Distracted Driving App Study for Teens and Parents/Caregivers

Distracted Driving Clinical Trial

— IDD  

Official title:

An Informatics Approach to Preventing Distracted Driving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177524
• Other study ID #: 19-016717
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application

Description:

This 3-group randomized controlled trial aims to (1) evaluate the frequency of smartphone use among young drivers and their parents/caregivers while driving; and (2) determine if the LifeSaver mobile app reduces the rate of smartphone use while driving. Eligible participants will be licensed teenage drivers between the ages of 16 and 18 years, and a parent/caregiver. The app will be downloaded and installed on both parent/caregivers' and teens' phones to monitor phone use while in a vehicle for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Licensed teen drivers 16 years to 18 years and one parent/caregiver

• Teen and parent/caregiver are both Android smartphone users

• Teen and parent/caregiver both drive a minimum of 2 days per week

Exclusion Criteria:

• Non-fluency in written or spoken English

Related Conditions & MeSH terms

• Distracted Driving

Intervention

Device:
• Background Mode
The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.
• Manual Mode
In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.
• Auto-Detect Mode
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia Roberts Center for Pediatric Research	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Minnesota HealthSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of smartphone use while driving	Frequency of smartphone use is recorded by the LifeSaver app among the three app modes. Within-driver smartphone use over the 8-week study period is compared as the app modes change.	Week 2, 4, 6, and post-intervention at Week 8
Secondary	Change in frequency of self-reported smartphone use while driving	The change in self-reported smartphone use while driving will be assessed using the same within-driver and between-driver comparisons as the primary outcome measure. Self-reported smartphone use is collected through 10 items on a participant survey that is completed at enrollment, Weeks 2, 4, 6 and post-intervention at Week 8. Participants report how many days during the previous 2 weeks (0-14) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving. Participants also report how many times per day (free text, any number greater than or equal to 0) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving. There is no overall self-reported smartphone use score for these survey items.	Weeks 2, 4, 6, and Post-Intervention at Week 8
Secondary	Participant acceptability of the smartphone App: survey	Participant assessment of accessibility will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared. Participants complete a survey at Week 8, post-intervention. 8 items in the survey ask participants about accessibility of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about accessibility of the app through open-ended questions, where participants are able to enter free text. There is no overall score for these survey items.	Post-Intervention at Week 8
Secondary	Participant usability of the smartphone app: survey	Participant assessment of usability will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared. Participants complete a survey at Week 8, post-intervention. 8 items in the survey ask participants about usability of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about usability of the app through open-ended questions, where participants are able to enter free text. There is no overall score for these survey items.	Post-Intervention at Week 8