30 Clinical Trials for Various Conditions
This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design.
This is an extension of a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. The purpose of this extension is to add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with EMDR and PC.
This is a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. Participants will be assigned to the geographically nearest therapist, and then randomized to treatment condition.
The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment for concussion.
Chronic problems after traumatic events are common in non-elderly adults. Previous studies have shown that after minor motor vehicle collision (MVC), 10-30% of non-elderly adult patients develop chronic regional pain (neck or back pain). In addition, up to 1/3 of non-elderly adults will develop psychological sequelae, including posttraumatic stress disorder, depression, and anxiety disorders. There have been no prospective studies examining the frequency or predictors of persistent pain or psychological sequelae in older adults. The proposed study seeks to determine the frequency of persistent pain, psychological sequelae, and associated disability in older adults after minor MVC trauma and to identify candidate predictors for a model of adverse outcomes after MVC in this population. 200 individuals over 65 years of age will be recruited from emergency departments in four states with no-fault accident laws. Patients who meet inclusion criteria and who consent to the emergency department (ED) study will undergo a 30-45 minute ED assessment of crash-related, psychosocial, and biological factors, and complete telephone follow-ups at 2 weeks, 6 weeks 6 months, and 12 months. The wealth of information gained from this study will be used to determine the frequency of adverse events in older adults after MVC and to identify high risk elderly patients. These results will inform subsequent development of secondary pharmacologic and/or behavioral interventions to prevent chronic pain and psychological sequelae after traumatic events in older adults.
Background: * Automobile crash risks are highest right after licensure and decline rapidly for about 6 months and then gradually for years, regardless of the amount of supervised practice driving or age at licensure. The only approaches to this problem that have demonstrated effectiveness are Graduated Driver Licensing (GDL) and parental management. * The Checkpoints Program consists of persuasive messages and materials designed to increase adoption of the Checkpoints Parent-Teen Driving Agreement and to improve parents' ability to set limits on higher-risk driving privileges for novice drivers. Researchers are interested in determining whether expanding the Checkpoints Program to an online version (instead of through the mail) can help improve parent limit-setting in connection with the program. Objectives: * To determine the feasibility and effectiveness of conducting an online version of the Checkpoints Program through American Automobile Association (AAA) clubs. * To test rates of parental intervention and limit-setting after participation in the Checkpoints Program. Eligibility: - Parents whose teenage children are enrolled in AAA-affiliated driving schools. Design: * Parents with children at the permit stage of driver's education will be recruited through AAA clubs and will be asked to visit a designated Web site to sign up for the program. * Parents will provide consent and complete the baseline survey, and will be assigned to random groups to test different versions of the Checkpoints Program (the intervention or a control group Web site). * The intervention program will contain videos, regular e-mails, and newsletters on setting parental limits and information on specific teen driving risks. The control program will provide information on various topics related to the licensing procedure and safe driving, but no specific information on teen driving risks. * A follow-up assessment will be conducted 1 month after the teenager receives his or her license.
Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. A new type of swivel car seat is being developed to potentially alleviate some of the typical frustrations that might lead to car seat misuse, specifically the visibility and usage of the top tether feature. This study aims to evaluate the new car seat product and determine whether the new design results in fewer installation errors compared to a traditional car seat. Primary objective: To compare the number of top tether installation errors produced with a production-ready prototype swivel child safety seat vs. a traditional (control) seat. Secondary objective: To assess self-reported preference and opinions on the swivel child safety seat design.
This study will test an intervention that was developed to improve parents\' driving instruction of teens\' hazard anticipation skills when teens are in the learner phase of licensure. Half of the parents in the study will receive the intervention and half will not. Investigators will then compare driving instructions given by parents in the two groups by recording driving sessions that parents and teens have together in that real world and by recording a drive that parents and teens will complete in a driving simulator. The driving simulator allows us to expose teens and parents to hazards they may encounter on the roadway without putting them in harm\'s way.
The purpose of this study is to assess the effectiveness of child passenger educational methods to measure their ability to effectively reduce car seat misuse. The study will assess the traditional child passenger educational method delivered by a child passenger safety technician by comparing it to an in-person and virtual telehealth Behavioral Skills Training approach to reduce car seat misuse.
This randomized controlled trial will evaluate an intervention that provides parents with objective feedback about their teen's driving as well as strategies to improve communication with their teen about driving. We will recruit 180 newly-licensed teen drivers and a parent or guardian. Our main hypotheses are that: parent-teen dyads who receive feedback will have reduced driving errors and increased safety behaviors than dyads with no feedback; and, parent-teen dyads who receive instruction on communication techniques will have improved quality and quantity of communication about driving than dyads not learning these techniques.
We hypothesize that this intervention will increase the quality and quantity of parental interaction on safety driving with newly-licensed teen drivers. 250 parent/teen dyads will be individually randomized into intervention and control groups. The intervention group will receive a tailored, in-person intervention with a trained member of the research team, with follow-up intervention phone calls each month for the 3-month intervention. The control group will be a "usual care" group who will receive driving safety materials available to all new drivers and their parents. Parents and teens will be followed to see if intervention parents meet the intervention's driving goals and to see if the parent and teens report improved driving skills and behaviors in the intervention compared with the control group.
This study, conducted at the University of Massachusetts at Amherst, will examine how male teenage driving performance varies in the presence or absence of male teenage passengers. It will explore what information teen drivers and their passengers use when making decisions that affect their performance on the road. Male drivers under 18 years of age who have a Junior Operator's or Full License and have driven at least once in the month before enrolling in the study may be eligible to participate. In a university laboratory, participants sit in a 1995 Saturn sedan and operate the controls of the car just as they would those of any other car, during simulated drives in urban, suburban and rural areas. They are fitted with a head-mounted eye tracker that records their point of gaze in real time. On one drive, the subject drives alone; on another, a male passenger rides along. After the drives, the subject fills out some questionnaires.
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
Truckers face many unique challenges in their work that may adversely impact their health, including time constraints, sedentary job tasks, and a 'moving-workplace' environment with associated limitations to access healthy food and safe places to be physically active. These issues make it difficult to form and maintain healthy lifestyle habits and contribute to the high prevalence of injuries from both crashes and falls among truckers is supported by an increase in obesity among truckers with longer durations of employment. The investigators propose to develop and pilot test the Exercise Intervention of the Worksite Health, Eating and Exercising for the Long-haul (WHEEL)'s weight loss intervention. This pilot exercise intervention is aimed at achieving meaningful improvement in grip strength, balance, and gait over 6 weeks. The investigators will use pilot sample of 15 obese (BMI ≥ 30 kg/m2) truckers, documenting changes in these measures. Individualized assessments will be utilized. The investigators will aim to complete the following: 1. Evaluate the feasibility of the PIE WHEEL intervention for CMV drivers will result in greater strength comparing baseline with 6 week outcomes. 1. Determine the extent to which drivers will participate in PIE WHEEL 2. Determine the extent of change in strength, balance and gait realized by PIE WHEEL participation 2. Evaluate safety events (crashes, near misses, falls) in the week prior to PIE WHEEL and the final week of PIE WHEEL a. Solicit driver perceptions of their own safety of ingress and egress related to PIE WHEEL participation
Research participants and their parents will be recruited to take part in a randomized control trial. Participants' and their parents' cellphone use will be observed during an initial baseline period. Participants and their parents will then be randomly assigned to one of two conditions: opt-out blocking with parental notification, opt-out blocking with bidirectional notification.
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.
Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days.
African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N 56th St Ste100, Omaha, for CRC screening. All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls, and post-FIT navigation support for participants with positive results or without family doctor/insurance. Kits are returned to a designated Nebraska Medicine lab for testing, and test results will be mailed to participants within 14-21 days. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube to increase awareness and potentially improve participation rates. The study will compare FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results between the two groups.
The main objective of this study is to determine whether the administration of a single dose of Vitamin D in the Emergency Department following a motor vehicle collision can improve musculoskeletal pain severity as well as reduce musculoskeletal pain outcome disparity between Blacks and White following a motor vehicle collision. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy (response to study drug, ability to reduce racial disparity in pain outcomes). This data can be used to adequately power a larger randomized controlled trial to fully assess efficacy.
The overarching objective of this study is to investigate the use of antagonistic actions as a treatment augmentation strategy for enhancing emotional processing during exposure to trauma-relevant stimuli. To accomplish this, participants (N = 84) reporting exposure to a combat, sexual assault, physical assault, or motor vehicle accident Criterion A trauma will be randomized to one of three experimental conditions: (a) Psychoeducation alone (PSYED); (b) Psychoeducation followed by repeated exposure to trauma-videoclips (PSYED + EXP); or (c) Psychoeducation followed by repeated exposure to trauma-videoclips while engaging in antagonistic actions (PSYED + EXP + AA). Antagonistic action strategies during exposure to the trauma-videoclips will include (a) adopting an open posture; (b) eating a palatable snack; (c) smiling; and (d) wishing on high levels of emotional distress. The investigators expect that (a) those randomized to receive psychoeducation alone will show less improvement relative to the two groups that receive psychoeducation plus repeated exposure to trauma-videoclips; (b) those receiving psychoeducation in combination with repeated exposure to trauma-videoclips while performing antagonistic actions will show significantly enhanced treatment outcome at the one-month follow-up relative to the other two treatment arms; (c) participants with greater PTSD symptom severity are likely to have a poorer treatment outcome to PSYED alone; (d) changes in trauma-related threat appraisals, coping self-efficacy, and safety behaviors will each independently mediate the effects of treatment; and (e) participants displaying reductions in their emotional reactivity are more likely to have a reduction in PTSD symptoms.
The long-term goal of this pragmatic, cluster randomized study is to develop a sustainable program for healthcare systems to reduce fatal and nonfatal falls among high-risk older adults living independently in their communities. This study will examine how a medication care plan, grounded in established medication deprescribing and tapering frameworks, can be implemented in primary care clinics to reduce falls among older adults living in rural Iowa communities. The study is a collaboration between researchers and clinical pharmacists at the University of Iowa and a clinical team from the MercyOneSM Health Network, which is a non-academic healthcare system with significant reach into rural Iowa communities The study's specific goals are as followed: * Aim 1: Examine the effectiveness of a clinic-based, individualized medication care plan in reducing rates of all falls including medically treated falls (sub-aim 1a) and motor vehicle charges and crashes (sub-aim 1b) among older adults seen in rural primary care clinics. * Aim 2: Identify provider and patient factors that are associated with patient adherence to medication deprescribing and discontinuation recommendations. * Aim 3\*: Evaluate implementation of the medication care plan to understand its acceptability, usability and relevance among healthcare system administrators, clinics (clinic managers and clinical staff), providers (health coaches, pharmacists, prescribers) and patients. Note\*: Only Aims 1 and 2 (i.e., pertinent to the clinical trial) will be described in this clinicaltrials.gov study description. Intervention and control patients will participate in: * Baseline assessment * Quarterly follow-up assessments * Monthly falls tracking Additionally, Intervention participants will receive: • An individualized medication action plan to deprescribe medications that put them at high risk for a fall Researchers will compare intervention and control participants for changes in self-reported fall rates (primary outcome), EMR-indicated medically-treated falls (secondary outcome), traffic-related charges (secondary outcome), and motor vehicle crashes (secondary outcome).
The "Safe Vehicle Engagement (SaVE)" trials are 3 parallel randomized clinical trials that aim to determine the impact of text messaging (SMS) vehicle safety interventions vs. weekly SMS vehicle safety self-monitoring alone on seat belt use, distracted driving and drink driving among young adults identified in the emergency department (ED) with risky vehicle behaviors.
This study is investigating whether changes in the shape and size of bodily muscles and spinal cord anatomy can influence recovery rates following a motor vehicle collision (MVC). The objective is to demonstrate that the presence of muscle and spinal cord degeneration and associated muscle weakness is the consequence of a mild MVC-related injury involving the cervical spinal cord.
This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents.
To determine the effectiveness of four group session of motivational counseling plus six hours of direct observations of the emergency department trauma services in comparison to four group session and six hours of community volunteering and also in comparison to four hours of education and 16 hours of community volunteering in reducing alcohol use and high risk driving behaviors and offenses among court referred 16-20 year old drivers.
The purpose of this study is to determine whether a walking school bus program can increase the number of children walking to school and decrease the number of children driven by car to school.
This study will evaluate the driving performance of new teenage drivers and determine to what extent independent driving experience improves driving performance of young drivers. Motor vehicle crash rates are highest among new teen drivers, especially during the first 6 months and 1,000 miles of independent licensed driving. Crash rates decline with experience, and this study will assess the effect of driving experience on performance. Newly licensed teenagers ranging from 16 years, 3 months to 17 years of age and experienced drivers 30 to 50 years of age may be eligible for this study. Candidates must be able to legally drive in the commonwealth of Virginia and have at least 20/40 correctable vision. Participants complete a questionnaire about their health and driving experience. They are then tested on a driving test track. Teens are tested within 3 weeks of obtaining their driver's license and before they have more than 100 miles of independent driving experience. They are tested a second time 6 to 12 months later and after they have more than 1,000 miles of driving experience. A group of experienced adult drivers are also tested to provide a comparison. The driving test is conducted on a smart road - a controlled, 2.2-mile two-lane research track at the Virginia Tech Transportation Institute. It is designed for safety, with restricted access, nothing for a vehicle to hit, carefully placed guardrails, and other safety features. The research vehicle is equipped with airbags, anti-lock brakes, and other safety equipment. It also has sensors and tiny video cameras to assess the behavior of the vehicle and the driver; this equipment does not interfere with the operation of the vehicle. An experimenter accompanies the driver and instructs him or her to perform routine driving skills, such as stopping, changing lanes and maintaining speed, as well as to other tasks such as inserting a CD into an entertainment console, having a conversation, and answering a cellular telephone call. The driver has an opportunity to practice the tasks before being tested. The driver's speed is limited to 35 mph or less during the experiment and the driver is required to wear seat belts and follow safe driving procedures. The experimenter is in the front passenger seat can stop the vehicle using a separate brake pedal.
Teens are at high risk for traffic violations and car crashes because of their young age, lack of driving experience, and exposure to high-risk driving conditions. The Checkpoints Program has used increased parental restrictions on teen driving through at least the first 4 months after their children obtain a driver's permit. The purpose of this study is to evaluate the efficacy of the Checkpoints Program. Approximately 400 teens in Michigan will participate in one of two study groups. One group will take standard driver education classes; the other group will take driver education classes that incorporate the Checkpoints Program. Teens and their parents will complete a written survey after completing the classes and a telephone survey after teens obtain a driver's permit. Teens will complete additional telephone surveys 1, 3, 6, and 12 months after obtaining a driver's permit. Researchers will use this information to study how parents manage teen driving practices, teen driving experiences (amount and conditions of), and high-risk teen driving behaviors.
This study is aimed at developing ways to prevent acute pain from becoming chronic pain--specifically, pain associated with whiplash-associated disorders (WADs) from motor vehicle accidents. Research on the development of chronic pain due to musculoskeletal injury suggests that a person's initial emotional reactions, particularly fear of reinjury and subsequent avoidance of activity, contribute significantly to chronic pain and persistent disability. This study will treat people with WADs during the first three months after a motor vehicle accident with a behavioral and physical exercise program designed to encourage activity and discourage continued fear of movement, pain, and disability. The study will compare the effectiveness of two anxiety-reduction treatments to standard care in reducing pain and activity limitations in people with WADs in the 2 to 3 months after motor vehicle accidents.