Clinical trial NCT05554614: Behind the Wheel (BTW) Smartphone Application
Official title: Behind the Wheel (BTW) Smartphone Application: Utilizing Technology to Quantify Driving Behaviors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High-risk Driving Events
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2022-09-26
Enrollment: 180
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to find out if a phone app can help the learning-to-drive process among teenagers and novice drivers.

Detailed description: This project will assess the feasibility and preliminary efficacy of an app (BTW) to quantify driving behaviors and promote safe driving in adolescents who are beginning their learner period of licensure. 90 teens and their corresponding parents/guardians will be randomized into one of three study groups. Researchers aim to test the feasibility of the BTW app on acceptance and retention, evaluate the preliminary efficacy of the BTW app with a teen-parent dyad intervention on driving performance after using the BTW app for six months, and investigate the long-term effects of the BTW app intervention on driving performance and safety attitudes among teens.

Eligibility criteria: Inclusion criteria:

* Teen participants must be between the ages of 15.5-17 years old at the time of enrollment
* Participants must have one parent and/or legal guardian who agrees to participate in the study.
* Participants' parents must possess car insurance with at least state-minimum coverage.
* Participants must be willing to fulfill the minimum requirements of the Ohio GDL system.
* Driver must complete a driver education class at a licensed driver training school with 24 hours of classroom or online instruction and 8 hours of driving time; driver must complete 50 hours of driving with at least 10 hours of night driving; driver must hold the permit for at least 6 months.
* Participants must have a functioning smartphone and active smartphone account compatible for the BTW app.
* To prevent any interference from another driving-related study, participants must agree not to enroll in other driving-related research/driving performance app during the study period.
* Participants must be willing to be randomized and comply with study requirements.
* Participants must speak and read English.
* Participants must be a US citizen or have permanent resident status.

Exclusion criteria:

- Drivers younger than 15.5 will be excluded because Ohio does not issue a temporary instruction driving permit identification card (i.e., learner's driving permit) starting the GDL process until age 15.5.

Primary outcomes:
measure: High-risk driving events
timeFrame: Baseline to 6 months post randomization
Secondary outcomes:
measure: Speeding and near-crash events
timeFrame: Baseline to 6 months post randomization
Other outcomes:
measure: Self-reported high risk driving behaviors
timeFrame: 18-month study period
measure: Self-reported driving safety attitudes
timeFrame: 18-month study period
measure: Self-reported traffic violations
timeFrame: 18-month study period
measure: Police-reported traffic violations
timeFrame: 18-month study period
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Motao Zhu, MD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: