toestemming verlenen voordat enige studieactiviteiten beginnen
  • Willekeurig worden toegewezen aan een van de twee programma's
  • Vier wekelijkse sessies bijwonen (ongeveer 75 minuten elk) over 4 weken, met een korte pauze en verfrissingen tijdens de sessies
  • Enquêtes invullen op drie tijdstippen: Baseline (voordat het programma begint), Post-interventie (na week 4), en Follow-up (na twee weken)
  • Vragen beantwoorden over hun vermoeid rijgedrag en gerelateerde invloeden, zoals vermoeidheidstriggers, barrières voor slaap, vertrouwen om niet te rijden wanneer slaperig, en ondersteuning die veilige keuzes gemakkelijker maakt.

De studie zal veranderingen meten in vermoeid rijgedrag en in MTM-gerelateerde factoren die kunnen verklaren waarom deze veranderingen optreden. Het MTM-gebaseerde programma helpt studenten bijvoorbeeld na te denken over de voordelen van het vermijden van vermoeid rijden (en de risico's van het voortzetten ervan), gedragsvertrouwen op te bouwen om veiligere opties te kiezen, en praktische omgevingsondersteuning te identificeren (zoals een veilige plek om te rusten, een vriend vragen om een rit, gebruik van ride-share of openbaar vervoer, of het aanpassen van reistijden). Het ondersteunt ook emotionele transformatie (zorgen omzetten in motivatie), oefenen voor verandering (doelen stellen en voortgang bijhouden), en het opbouwen van een ondersteunende sociale omgeving (vrienden en familie die veiligere keuzes aanmoedigen).

Tijdens de sessies kunnen deelnemers realistische vaardigheden leren en oefenen, zoals het herkennen van vroege waarschuwingssignalen van slaperigheid (zware oogleden, vaak gapen, van rijstrook afdwalen, afslagen missen), korte rustpauzes en veilige "stop"-plannen gebruiken, schema's beheren om nachtelijk rijden te verminderen, en een persoonlijk actieplan maken voor risicovolle situaties (na diensten, lange studienachten of langeafstandsreizen). De follow-up enquête helpt onderzoekers te zien of verbeteringen blijven bestaan na het einde van het 4-weken durende programma.

Aan het einde van de studie zullen de resultaten hogescholen, volksgezondheidsprofessionals en verkeersveiligheidsprogramma's helpen begrijpen welke soorten educatie het meest effectief zijn voor het voorkomen van vermoeid rijden bij jongvolwassenen. Als het MTM-gebaseerde programma effectief is, kan het worden aangepast en breder worden gebruikt om de veiligheid van studenten te verbeteren en letsel gerelateerd aan vermoeid rijden te verminderen. Deelnemers die de laatste follow-up enquête voltooien, ontvangen een incentive.

Studie Overzicht

Gedetailleerde beschrijving

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):

There is no statistically significant difference in the mean scores for intent to sustain reduction of 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.

Alternative Hypothesis (H9₁):

There is a statistically significant difference in the mean scores for intent to sustain reduction of 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.

Theoretical Framework The Multi-Theory Model (MTM) is a contemporary health behavior change theory that explains both initiation and sustenance of behavior change. It blends cognitive, conative, and environmental elements from established theories and is intended to be parsimonious, culturally adaptable, and applicable across individual, group, and community contexts. MTM has shown usefulness in college populations for behaviors such as handwashing, telehealth adoption, and gambling behavior change. In this study, MTM guides the development and evaluation of an intervention to reduce drowsy driving. MTM includes six constructs across two phases. Initiation involves participatory dialogue about pros and cons, behavioral confidence to avoid drowsy driving, and changes in the physical environment that support safer choices. Sustenance involves emotional transformation, practice for change through self-regulation, and changes in the social environment via supportive peers and accountability, safely over time.

Innovation of the Study The present study introduces innovation by employing the Multi-Theory Model (MTM) of health behavior change, a modern fourth-generation framework, to examine the antecedents of drowsy driving among college students. A key strength of MTM is its clear differentiation between two phases of behavior change: initiation and sustenance. The initiation phase includes three constructs: (a) participatory dialogue, conceptualized as the perceived balance between advantages and disadvantages of behavior change; (b) behavioral confidence, defined as an individual's perceived certainty in their ability to initiate change; and (c) changes in the physical environment, reflecting access to resources and environmental supports that facilitate behavior modification. The sustenance phase similarly includes three constructs: (a) emotional transformation, which involves directing emotions toward goal commitment and self-motivation; (b) practice for change, describing ongoing self-regulation strategies to overcome barriers and remain focused; and (c) changes in the social environment, emphasizing the role of supportive interpersonal relationships in maintaining behavior over time.

To the best of my knowledge, this is the first study to apply MTM to understand drowsy driving behaviors among college students. By using MTM, the study contributes a novel theoretical lens to a critical public health problem and generates practical insights into both the initiation and long-term maintenance of safer driving behavior. This approach strengthens the scientific foundation for developing targeted, theory-driven interventions that can reduce drowsy driving in college populations.

Significance of the Study Reducing drowsy driving among college students is highly significant because this population is especially vulnerable to fatigue due to academic stress, inconsistent schedules, and lifestyle-related sleep disruption. Drowsy driving is a major safety concern, as fatigue impairs reaction time, judgment, and sustained attention skills essential for safe driving. Younger drivers may also underestimate their level of impairment, further increasing crash risk. Evidence suggests that the effects of sleep deprivation can resemble alcohol-related impairment, heightening the likelihood of collisions among young adults. Notably, nearly half of college students surveyed reported engaging in drowsy driving within the past month, demonstrating the magnitude of this issue in this population.

Beyond immediate risk, drowsy driving carries broader public health consequences, including preventable injuries, fatalities, and increased healthcare costs. Emerging approaches, such as drowsiness monitoring and detection systems, may improve real-time driver awareness and enhance safety outcomes. However, technology alone is insufficient without behavior-focused strategies that address underlying determinants of fatigue-related driving. This highlights the importance of targeted educational and behavioral interventions that promote safe sleep practices and strengthen students' ability to recognize and respond to warning signs of fatigue.

Research indicates that many students fail to fully recognize how fatigue affects driving performance, increasing their risk of unsafe decisions. University-based workshops that emphasize sleep hygiene and the direct relationship between adequate sleep and driving safety may help students better assess fatigue and adopt safer behaviors. Such interventions can enhance well-being and reduce preventable harm.

Study Design This study will employ an educational randomized controlled trial (RCT) design to evaluate the effectiveness of a theory-driven intervention in reducing drowsy driving among college students. Random assignment to two study arms will be used to ensure that participants in the experimental group (receiving the Multi-Theory Model [MTM]-based intervention) and the comparison group (completing the standard American Automobile Association [AAA] online certification course) are comparable at baseline. This design will strengthen internal validity by reducing selection bias and distributing known and unknown confounders evenly across groups.

The primary purpose of the study is to compare the MTM-based intervention with a standard AAA program in reducing self-reported drowsy driving behaviors. Participants will complete surveys at three time points: baseline (pretest), immediately after the four-week intervention (post-test), and two weeks after completion (follow-up). These assessments will evaluate changes in drowsy driving frequency, intention to initiate and sustain safer driving behaviors, and the six MTM constructs.

Randomization will be conducted using a computer-generated sequence with stratification by key demographic variables such as gender and academic level to ensure balanced representation across groups. This trial is informed by prior findings indicating that nearly 50% of college students reported drowsy driving in the past month, highlighting the urgency of targeted prevention strategies. In the same study, participatory dialogue and behavioral confidence significantly predicted initiation of behavior change, while emotional transformation and practice for change predicted sustenance; changes in the physical and social environments were not significant predictors, suggesting that individual-level approaches may be particularly relevant.

Participants in the intervention arm will receive structured MTM-based activities delivered across four weekly sessions, while those in the comparison arm will complete the AAA online certification course. Because the AAA course requires approximately five hours, both conditions will be matched for time and delivered across four sessions to maintain consistent intervention dosage. A follow-up assessment will be conducted in week six to evaluate maintenance of outcomes. All participants will receive an incentive after completing the final follow-up survey.

Target Population and Sampling Strategies The target population for this study will include college students enrolled at a university in Nevada. Eligible participants must be at least 18 years of age, currently enrolled in an undergraduate or graduate program, and able to provide informed consent. This study will follow a randomized controlled trial (RCT) design consistent with CONSORT guidelines to ensure methodological rigor and transparent reporting. Interested students will be directed to an online screening survey, where eligibility will be assessed following informed consent procedures. Students who meet the inclusion criteria will be enrolled and complete a baseline assessment before randomization.

After baseline data collection, participants will be randomly assigned to one of two study arms: (1) the experimental group receiving the Multi-Theory Model (MTM)-based intervention or (2) the comparison group completing the standard American Automobile Association (AAA) program-based intervention. Randomization will be conducted using a computer-generated allocation sequence to reduce selection bias and ensure comparability between groups.

Sample size will be determined through a priori power analysis using G*Power Version 3.1.9.7 for Windows. Assuming an alpha level of 0.05, power of 0.80, and a medium effect size of 0.30, the required sample size is estimated at 60 participants. To account for attrition and inclusion of covariates, the sample will be increased by 20%, resulting in a final target sample size of 72 participants.

Instrumentation Evidence supporting the reliability of this instrument is drawn from a prior cross-sectional study that administered a closely related 42-item web-based survey to 725 college students. That study demonstrated strong internal consistency across the MTM subscales and the overall measure: Cronbach's α = 0.88 (Perceived Advantages), 0.78 (Perceived Disadvantages), 0.81 (Behavioral Confidence), 0.87 (Changes in Physical Environment), 0.90 (Emotional Transformation), 0.83 (Practice for Change), 0.83 (Changes in Social Environment), 0.86 (Initiation scale), 0.92 (Sustenance scale), and 0.93 (overall MTM scale) Internal Consistency and Construct Validity Cronbach's alpha values, along with their 95% confidence intervals (CIs), were reported for all scales used in the instrument. Each alpha value surpassed the 0.70 benchmark, indicating that the scales and subscales developed to measure initiation and sustenance processes demonstrated satisfactory internal consistency. The results are presented in Table 1.

Scale Cronbach's Alpha (95% CI) Perceived Advantage 0.88 (0.86, 0.91) Perceived Disadvantage 0.78 (0.75, 0.81) Behavioral Confidence 0.81 (0.79, 0.84) Changes in the Physical Environment 0.87 (0.84, 0.89) Overall Initiation Scale 0.86 (0.83, 0.89) Emotional Transformation 0.90 (0.88, 0.92) Practice for Change 0.83 (0.80, 0.86) Changes in the Social Environment 0.83 (0.80, 0.86) Overall Sustenance Scale 0.92 (0.90, 0.94) Overall Scale 0.93 (0.91, 0.95) Table-1 Internal consistency of the initiation and sustenance scales and subscales.

The majority of fit indices used to evaluate the overall adequacy of the initiation model met the standard criteria for acceptable model fit. The estimated values included an RMSEA of 0.08, SRMR of 0.06, and CFI of 0.90, with the TLI at 0.88 slightly below but near the acceptable cutoff. The standardized factor loadings were found to range between 0.40 and 0.93.

Figure-1 Structural equation model for the initiation of safe driving behavior. For clarity of interpretation, only parameter estimates that reached statistical significance are shown.

These results demonstrated that the initiation scale effectively captured its intended constructs, namely, perceived advantages, perceived disadvantages, behavioral confidence, and changes in the physical environment. Among these, perceived advantages, behavioral confidence, and changes in the physical environment showed small to moderate, positive, and statistically significant direct effects on the initiation of safe driving behavior, with effect sizes ranging from 0.08 to 0.58.

Similarly, increases in emotional transformation and changes in the social environment were associated with greater sustenance of safe driving behavior. However, the construct "practice for change" did not show a significant effect on sustaining this behavior. Despite this, there were significant interrelationships among emotional transformation, practice for change, and changes in the social environment.

For the sustenance model, the overall model fit was excellent, as indicated by the fit indices: CFI = 0.99, TLI = 0.94, RMSEA = 0.05, and SRMR = 0.02. Standardized factor loadings for the sustenance scale ranged from 0.61 to 0.92, supporting its validity in measuring emotional transformation, practice for change, and changes in the social environment. Emotional transformation and social environment changes had small to moderate and statistically significant effects on sustaining safe driving behavior, with effect sizes of 0.50 and 0.17.

Figure-2 Structural equation model for the sustenance of safe driving behavior. For conceptual clarity, only the statistically significant parameter estimates are presented.

This indicates that higher levels of emotional transformation and changes in the social environment were associated with greater maintenance of safe driving behavior. However, practice for change did not have a significant impact on sustaining this behavior. Nonetheless, significant associations were observed among emotional transformation, practice for change, and changes in the social environment.

MTM-based intervention (Stay Awake, Stay Alive©) The intervention is grounded in the Multi-Theory Model (MTM) and targets both initiation and sustenance of behavior change.

To support initiation, participatory dialogue will be facilitated through guided group discussions in which students identify perceived benefits and challenges of reducing drowsy driving. This will be complemented by a brief educational lecture and interactive debate using case studies and real-life scenarios to help participants weigh advantages versus disadvantages. Behavioral confidence will be strengthened through a short psychodrama film illustrating the consequences of drowsy driving, followed by structured reflection and discussion focused on barriers and practical strategies such as improving sleep habits, proactive trip planning, selecting a designated driver, and seeking social support. Changes in the physical environment will be addressed by introducing campus and community resources (e.g., transportation services, student health services) and engaging participants in brainstorming how to access and apply these supports, including creating a personalized resource map.

To support sustenance, emotional transformation will be cultivated through a psychodrama video featuring successful real-life behavior change stories, followed by reflection on emotions and motivation-building strategies. Practice for change will be reinforced through weekly sleep journaling and progress reviews, with guidance to modify routines and reduce risk. Finally, changes in the social environment will be promoted using peer support groups, accountability partners, and role-playing exercises to build supportive communication and sustained behavior change.

Study Procedure This study will undergo review and approval by the Institutional Review Board (IRB) at the University of Nevada, Las Vegas (UNLV) to ensure compliance with ethical standards for the protection of human subjects. Participant recruitment will occur on campus-wide through multiple outreach strategies, including electronic communications, printed flyers, and structured campus engagement efforts. All intervention sessions will be conducted at the School of Public Health at UNLV and facilitated by the principal investigator, who maintains certification in human subjects' research through the Collaborative Institutional Training Initiative (CITI) program.

Following baseline assessment, participants will be randomly allocated to one of two study arms: an experimental group receiving the Multi-Theory Model (MTM)-based, theory-driven intervention or a comparison group receiving a knowledge-based intervention modeled after the American Automobile Association (AAA) program. Randomization will be conducted using the Statistical Package for the Social Sciences (SPSS) software to generate a computer-based allocation sequence, thereby minimizing selection bias and supporting internal validity.

A research assistant trained and certified through the CITI program will supervise participant check-in procedures and monitor attendance across all sessions. The assistant will also provide logistical and administrative support, including preparation of intervention materials, distribution of educational resources related to drowsy driving prevention, and facilitation assistance during MTM-based activities in the experimental arm. The trial will be implemented and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines to ensure methodological rigor and transparency.

Interventions The experimental group will receive the Multi-Theory Model (MTM) based intervention, delivered by the principal investigator. Beyond structured educational content, the intervention will integrate experiential and participatory learning strategies designed to enhance engagement and promote behavior change. These strategies will include role-playing exercises, video-based dramatizations illustrating real-world consequences of drowsy driving, guided reflective journaling, and facilitated peer discussions. Participants will be instructed to monitor and record nightly sleep duration and any occurrences of drowsy driving using a structured sleep journal. In addition, they will document emotional and situational triggers associated with fatigue and discuss these reflections during weekly group sessions to support self-awareness and self-regulation.

At the outset of the program, each participant in the experimental group will receive a safety resource kit designed to reinforce environmental support for behavior change. The kit will include a sleep mask, information on local public transportation routes, resources for obtaining a bus pass, a personal journal, and educational materials related to drowsy driving prevention. Upon completion of the intervention and submission of the follow-up assessment, participants will receive a gift card as compensation for their time and participation.

Participants assigned to the comparison group will complete a five-hour online educational program focused on drowsy driving prevention, modeled after the American Automobile Association (AAA) curriculum. The course will be structured into four sessions of approximately 75 minutes each, matching the duration and contact time of the experimental intervention to maintain consistency in exposure. All sessions will be conducted under investigator's supervision. The course fee will be covered by the study team. The comparison intervention will be administered using desktop computers and audio equipment provided by the School of Public Health. Upon successful completion of the program, participants will receive a certificate of completion, a gift card, and a drowsy driving prevention resource kit.

Process Evaluation Using the RQFSM Model The RQFSM model, comprising Reach, Quality, Fidelity, Satisfaction, and Maintenance, will be employed as a structured framework to guide the process evaluation of the proposed public health intervention. This model enables systematic assessment of implementation-related dimensions to complement outcome evaluation measures. Within this theory-driven intervention designed to reduce drowsy driving among college students using MTM constructs, the RQFSM model will provide a comprehensive mechanism for evaluating implementation processes alongside behavioral outcomes. Behavioral interventions are highly dependent on delivery quality, participant engagement, and adherence to theoretical constructs. Therefore, the RQFSM framework will facilitate a multidimensional assessment of program implementation, ensuring that conclusions regarding effectiveness are interpreted within the context of implementation integrity and sustainability rather than outcome data alone.

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89119
        • University of Nevada Las Vegas

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusiecriteria

  • Student ingeschreven aan een universiteit in Nevada
  • Leeftijd ≥ 18 jaar
  • Momenteel ingeschreven in een bachelor- of masteropleiding
  • In staat om geïnformeerde toestemming te geven
  • Voldoet aan de "geschiktheidsscreener"-items met betrekking tot eerder slaperig rijden

Exclusiecriteria

  • Zakt voor de initiële geschiktheidsscreener voor slaperig rijden
  • Medische/slaapstoornissen (bijv., obstructieve slaapapneu) worden bewust uitgesloten

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MTM-gebaseerde interventie
In deze arm zullen deelnemers een 4-weeks educatief programma volgen dat wordt aangeboden in wekelijkse groepsessies (elk ongeveer 75 minuten, inclusief een pauze van 5 minuten). De sessies zullen ervaringsgerichte leermethoden omvatten, zoals rollenspellen, videodramatiseringen, reflectief dagboek schrijven en groepsdiscussies. Deelnemers zullen een verstrekt slaapdagboek gebruiken om de nachtelijke slaapduur en eventuele episodes van slaperig rijden vast te leggen. Ze zullen ook emotionele of situationele triggers met betrekking tot vermoeidheid noteren en belangrijke reflecties bespreken tijdens de wekelijkse groepsdiscussies. De inhoud van de sessies zal de belangrijkste concepten van het Multi-Theory Model (MTM) behandelen om gedragsverandering te ondersteunen.
In deze arm zullen deelnemers een 4-weekse educatieve interventie bijwonen, aangeboden in wekelijkse groepsessies (elk ongeveer 75 minuten, inclusief een pauze van 5 minuten). De sessies zullen ervaringsgerichte leerstrategieën bevatten, zoals rollenspellen, videodramatiseringen, reflectief dagboek schrijven en groepsdiscussies. Deelnemers zullen een verstrekt slaapdagboek gebruiken om de nachtelijke slaapduur en eventuele slaperige rijepisodes vast te leggen. Ze zullen ook emotionele of situationele triggers met betrekking tot vermoeidheid noteren en belangrijke reflecties bespreken tijdens wekelijkse groepsdiscussies. De inhoud van de sessies zal de belangrijkste constructen van het Multi-Theory Model (MTM) behandelen om gedragsverandering te ondersteunen.
Actieve vergelijker: Standaard AAA Kennis gebaseerd
Deelnemers in de AAA (American Automobile Association) interventie (vergelijking) groep zullen een 5 uur durende online cursus volgen gericht op het voorkomen van vermoeid rijden. De cursus zal worden gegeven in vier sessies, elk ongeveer 75 minuten lang, overeenkomend met de sessieduur van de experimentele arm. Alle sessies zullen worden voltooid onder toezicht van de onderzoeker en door CITI opgeleid onderzoekspersoneel.
Deelnemers in de AAA (American Automobile Association) interventie (vergelijking) groep zullen een online cursus van 5 uur voltooien die gericht is op het voorkomen van vermoeidheidsrijden. De cursus wordt aangeboden in vier sessies, elk ongeveer 75 minuten lang, wat overeenkomt met de sessieduur van de experimentele arm. Alle sessies worden voltooid onder toezicht van de onderzoeker en door CITI opgeleid onderzoekspersoneel.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Verandering ten opzichte van de baseline in het aantal dagen van zelfgerapporteerd slaperig rijden in de afgelopen 14 dagen
Tijdsspanne: Baseline (Week 0), direct na de interventie (Week 4), en follow-up (Week 6)
Zelfgerapporteerd aantal dagen (0-14) waarop deelnemers de afgelopen 14 dagen hebben gereden terwijl ze zich slaperig of vermoeid voelden. Deelnemers rapporteren de frequentie van slaperig rijden met behulp van een gestructureerde surveyvraag die gedrag beoordeelt over een herinneringsperiode van twee weken.
Baseline (Week 0), direct na de interventie (Week 4), en follow-up (Week 6)
Verandering vanaf baseline in intentie om reductie van slaperig rijden te initiëren (MTM Initiëringsschaalscore)
Tijdsspanne: Baseline (Week 0), direct na interventie (Week 4), en follow-up (Week 6)
De intentie om te beginnen met het stoppen van vermoeid rijden, gemeten met een enkele Likert-type vraag die de waarschijnlijkheid beoordeelt om in de komende week pogingen te starten om vermoeid rijden te stoppen. Antwoordopties variëren van 0 (Helemaal niet waarschijnlijk) tot 4 (Volledig waarschijnlijk); het totaalscorebereik is 0 tot 4.
Baseline (Week 0), direct na interventie (Week 4), en follow-up (Week 6)
Verandering vanaf baseline in intentie om vermindering van slaperig rijden te handhaven (MTM Sustenance Scale Score)
Tijdsspanne: Baseline (Week 0), direct na interventie (Week 4) en follow-up (Week 6)
De intentie om het stoppen met slaperig rijden vol te houden, gemeten met een enkele Likert-schaal item die de waarschijnlijkheid beoordeelt om vanaf nu te stoppen met slaperig rijden. Antwoordopties variëren van 0 (Helemaal niet waarschijnlijk) tot 4 (Volledig waarschijnlijk); het totale scorebereik is 0 tot 4.
Baseline (Week 0), direct na interventie (Week 4) en follow-up (Week 6)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: MANOJ SHARMA, University of Nevada, Las Vegas

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 april 2026

Primaire voltooiing (Geschat)

30 augustus 2026

Studie voltooiing (Geschat)

7 september 2026

Studieregistratiedata

Eerst ingediend

10 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 februari 2026

Eerst geplaatst (Werkelijk)

27 februari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

21 mei 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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