Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use

Automobile Driving Clinical Trial

Official title:

Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163119
• Other study ID #: STUDY00001601
• Secondary ID: R01HD102439
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Nationwide Children's Hospital
• Contact: Motao Zhu, MD,MS,PhD
• Phone: (614)-355-6687
• Email: motao.zhu[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention on driving behavior in drivers aged 18-24 years.

Description:

For this study, 1200 teens aged 18-24 years will be randomized into one of three study groups for 6 months. Researchers aim to evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on cellphone use while driving and evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on high-risk driving events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Adults 18-24 years of age at time of recruitment

• Must have ownership and exclusive access to a passenger vehicle

• Must have car insurance with at least state-minimum coverage

• Must live in Greater Columbus (Ohio) area

• Must drive at least 2 days a week on average

• Must have functioning iPhone or Android smartphone with an active phone service account (Ex: Verizon, AT&T, etc.)

• Must self-report handheld calling or texting while driving (= 1 time/week)

• Must not be enrolled in another driving-related research study during the study period.

• Must be willing to be randomized and comply with study requirements

• Must have no plans to change cellphones or vehicles in next 6 months or agree to transfer FleetSafer app/DriveCam if they change cellphones or vehicles

• Must speak and read English

Exclusion Criteria:

• Drivers under 18 years of age

• Drivers holding learner's permits

• Drivers who share a vehicle with a family member or others

• Infrequent drivers (Drive 2 days a week or less)

• Participants from the pilot R21 project

• Current users of a cellphone-blocking app or driving mode who do not agree to uninstall/de-activate the app for the duration of participation in the study

• Current users of a car insurance monitoring device (physical device or app)

Related Conditions & MeSH terms

• Automobile Driving
• Cell Phone Use

Intervention

Behavioral:
• Commercial Cellphone-Blocking App (Active)
The Fleetsafer app, which is a commercial cellphone app that uses a cellphone's standard sensors and function to block handheld cellphone use while driving, will be downloaded on the participant's smartphone.
• Driving Mode
Apple's "Do Not Disturb" driving mode provided by Apple for iPhones or Google Do Not Disturb, Verizon Messages +, Android Auto or have another app, called LifeSaver installed on their Android phone (collectively referred to as driving modes; the specific driving mode for participants in this arm will be determined based on smartphone type and service provider).

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Motao Zhu	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ohio State University, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calling, texting, and handheld cell phone use while driving	Number of calling occurrences, texting occurrences, and handheld phone use occurrences, per 1,000 miles driven. Higher numbers signify more calling, texting, and handheld cell phone use.	5-month intervention period
Primary	High-risk driving events	Total number of high-risk driving events (e.g., hard-braking, sudden acceleration, swerving) per 1,000 miles driven. Higher numbers signify more high-risk driving events.	5-month intervention period