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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06146634
Other study ID # IRB00025991
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2, 2024
Est. completion date February 2027

Study information

Verified date June 2024
Source Johns Hopkins Bloomberg School of Public Health
Contact Johnathon Ehsani, PhD
Phone 410-614-2797
Email jpehsani@jhu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The experiment's purpose is to assess the performance of the investigator's novel Driving Hazard Perception and Attention Maintenance training intervention on improving related driving skills, performance in driving exams, and long-term benefits as assessed by crash statistics and naturalistic driving behavior. A two-group pre-post experimental design will be used to evaluate the effectiveness of the new Driving Hazard Perception Training. Each training (hazard perception and attention maintenance) will be assessed in relation to the status quo (ZED training) and in relation to a placebo that has no training related to hazard perception or attention maintenance (vehicle maintenance training). Participants beginning a driver education program will be recruited. Each participating location will be randomized to one of the four research arms. Baseline hazard perception assessment will be performed first, and then participants will receive one of the four trainings. Lastly, all participants will take a hazard perception exam to assess the participants' performance. All participants will also use a smartphone application to collect driving data during the learner driver period and 12 months of independent driving. Driving behaviors and state-level crash data will be used to assess the impact of the interventions.


Recruitment information / eligibility

Status Recruiting
Enrollment 8000
Est. completion date February 2027
Est. primary completion date February 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - Enrollment in a driver training course through the 911 driving school in Washington State. Exclusion Criteria: - Participants must meet the above criteria. - Additionally, participants will be excluded if either the participant or the participant's parent opts-out.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Hazard Perception Training
The hazard perception training is comprised of three modules. Each module is comprised of four scenarios. Each hazard perception scenario has two activities. The entire training is expected to take approximately an hour to complete.
Vehicle Maintenance Training
For participants randomized into the placebo group, they will receive a brief training on vehicle maintenance using a series of short videos. These videos describe regular checks that drivers should do, such as checking windshield wiper fluid levels, and how to change engine oil. Altogether the videos will last approximately 1 hour.
Attention Maintenance Training
The attention maintenance training is comprised of three modules. Each module is comprised of four scenarios, with each scenario corresponding to one activity. The entire training is expected to take approximately an hour to complete.

Locations

Country Name City State
United States The Driver Training Group Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health National Academy of Sciences, The Driver Training Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Crashes The number of participant-involved crashes. Post-licensure up to 12 months
Primary Number of Near-crashes The number of participant-involved near-crashes. Post-licensure up to 12 months
Primary Longitudinal g-force events Significant longitudinal g-force events greater than 0.5 g Post-licensure up to 12 months
Primary Lateral g-force events Significant lateral g-force events greater than 0.5 g Post-licensure up to 12 months
See also
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