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Preventing Distracted Driving Phase II

A Novel Distracted Driving Prevention Technology Phase II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05608018
Enrollment
500
Registered
2022-11-07
Start date
2023-06-26
Completion date
2024-07-23
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distracted Driving

Keywords

mobile phone use while driving

Brief summary

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.

Detailed description

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.

Interventions

OTHERIntervention Bluetooth

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

OTHERIntervention non-Bluetooth

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

OTHERControl Bluetooth

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

OTHERControl non-Bluetooth

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

Sponsors

Children's Hospital of Philadelphia
CollaboratorOTHER
Minnesota HealthSolutions
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants will be randomly assigned to the intervention/Bluetooth group, intervention/non-Bluetooth group, control/Bluetooth group, or control/non-Bluetooth group upon enrollment in the study. Assignment status will not be concealed from the research assistants enrolling the participant, the participants themselves, or the rest of the study team.

Intervention model description

This study is a randomized control trial with 2 arms, and 4 possible randomization groups (intervention/Bluetooth, intervention/non-Bluetooth, control/Bluetooth, and control/non-Bluetooth). The control group will receive the control condition, during which the app monitors driving but the intervention feature is not enabled, and the intervention group will receive the intervention condition during which the intervention feature is enabled. Both groups will self-report their smartphone communication while driving via periodic surveys. Participants randomized to receive a Bluetooth device will keep the device in their primary vehicle for the duration of the study. This device will collect outgoing text date and time from their dyad partner enrolled in the study. Non-Bluetooth participants will not receive the device.

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

Teen participants: 1. 16 to 19 years of age 2. Hold a valid driver's license 3. Own an iPhone 4. Drive at least 3 days per week Parent/caregiver participants: 1. 18 to 75 years of age 2. Hold a valid driver's license 3. Own an iPhone 4. Drive at least 3 days per week

Exclusion criteria

Teen participants: 1\. Non-fluency in written or spoken English Parent/caregiver participants: 1\. Non-fluency in written or spoken English

Design outcomes

Primary

MeasureTime frameDescription
Changes in frequency of smartphone use while driving3 weeksChanges 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

MeasureTime frameDescription
Changes in frequency of self-reported smartphone use while driving3 weeksThe 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.
Acceptability and Usability of the App3 weeksParticipant 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.
Changes in frequency of text messages sent to Bluetooth device users3 weeksBluetooth 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026