- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05608018
Preventing Distracted Driving Phase II
March 6, 2024 updated by: Minnesota HealthSolutions
A Novel Distracted Driving Prevention Technology 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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Morgan O'Donald, MPH
- Phone Number: 267-499-4114
- Email: odonaldm@chop.edu
Study Contact Backup
- Name: Lauren O'Malley, MPH
- Email: omalleyl2@chop.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- Morgan O'Donald, MPH
- Phone Number: 267-499-4114
- Email: odonaldm@chop.edu
-
Contact:
- Lauren O'Malley, MPH
- Email: omalleyl2@chop.edu
-
Principal Investigator:
- Allison Curry, PhD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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:
1. Non-fluency in written or spoken English
Parent/caregiver participants:
1. Non-fluency in written or spoken English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with some features turned off.
|
Other: 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.
|
Participants will receive a Bluetooth device to use for the duration of the study, and will use the app with all features turned on.
|
Other: 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.
|
Participants will not receive a Bluetooth device, and will use the app with some features turned off.
|
Other: 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.
|
Participants will not receive a Bluetooth device, and will use the app with all features turned on.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 weeks
|
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 weeks
|
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.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara Seifert, MPH, Study Principal Investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- National Highway Traffic Safety Administration. Research Note: Distracted Driving 2015. Washington, DC; 2017. https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812381.
- Ehsani J, Li K, Simons-Morton BG. Teenage Drivers Portable Electronic Device Use While Driving. In: ; 2015:219-225. doi:10.17077/drivingassessment.1575
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 7, 2022
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-018977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data and study documents will be shared with Minnesota HealthSolutions (the sponsor).
No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval.
The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
IPD Sharing Time Frame
The study will comply with CHOP's data retention policy (A-3-9).
All study data will be maintained for at least 6 years following study completion.
There is no set timeline for the destruction of the study's de-identified data
IPD Sharing Access Criteria
IRB approval, data use agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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