Treatment Trials

18 Clinical Trials for Various Conditions

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RECRUITING
Washington State Driving Intervention Research Study
Description

The goal of this clinical trial is to test the effect of hazard perception and attention maintenance training and testing on driving performance. Participants will be randomized into a treatment group receiving hazard perception or attention maintenance training or a control group receiving either vehicle maintenance training or the status quo ZED training. Randomization will occur by location. Researchers will compare the treatment and control groups to see if there are differences in driving behavior and crash rates.

COMPLETED
Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim
Description

Subjects will participate in a 4-visit study protocol at the National Advanced Driving Simulator, part of the University of Iowa, in which they will be asked to complete assorted questionnaires, computerized cognitive tasks, and a simulator drive. Subjects will be administered 0.75 mg alprazolam (Xanax) or placebo and 500 mg vaporized cannabis (6.18% THC / \<0.025% CBD) or placebo (0% THC / 0% CBD). The primary objective of this study is to validate the Drug Impaired Driving Scenario (DIDS) using the CRCDS-2 driving simulator by assessing the acute effects of cannabis relative to placebo on simulated driving performance. Assay sensitivity will be demonstrated by the significant effect of 0.75 mg alprazolam (active comparator) on driving and cognitive endpoints.

COMPLETED
Opiates and Benzodiazepines on Driving
Description

The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies. This study continues a line of research designed to characterize the effects of common recreationally used prescription and illicit drugs with well known stimulant and sedating effects and their relationship to results from the Alertness Memory Profiler (AMP) that included a set of vigilance and memory tasks.

COMPLETED
Increasing Seat Belt Wearing and Decreasing Handheld Phone Use While Driving
Description

The study team is proposing to conduct a randomized controlled trial to determine the effectiveness of behavioral and financial incentives on phone use while driving and seat belt adherence. Each arm will receive a support text if their app is not collecting data. The behavioral engagement intervention includes persuasive education, mental contrasting with implementation intentions, customized habit tips, weekly feedback about participants' streaks, and encouraging SMS texts. The two financial incentive interventions add on weekly raffles or shared pots for participants with perfect streaks.

COMPLETED
Way To Drive Validation Study
Description

Way to Drive is a smart phone-based driving telematics application. Research participants are invited to download the app, which uses phone sensors to track driving behaviors including mileage, hard breaking events, and handheld phone use while driving, measured as the phone screen being unlocked while the phone is in the hand and the vehicle is in motion. Before the study team launches a clinical trial using the app, the researchers will test its capabilities and reliability.

COMPLETED
Teenage Passenger Influences on Driving Performance of Teenage Drivers
Description

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.

COMPLETED
Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents
Description

The purpose of this study is to measure the effects of an interactive video on adolescent risky behaviors and outcomes, with one video intended to reduce teen pregnancies and the other intended to reduce automobile accidents.

COMPLETED
Behavior and Driving Safety Study II
Description

The purpose of this study is to determine whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (DUI).

COMPLETED
Behavior and Driving Safety Study
Description

The purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI).

COMPLETED
Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders
Description

The purpose of this study is to determine whether Vivitrol is effective at reducing attempts to drive after drinking among repeat driving while intoxicated (DWI) offenders with Ignition Interlock devices.

COMPLETED
Translation Study of a Safe Teen Driving Intervention
Description

Steering Teens Safe (STS) is an evidence-based and parent-focused intervention developed by the investigators, which aims to improve safe teen driving practices by enhancing parental communication skills. The objective of this translation study is to assess the effect of STS on driving outcomes among teen drivers who have committed a traffic violation, and to assess the adoption and implementation fidelity of STS in a county court setting and among these high-risk teen drivers and their parents. The investigators will test the following specific aims: Aim 1: Determine the effects of the intervention on parent-teen communications and risky driving outcomes (risky driving events, unsafe driving behaviors, and recidivism) among teen drivers with a traffic violation(s). Aim 2: Assess the adoption of the intervention and implementation fidelity We will enroll 90 parent-teen dyads, comprised a teen driver (16 to 17 years) who committed a moving violation and a parent/legal guardian, from the Ohio Franklin County Juvenile Traffic Court following the teens' mandatory court hearing. Enrolled dyads will be randomly assigned to 1 of 2 study groups (n=45/group): 1) Control, device installation only with no feedback to nor communication training for parents, or 2) Intervention, device feedback to teens and parents, and parents will also receive individualized virtual communication training. The expected outcome is to establish the effectiveness of STS augmented with driving feedback technology, and to establish the implementation fidelity of STS in a court setting.

COMPLETED
Sensory Stimulation During Simulated Driving
Description

The purpose of this study is to examine the effect of three specific odors on simulated driving performance. It is hypothesized that the presence of peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions

Conditions
COMPLETED
Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving
Description

This project aims to demonstrate the feasibility of a scalable behavioral intervention using smartphone-paired breathalyzers and text message aimed at reducing drinking and driving among individuals who report heavy drinking. All participants receive a smartphone breathalyzer to provide feedback on their estimated blood alcohol level. The intervention compares loss- and gain-framed messages that make the consequences of drinking and driving more salient to standard messages not to drink and drive.

RECRUITING
Driver Education Research Study
Description

This study will test the effectiveness of different types of driver training interventions for reducing young new driver crash risk early after licensure.

COMPLETED
Cannabis Impairment Detection Application (CIDA)
Description

Subjects will participate in a 4-visit study protocol in which they will be asked to complete a set of computerized tasks and a 45-minute simulated drive in a driving simulator. Subjects will be administered marijuana of varying pre-determined concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) during 3 of the visits and alcohol during one of the visits. Throughout the duration of each visit, brain activity will be measured noninvasively using an electroencephalogram (EEG) headset. The purpose of this study is to: 1. Further understand the effects of acute cannabis intoxication on driving performance in a driving simulator 2. Develop and refine brain-based biomarkers of impairment due to acute cannabis intoxication

COMPLETED
The P4 Intervention Study to Improve Adolescent Health
Description

The primary objective is to conduct a pilot study to determine the efficacy of evidence-based interventions delivered in primary care clinic settings on parent-teen health communication.

COMPLETED
Evaluating Perceived Fitness to Drive While Intoxicated
Description

The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged \> 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.

COMPLETED
A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
Description

There is clear, converging evidence from multiple prospective studies with well-diagnosed adolescents with ADHD and comparison, non-ADHD adolescents, that teen drivers with ADHD have more accidents and other adverse driving outcomes. Available research indicates parental monitoring and limit-setting for adolescent drivers is one of the most effective interventions for preventing negative driving outcomes. For children with ADHD, interventions to promote parenting capacity to effectively oversee and intervene in teen driving will likely need to be intensive and require multiple treatment components. The present proposal aims to compare the standard care for teen drivers (driver's education classes and driving practice) to the Supporting a Teen's Effective Entry to the Roadway (STEER) program, that includes a parent-teen intervention, adolescent skill building, parent training on effective adolescent management strategies, joint parent-teen negotiations sessions, practice on a driving simulator, parental monitoring of objective driving behaviors, and the targeting of safe teen driving via contingency management strategies (i.e., parent-teen contracts). To facilitate teen and parent engagement the intervention will be preceded by a motivational interview. The specific aims of the proposal are to investigate the efficacy of the STEER program relative to a standard care group in a randomized clinical trial (N=172) on measures of objective driving outcome and parenting capacity. It is hypothesized that the STEER program will result in improved outcomes relative to the standard care group at the end of intervention and 6 and 12 month follow-up assessments.