High-risk Driving EventsBTWNCT05554614
Behind the Wheel (BTW) Smartphone Application
A study testing BTW app with reward-based feedback and BTW app with situational supervised driving practice in people with High-risk Driving Events, run by Motao Zhu at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- High-risk Driving Events
- What is being tested?
- BTW app with reward-based feedback and BTW app with situational supervised driving practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2023to 23 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
Read the 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.
- Conditions
- High-risk Driving Events
- Being tested
- BTW app with reward-based feedback, BTW app with situational supervised driving practice, Sham BTW app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTW app with reward-based feedbackBehavioural
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).
BTW app with situational supervised driving practiceBehavioural
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 BTW appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BTW app with reward-based feedback | Experimental | Teens will install the BTW app with reward-based feedback. This tracks driving performance while providing individualized driving feedback using gamification concepts. Receives: Behavioral: BTW app with reward-based feedback; Behavioral: BTW app with situational supervised driving practice |
| BTW app with situational supervised driving practice | Experimental | 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. Receives: Behavioral: BTW app with situational supervised driving practice |
| Sham BTW app | Sham comparator | Teens will install the sham BTW app with driving performance tracking only. Receives: Behavioral: Sham BTW app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months post randomization
Secondary outcomes (1)
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.
Measured: Baseline to 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start19 Feb 2023
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Driving EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Motao Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Motao Zhu, Nationwide Children's Hospital
- Investigators
- Motao Zhu, MD, MS, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554614
- Sponsor's protocol ID
- STUDY00002565
- Other IDs
- FP00001219
- Acronym
- BTW
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behind the Wheel (BTW) Smartphone Application: Utilizing Technology to Quantify Driving Behaviors
- ClinicalTrials.gov ID
- NCT05554614
- Acronym / sponsor ID
- BTW / STUDY00002565
- Conditions
- High-risk Driving Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Motao ZhuUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 19 Feb 2023 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BTW app with reward-based feedback | Experimental | Behavioral: BTW app with reward-based feedback, Behavioral: BTW app with situational supervised driving practiceTeens will install the BTW app with reward-based feedback. This tracks driving performance while providing individualized driving feedback using gamification concepts. |
| BTW app with situational supervised driving practice | Experimental | Behavioral: BTW app with situational supervised driving practiceTeens 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. |
| Sham BTW app | Sham comparator | Behavioral: Sham BTW appTeens will install the sham BTW app with driving performance tracking only. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTW app with reward-based feedbackTeen 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). | Behavioural | BTW app with reward-based feedback |
| BTW app with situational supervised driving practiceTeen 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. | Behavioural | BTW app with reward-based feedback, BTW app with situational supervised driving practice |
| Sham BTW appTeens 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. | Behavioural | Sham BTW app |
Primary outcome
High-risk driving events
Time frame: Baseline to 6 months post randomization
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.
1 secondary outcome
Speeding and near-crash events
Time frame: Baseline to 6 months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Motao Zhu, MD, MS, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTW app with reward-based feedback and BTW app with situational supervised driving practice in people with High-risk Driving Events, run by Motao Zhu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-risk driving events (time frame: Baseline to 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.