- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07434921
TEST DI UN'INTERVENTO BASATO SULLA TEORIA MTM SULLA RIDUZIONE DELLA GUIDA ASSONNATA, "STAY AWAKE, STAY ALIVE ©," TRA GLI STUDENTI UNIVERSITARI
TEST DI UN'INTERVENTO BASATO SULLA TEORIA MTM PER RIDURRE IL COMPORTAMENTO DI GUIDA ASSONNATA, "STAY AWAKE, STAY ALIVE, ©" TRA GLI STUDENTI UNIVERSITARI: UNO STUDIO RANDOMIZZATO CONTROLLATO EDUCATIVO
L'obiettivo di questo studio educativo controllato randomizzato è di verificare se un programma strutturato e basato sulla teoria possa aiutare a ridurre la guida in stato di sonnolenza tra gli studenti universitari (di età pari o superiore a 18 anni) in Nevada. La guida in stato di sonnolenza significa guidare quando si è molto assonnati, stanchi o si fatica a rimanere vigili. Si tratta di un grave problema di sicurezza perché può rallentare i tempi di reazione, ridurre l'attenzione e aumentare il rischio di incidenti, infortuni e persino decessi. Molti studenti universitari hanno orari di sonno irregolari a causa di lezioni, lavoro, studio notturno e attività sociali, il che può aumentare la stanchezza e la probabilità di guidare in stato di sonnolenza.
Domanda di ricerca
- Esiste una differenza statisticamente e praticamente significativa nel punteggio medio del comportamento di guida in stato di sonnolenza nel gruppo sperimentale (intervento basato sul Multi-Theory Model (MTM), Stay Awake, Stay Alive©) e nel gruppo di confronto (intervento basato sul programma standard AAA (American Automobile Association)) dal pre-intervento al post-intervento fino al follow-up di due settimane
- Esiste una differenza statisticamente e praticamente significativa nel punteggio medio (dal pre-intervento al post-intervento fino al follow-up di due settimane) per l'intenzione di iniziare a ridurre la guida in stato di sonnolenza tra i gruppi sperimentale (intervento basato su MTM, Stay Awake, Stay Alive©) e di confronto (intervento basato sul programma standard AAA)?
- Esiste una differenza statisticamente e praticamente significativa nel punteggio medio (dal pre-intervento al post-intervento fino al follow-up di due settimane) per l'intenzione di mantenere la riduzione della guida in stato di sonnolenza tra i gruppi sperimentale (intervento basato su MTM, Stay Awake, Stay Alive©) e di confronto (intervento basato sul programma standard AAA)?
I ricercatori confronteranno due gruppi per vedere quale approccio porta a un miglioramento maggiore:
Gruppo 1: Programma "Stay Awake, Stay Alive" basato su MTM (sessioni interattive settimanali progettate utilizzando la teoria del cambiamento comportamentale).
Gruppo 2: Programma standard di educazione alla guida in stato di sonnolenza, educazione basata su AAA (American Automobile Association).
Confrontando questi gruppi, i ricercatori possono vedere se il programma basato su MTM fornisce un beneficio aggiuntivo oltre alla sola educazione standard. Entrambi i gruppi ricevono lo stesso tempo e la stessa attenzione complessivi, quindi le differenze nei risultati possono essere collegate più chiaramente alle strategie del programma piuttosto che al semplice ricevere educazione.
I partecipanti:
- Completeranno un breve screening per confermare l'idoneità (ad esempio, avere 18 anni o più e aver avuto esperienze recenti di guida in stato di sonnolenza)
- Forniranno il consenso informato prima che inizino le attività dello studio
- Saranno assegnati casualmente a uno dei due programmi
- Parteciperanno a quattro sessioni settimanali (circa 75 minuti ciascuna) per 4 settimane, con una breve pausa e rinfreschi durante le sessioni
- Completeranno sondaggi in tre momenti: Baseline (prima dell'inizio del programma), Post-intervento (dopo la settimana 4) e Follow-up (dopo due settimane)
- Risponderanno a domande sul loro comportamento di guida in stato di sonnolenza e sulle influenze correlate, come fattori scatenanti della fatica, ostacoli al sonno, fiducia nell'evitare di guidare quando si è assonnati e supporti che rendono più facili le scelte sicure.
Lo studio misurerà i cambiamenti nel comportamento di guida in stato di sonnolenza e nei fattori correlati al MTM che possono spiegare perché questi cambiamenti si verificano. Ad esempio, il programma basato su MTM aiuta gli studenti a riflettere sui benefici di evitare la guida in stato di sonnolenza (e sui rischi di continuarla), a costruire una fiducia comportamentale per scegliere opzioni più sicure e a identificare supporti ambientali pratici (come un luogo sicuro per riposare, chiedere un passaggio a un amico, utilizzare il ridesharing o i trasporti pubblici o adeguare l'orario del viaggio). Supporta anche la trasformazione emotiva (trasformare la preoccupazione in motivazione), la pratica per il cambiamento (stabilire obiettivi e monitorare i progressi) e la costruzione di un ambiente sociale di supporto (amici e familiari che incoraggiano scelte più sicure).
Durante le sessioni, i partecipanti possono apprendere e praticare abilità del mondo reale come riconoscere i primi segnali di allarme della sonnolenza (palpebre pesanti, frequenti sbadigli, deriva di corsia, uscite mancate), utilizzare brevi pause di riposo e piani sicuri di "fermata", gestire gli orari per ridurre la guida notturna e creare un piano d'azione personale per situazioni ad alto rischio (dopo turni di lavoro, lunghe notti di studio o viaggi a lunga distanza). Il sondaggio di follow-up aiuta i ricercatori a vedere se eventuali miglioramenti continuano oltre la fine del programma di 4 settimane.
Alla fine dello studio, i risultati aiuteranno le università, i professionisti della salute pubblica e i programmi di sicurezza stradale a capire quali tipi di educazione sono più efficaci per prevenire la guida in stato di sonnolenza nei giovani adulti. Se il programma basato su MTM è efficace, potrebbe essere adattato e utilizzato più ampiamente per migliorare la sicurezza degli studenti e ridurre gli infortuni legati alla guida in stato di sonnolenza. I partecipanti che completeranno il sondaggio di follow-up finale riceveranno un incentivo.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
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.
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.
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.
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.
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.
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.
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.
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.
- 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.
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89119
- University of Nevada Las Vegas
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Criteri di inclusione
- Studente universitario iscritto in un'università del Nevada
- Età ≥ 18 anni
- Attualmente iscritto a un programma di laurea triennale o magistrale
- In grado di fornire il consenso informato
- Soddisfa i requisiti dello "screener di idoneità" relativi alla precedente guida in stato di sonnolenza Criteri di esclusione
- Non supera lo screener iniziale di idoneità per la guida in stato di sonnolenza
- Disturbi medici/del sonno (ad esempio, apnea ostruttiva del sonno) sono deliberatamente esclusi
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Intervento basato su MTM
In questo braccio, i partecipanti parteciperanno a un intervento educativo di 4 settimane erogato in sessioni di gruppo settimanali (circa 75 minuti ciascuna, inclusa una pausa di 5 minuti).
Le sessioni incorporeranno strategie di apprendimento esperienziale come role-play, drammatizzazioni video, diario riflessivo e discussioni tra pari.
I partecipanti utilizzeranno un diario del sonno fornito per registrare la durata del sonno notturno e eventuali episodi di guida in stato di sonnolenza.
Prenderanno anche nota di fattori scatenanti emotivi o situazionali legati alla fatica e discuteranno le riflessioni chiave durante le discussioni di gruppo settimanali.
Il contenuto delle sessioni affronterà i costrutti chiave del Multi-Theory Model (MTM) per supportare il cambiamento comportamentale.
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In questo braccio, i partecipanti parteciperanno a un intervento educativo di 4 settimane erogato in sessioni di gruppo settimanali (circa 75 minuti ciascuna, inclusa una pausa di 5 minuti).
Le sessioni incorporeranno strategie di apprendimento esperienziale come role-play, drammatizzazioni video, journaling riflessivo e discussioni tra pari.
I partecipanti utilizzeranno un diario del sonno fornito per registrare la durata del sonno notturno e eventuali episodi di guida assonnata.
Prenderanno anche nota di fattori scatenanti emotivi o situazionali legati alla fatica e discuteranno le riflessioni chiave durante le discussioni di gruppo settimanali.
Il contenuto delle sessioni affronterà i costrutti chiave del Multi-Theory Model (MTM) per supportare il cambiamento comportamentale.
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Comparatore attivo: Standard AAA Knowledge based
I partecipanti del gruppo di intervento (confronto) AAA (American Automobile Association) completeranno un corso online di 5 ore incentrato sulla prevenzione della guida in stato di sonnolenza.
Il corso sarà erogato in quattro sessioni, ciascuna della durata di circa 75 minuti, corrispondente alla durata delle sessioni del braccio sperimentale.
Tutte le sessioni saranno completate sotto la supervisione dello sperimentatore e del personale dello studio formato CITI.
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I partecipanti nel gruppo di intervento (confronto) AAA (American Automobile Association) completeranno un corso online di 5 ore incentrato sulla prevenzione della guida in stato di sonnolenza.
Il corso sarà erogato in quattro sessioni, ciascuna della durata di circa 75 minuti, corrispondente alla durata delle sessioni del braccio sperimentale.
Tutte le sessioni saranno completate sotto la supervisione dello sperimentatore e del personale di studio formato CITI.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Variazione rispetto al basale nel numero di giorni di guida in stato di sonnolenza auto-riferita negli ultimi 14 giorni
Lasso di tempo: Baseline (Settimana 0), immediatamente post-intervento (Settimana 4), e follow-up (Settimana 6)
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Numero di giorni (0-14) auto-riferito durante i quali i partecipanti hanno guidato avvertendo sonnolenza o affaticamento nei precedenti 14 giorni.
I partecipanti riferiranno la frequenza degli episodi di guida in stato di sonnolenza utilizzando un elemento di indagine strutturato che valuta il comportamento in un periodo di richiamo di due settimane.
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Baseline (Settimana 0), immediatamente post-intervento (Settimana 4), e follow-up (Settimana 6)
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Variazione rispetto al basale nell'intenzione di avviare la riduzione della guida in stato di sonnolenza (Punteggio Scala di Avvio MTM)
Lasso di tempo: Baseline (Settimana 0), immediatamente dopo l'intervento (Settimana 4) e follow-up (Settimana 6)
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L'intenzione di iniziare a fermare la guida in stato di sonnolenza misurata utilizzando un singolo elemento di tipo Likert che valuta la probabilità di iniziare i tentativi di fermare la guida in stato di sonnolenza nella settimana successiva. Le opzioni di risposta vanno da 0 (Per nulla probabile) a 4 (Completamente probabile); il punteggio totale varia da 0 a 4.
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Baseline (Settimana 0), immediatamente dopo l'intervento (Settimana 4) e follow-up (Settimana 6)
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Variazione rispetto al basale nell'intenzione di mantenere la riduzione della guida in stato di sonnolenza (Punteggio della Scala di Mantenimento MTM)
Lasso di tempo: Baseline (Settimana 0), immediatamente dopo l'intervento (Settimana 4) e follow-up (Settimana 6)
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L'intenzione di mantenere l'interruzione della guida in stato di sonnolenza, misurata utilizzando un singolo item di tipo Likert che valuta la probabilità di interrompere la guida in stato di sonnolenza da ora in poi.
Le opzioni di risposta vanno da 0 (Per niente probabile) a 4 (Completamente probabile); il punteggio totale varia da 0 a 4.
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Baseline (Settimana 0), immediatamente dopo l'intervento (Settimana 4) e follow-up (Settimana 6)
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: MANOJ SHARMA, University of Nevada, Las Vegas
Pubblicazioni e link utili
Pubblicazioni generali
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- American Academy of Sleep Medicine. (2024). Sleepy driving highly prevalent among college students. https://aasm.org/sleepy-driving-highly-prevalent-among-college-students/
- 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.
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UNLV-2025-627
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .