Distracted Driving App Study for Teens and Parents/Caregivers

Not Applicable

Completed

• Conditions: Distracted Driving
• Interventions: Device: Manual Mode; Device: Background Mode; Device: Auto-Detect Mode

• Registration Number: NCT04177524
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2020-01-23
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Manual Mode	Participants alternate between using the Manual Mode of the app for 2 weeks and Auto-Detect Mode of the app for 2 weeks, for a total of 4 periods (8 weeks).
Arm 3	Auto-Detect Mode	Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks.
Arm 2	Auto-Detect Mode	Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.
Arm 2	Manual Mode	Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.
Arm 3	Background Mode	Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks.
Arm 1	Auto-Detect Mode	Participants alternate between using the Manual Mode of the app for 2 weeks and Auto-Detect Mode of the app for 2 weeks, for a total of 4 periods (8 weeks).

Primary Outcome Measures

Name	Time	Method
Change in frequency of smartphone use while driving	Week 2, 4, 6, and post-intervention at Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Participant usability of the smartphone app: survey	Post-Intervention at Week 8	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.
Participant acceptability of the smartphone App: survey	Post-Intervention at Week 8	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.
Change in frequency of self-reported smartphone use while driving	Weeks 2, 4, 6, and Post-Intervention at Week 8	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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia Roberts Center for Pediatric Research; 🇺🇸 Philadelphia, Pennsylvania, United States