Clinical trial NCT05163119: Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use
Official title: Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cell Phone Use
Automobile Driving
Keywords: Texting
Driving
Mobile Technology
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Ohio State University
name: University of Iowa
First posted: 2021-12-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Calling, texting, and handheld cell phone use while driving
timeFrame: 5-month intervention period
measure: High-risk driving events
timeFrame: 5-month intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Abigail Wexner Research Institute at Nationwide Children's Hospital
name: Motao Zhu
role: PRINCIPAL_INVESTIGATOR
References: