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OpenTrials
Completed

NCT Number: NCT05608018

Preventing Distracted Driving Phase II

The purpose of the study is to determine the efficacy of a smartphone app in reducing mobile phone use while driving among teens and parents. Prior to sending a message, the smartphone app informs a potential message sender that the recipient is driving.

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Key information

Conditions

Distracted Driving

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

The primary objective of this study is to determine whether the app reduces (1) smartphone communication sent from parent to teen while the teen is driving; and (2) smartphone communication sent from teen while the teen is driving. The secondary objectives are to: Determine whether the app reduces smartphone communication sent from teen to parent while parent is driving; Evaluate the acceptability of the app among parents and teens; and determine the relationship between individual differences (demographics, typical smartphone use, driving history, risk perception) and the app's efficacy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Teen participants:

  • 16 to 19 years of age
  • Hold a valid driver's license
  • Own an iPhone
  • Drive at least 3 days per week

Parent/caregiver participants:

  • 18 to 75 years of age
  • Hold a valid driver's license
  • Own an iPhone
  • Drive at least 3 days per week

Exclusion criteria

Teen participants:

  • Non-fluency in written or spoken English

Parent/caregiver participants:

  • Non-fluency in written or spoken English

Treatment and study plan

Intervention Bluetooth

Other

Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with all features turned on.

Intervention non-Bluetooth

Other

Participants will not receive a Bluetooth device, and will use the app with all features turned on.

Control Bluetooth

Other

Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with some features turned off.

Control non-Bluetooth

Other

Participants will not receive a Bluetooth device, and will use the app with some features turned off.

Primary outcomes

  1. Changes in frequency of smartphone use while driving

    Time frame: 3 weeks

    Changes in smartphone communication sent from parent to teen while the teen is driving and changes in smartphone communication sent from teen while the teen is driving. Frequency of smartphone use is recorded by the app among the three app modes. Within-driver smartphone use over the 3-week study period is compared as the app modes change. Smartphone use between driver groups will also be compared.

Secondary outcomes

  1. Changes in frequency of self-reported smartphone use while driving

    Time frame: 3 weeks

    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, each week for 3 weeks. 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, sent a text, and read a text while driving.

  2. Acceptability and Usability of the App

    Time frame: 3 weeks

    Participant assessment of accessibility and usability will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared. Participants complete a survey at the end of week 3, post-intervention. 8 items in the survey ask participants about accessibility and usability of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about accessibility and 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.

  3. Changes in frequency of text messages sent to Bluetooth device users

    Time frame: 3 weeks

    Bluetooth device users will have received text message date and time collected via the Bluetooth device. This device will only collect data from the dyad partner enrolled in the study with them. This data will be used to validate the self report data collected from all participants.

Sponsors and collaborators

Lead sponsor

Minnesota HealthSolutions

Industry

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

A Novel Distracted Driving Prevention Technology Phase II

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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