Preventing Distracted Driving Phase II

NCT ID: NCT05608018

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2024-07-23

Brief Summary

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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

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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.

Conditions

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Distracted Driving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Control Bluetooth

Participants receive a the same app as the intervention group, but the feature that notifies the teens parent when they are driving is turned off. They will self-report their smartphone communication while driving via periodic surveys. Participants will receive a Bluetooth device to keep in their primary vehicle for the duration of the study.

Group Type OTHER

Control Bluetooth

Intervention Type 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.

Intervention Bluetooth

Participant received the app with all features turned on, so the parent gets a notification when the teen is driving before they go to send a text message to the teen. They will self-report their smartphone communication while driving via periodic surveys. Participants will receive a Bluetooth device to keep in their primary vehicle for the duration of the study.

Group Type OTHER

Intervention Bluetooth

Intervention Type 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.

Control non-Bluetooth

Participants receive a the same app as the intervention group, but the feature that notifies the teens parent when they are driving is turned off. They will self-report their smartphone communication while driving via periodic surveys. Participants will not receive a Bluetooth device.

Group Type OTHER

Control non-Bluetooth

Intervention Type OTHER

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

Intervention non-Bluetooth

Participant received the app with all features turned on, so the parent gets a notification when the teen is driving before they go to send a text message to the teen. They will self-report their smartphone communication while driving via periodic surveys. Participants will not receive a Bluetooth device.

Group Type OTHER

Intervention non-Bluetooth

Intervention Type OTHER

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

Interventions

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Intervention 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.

Intervention Type OTHER

Intervention non-Bluetooth

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

Intervention Type OTHER

Control 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.

Intervention Type OTHER

Control non-Bluetooth

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Minnesota HealthSolutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Seifert, MPH

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Durbin DR, Curry AE, García-España JF, et al. Miles to Go: Monitoring Progress in Teen Driver Safety. The Children's Hospital of Philadelphia Research Institute and State Farm Insurance Companies; 2012. http://www.teendriversource.org/tools/support_gov/detail/205.

Reference Type BACKGROUND

Curry AE, Hafetz J, Kallan MJ, Winston FK, Durbin DR. Prevalence of teen driver errors leading to serious motor vehicle crashes. Accid Anal Prev. 2011 Jul;43(4):1285-90. doi: 10.1016/j.aap.2010.10.019. Epub 2010 Nov 19.

Reference Type BACKGROUND
PMID: 21545856 (View on PubMed)

Redelmeier DA, Tibshirani RJ. Association between cellular-telephone calls and motor vehicle collisions. N Engl J Med. 1997 Feb 13;336(7):453-8. doi: 10.1056/NEJM199702133360701.

Reference Type BACKGROUND
PMID: 9017937 (View on PubMed)

National Highway Traffic Safety Administration. Research Note: Distracted Driving 2015. Washington, DC; 2017. https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812381.

Reference Type BACKGROUND

Ehsani J, Li K, Simons-Morton BG. Teenage Drivers Portable Electronic Device Use While Driving. In: ; 2015:219-225. doi:10.17077/drivingassessment.1575

Reference Type BACKGROUND

Insurance Institute for Highway Safety, Highway Loss Data Institute. Fatality Facts 2017: Teenagers. Insurance Institute for Highway Safety (IIHS). https://www.iihs.org/topics/fatality-statistics/detail/teenagers. Published 2018. Accessed August 12, 2019.

Reference Type BACKGROUND

How Teens Use Media: A Nielsen Report on the Myths and Realities of Teen Media Trends.; 2009. http://blog.nielsen.com/nielsenwire/reports/nielsen_howteensusemedia_june09.pdf.

Reference Type BACKGROUND

Pradhan AK, Hammel KR, DeRamus R, Pollatsek A, Noyce DA, Fisher DL. Using eye movements to evaluate effects of driver age on risk perception in a driving simulator. Hum Factors. 2005 Winter;47(4):840-52. doi: 10.1518/001872005775570961.

Reference Type BACKGROUND
PMID: 16553070 (View on PubMed)

Hafetz JS, Jacobsohn LS, Garcia-Espana JF, Curry AE, Winston FK. Adolescent drivers' perceptions of the advantages and disadvantages of abstention from in-vehicle cell phone use. Accid Anal Prev. 2010 Nov;42(6):1570-6. doi: 10.1016/j.aap.2010.03.015. Epub 2010 Jul 2.

Reference Type BACKGROUND
PMID: 20728605 (View on PubMed)

LaVoie N, Lee YC, Parker J. Preliminary research developing a theory of cell phone distraction and social relationships. Accid Anal Prev. 2016 Jan;86:155-60. doi: 10.1016/j.aap.2015.10.023. Epub 2015 Nov 10.

Reference Type BACKGROUND
PMID: 26562672 (View on PubMed)

McDonald CC, Sommers MS. Teen Drivers' Perceptions of Inattention and Cell Phone Use While Driving. Traffic Inj Prev. 2015;16 Suppl 2(0):S52-8. doi: 10.1080/15389588.2015.1062886.

Reference Type BACKGROUND
PMID: 26436243 (View on PubMed)

Other Identifiers

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21-018977

Identifier Type: -

Identifier Source: org_study_id

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