Behind the Wheel (BTW) Smartphone Application (BTW)

Behind the Wheel (BTW) Smartphone Application: Utilizing Technology to Quantify Driving Behaviors

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.

Study Overview

• Status: Recruiting
• Conditions: High-risk Driving Events
• Intervention / Treatment: Behavioral: BTW app with reward-based feedback; Behavioral: BTW app with situational supervised driving practice; Behavioral: Sham BTW app

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Motao Zhu, MD, MS, PhD; Phone Number: (614)-355-6687; Email: motao.zhu@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Motao Zhu, MD, MS, PhD; Phone Number: 614-355-6687; Email: motao.zhu@nationwidechildrens.org
      • Principal Investigator: Motao Zhu, MD, MS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BTW app with reward-based feedback; Teens will install the BTW app with reward-based feedback. This tracks driving performance while providing individualized driving feedback using gamification concepts.	Behavioral: BTW app with reward-based feedback; Teen drivers will be notified of their weekly driving performance via a driving safety score with information on the types of high-risk driving behaviors committed as well as progress on maintaining and/or improving weekly safe driving behaviors. Educational materials on different driving situations and scenarios associated with the high-risk driving behaviors (e.g. 90-second videos) will be provided for the driver to review at any point and time. Information on these driving behaviors and the education material will be provided via push notifications from the BTW app. Weekly leader boards will show the driver's driving safety score in comparison to other drivers of the same age. Consistently high driver safety scores in certain driving skill areas (e.g., cornering) and a total overall score above 70% of other users on that skill or total score will unlock gamification-based rewards (e.g., driving safety badges, driving safety score leader board, group challenges with winners).; Behavioral: BTW app with situational supervised driving practice; Teen drivers will be provided bi-weekly push-notifications from the BTW app notifying them of situational supervised driving practice activities that are to be completed during the assigned week. There are 12 situational supervised driving activities and six skill-building driving activities (Table 1). Skill-building sessions are assigned for off weeks during the first half of the six months (weeks 2-12), allowing for skills to be further developed when the situations are encountered for a second time (weeks 15-23). Parents will be prompted to directly log situational supervised and skill-building driving activities in the app after the session within the BTW app to obtain the module completion date and duration time.
Experimental: BTW app with situational supervised driving practice; Teens will install the BTW app the same as the app with reward-based feedback in conjunction with a situational supervised driving practice intervention for teen-parent dyads.	Behavioral: BTW app with situational supervised driving practice; Teen drivers will be provided bi-weekly push-notifications from the BTW app notifying them of situational supervised driving practice activities that are to be completed during the assigned week. There are 12 situational supervised driving activities and six skill-building driving activities (Table 1). Skill-building sessions are assigned for off weeks during the first half of the six months (weeks 2-12), allowing for skills to be further developed when the situations are encountered for a second time (weeks 15-23). Parents will be prompted to directly log situational supervised and skill-building driving activities in the app after the session within the BTW app to obtain the module completion date and duration time.
Sham Comparator: Sham BTW app; Teens will install the sham BTW app with driving performance tracking only.	Behavioral: Sham BTW app; Teens will be provided links to passive education materials and information on car maintenance every week. They will not be given feedback on their driving performances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-risk driving events	Number of high-risk driving events (harsh breaking, accelerating, and cornering events) per 1,000 miles driven. Higher numbers signify more high-risk driving events.	Baseline to 6 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speeding and near-crash events	Instances of speeding and number of near crashes and crashes per 1,000 miles driven. Higher numbers signify more near-crash events.	Baseline to 6 months post randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported high risk driving behaviors	Self-reported frequency of high risk driving behaviors including speeding, distracted driving and driving under the influence of alcohol or drugs.	18-month study period
Self-reported driving safety attitudes	The distribution of attitudes towards traffic safety behaviors, including speeding, distracted driving, and driving under the influence of alcohol or drugs, measured through self-report on 4-point Likert scales.	18-month study period
Self-reported traffic violations	The number of traffic violations, including speeding, intoxicated driving, and distracted driving, measured through self-report on a questionnaire.	18-month study period
Police-reported traffic violations	Number of police-reported crashes and traffic violations. Higher numbers signify more crashes and violations.	18-month study period

Collaborators and Investigators

• Sponsor: Motao Zhu
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Motao Zhu, MD, MS, PhD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002565; FP00001219 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No