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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04317664
Other study ID # 1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 28, 2020
Est. completion date October 15, 2025

Study information

Verified date February 2024
Source Nationwide Children's Hospital
Contact Jingzhen (Ginger) Yang, PhD, MPH
Phone 614-355-5852
Email ginger.yang@nationwidechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the effects of an in-vehicle driving feedback technology, with and without parent communication training, on risky driving events, unsafe driving behaviors, and subsequent traffic violations among teens who have recently received a moving traffic violation.


Description:

For this study, 240 teen and parent/guardian dyads will be randomized into one of three study groups for six months. Teens will be aged 16-17 who committed a moving-related traffic violation and their parent/legal guardian who is most involved with their driving. Researchers will aim to determine the effects of the intervention on teens' risky driving events, unsafe driving behaviors, and traffic violation recidivism. Additionally, researchers will aim to determine the effects of the intervention on frequency and quality of parent-teen communications about safe driving practices.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date October 15, 2025
Est. primary completion date April 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 17 Years
Eligibility Inclusion Criteria: - Age 16-17 years at time of violation - Convicted of a moving violation - Possess a valid intermediate driver's license issued by the state of Ohio, with proof of car insurance - Access to a vehicle with an On-board Diagnostics II system port (i.e. cars made after 1996) in which he/she is the primary driver - Smartphone with Bluetooth capabilities - At least one legal guardian Exclusion Criteria: - Unable to drive due to injury, license suspension, or car damage - Vehicle already has an in-vehicle driving feedback system installed - Extremely low average weekly drive time (e.g. <1 hour per week) - Currently enrolled in another driving-related study - War of the State - Non-English speaking parent - Adults unable to consent - Pregnant women - Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
In-vehicle device
The Azuga™ in-vehicle driving feedback technology, which consists of a pager-sized device plugged into the vehicle's on-board diagnostic port (installed in the teen's car) and a smartphone app (downloaded on the teen's smartphone), will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Detailed cumulative driving data; and 3) A customized biweekly driving summary report.
Behavioral:
Parent Communication
An individualized virtual training in communication strategies about driving safety along with a booster session will be delivered by a traffic safety communication specialist to subjects in the Feedback and Parent Communication Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (4)

Lead Sponsor Collaborator
Ginger Yang Ohio State University, University of Iowa, University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (21)

Alver Y, Demirel MC, Mutlu MM. Interaction between socio-demographic characteristics: traffic rule violations and traffic crash history for young drivers. Accid Anal Prev. 2014 Nov;72:95-104. doi: 10.1016/j.aap.2014.06.015. Epub 2014 Jul 12. — View Citation

Ayuso M, Guillen M, Alcaniz M. The impact of traffic violations on the estimated cost of traffic accidents with victims. Accid Anal Prev. 2010 Mar;42(2):709-17. doi: 10.1016/j.aap.2009.10.020. Epub 2009 Nov 22. — View Citation

Carney C, McGehee DV, Lee JD, Reyes ML, Raby M. Using an event-triggered video intervention system to expand the supervised learning of newly licensed adolescent drivers. Am J Public Health. 2010 Jun;100(6):1101-6. doi: 10.2105/AJPH.2009.165829. Epub 2010 Apr 15. — View Citation

Centers for Disease Control and Prevention. Data and Statistics (WISQARS). www.cdc.gov/injury/wisqars. Accessed February 1, 2016.

Chen W, Cooper P, and Pinili M. Driver accident risk in relation to the penalty point system in British Columbia. J Safety Res. 1995;26:9-18.

Cooper PJ. The relationship between speeding behaviour (as measured by violation convictions) and crash involvement. J Safety Res. 1997;28:83-95.

Curry AE, Peek-Asa C, Hamann CJ, Mirman JH. Effectiveness of Parent-Focused Interventions to Increase Teen Driver Safety: A Critical Review. J Adolesc Health. 2015 Jul;57(1 Suppl):S6-14. doi: 10.1016/j.jadohealth.2015.01.003. — View Citation

Factor R. The effect of traffic tickets on road traffic crashes. Accid Anal Prev. 2014 Mar;64:86-91. doi: 10.1016/j.aap.2013.11.010. Epub 2013 Dec 2. — View Citation

Farah H, Musicant O, Shimshoni Y, Toledo T, Grimberg E, Omer H, Lotan T. Can providing feedback on driving behavior and training on parental vigilant care affect male teen drivers and their parents? Accid Anal Prev. 2014 Aug;69:62-70. doi: 10.1016/j.aap.2013.11.005. Epub 2013 Nov 27. — View Citation

Farmer CM, Kirley BB, McCartt AT. Effects of in-vehicle monitoring on the driving behavior of teenagers. J Safety Res. 2010 Feb;41(1):39-45. doi: 10.1016/j.jsr.2009.12.002. Epub 2010 Jan 29. — View Citation

Gebers MA, Peck RC. Using traffic conviction correlates to identify high accident-risk drivers. Accid Anal Prev. 2003 Nov;35(6):903-12. doi: 10.1016/s0001-4575(02)00098-2. — View Citation

Goldenbeld C, Reurings M, Van Norden Y, Stipdonk H. Crash involvement of motor vehicles in relationship to the number and severity of traffic offenses. An exploratory analysis of Dutch traffic offenses and crash data. Traffic Inj Prev. 2013;14(6):584-91. doi: 10.1080/15389588.2012.743125. — View Citation

Insurance Institute for Highway Safety (IIHS). Fatality facts: teenagers 2013. Arlington, VA: http://www.iihs.org/iihs/topics/t/teenagers/fatalityfacts/teenagers. Accessed February 1, 2016.

Jonah BA, and Dawson NE. Youth and risk: age differences in risky driving, risk perception, and risk utility. Alcohol, Drugs and Driving. 1987;3(3):13-29.

Mayhew DR, Simpson HM, Pak A. Changes in collision rates among novice drivers during the first months of driving. Accid Anal Prev. 2003 Sep;35(5):683-91. doi: 10.1016/s0001-4575(02)00047-7. — View Citation

McCartt AT, Farmer CM, Jenness JW. Perceptions and experiences of participants in a study of in-vehicle monitoring of teenage drivers. Traffic Inj Prev. 2010 Aug;11(4):361-70. doi: 10.1080/15389588.2010.486428. — View Citation

McCartt AT, Shabanova VI, Leaf WA. Driving experience, crashes and traffic citations of teenage beginning drivers. Accid Anal Prev. 2003 May;35(3):311-20. doi: 10.1016/s0001-4575(02)00006-4. — View Citation

McGehee DV, Raby M, Carney C, Lee JD, Reyes ML. Extending parental mentoring using an event-triggered video intervention in rural teen drivers. J Safety Res. 2007;38(2):215-27. doi: 10.1016/j.jsr.2007.02.009. Epub 2007 Mar 28. — View Citation

Rajalin S. The connection between risky driving and involvement in fatal accidents. Accid Anal Prev. 1994 Oct;26(5):555-62. doi: 10.1016/0001-4575(94)90017-5. — View Citation

Summala H, Rajalin S, Radun I. Risky driving and recorded driving offences: a 24-year follow-up study. Accid Anal Prev. 2014 Dec;73:27-33. doi: 10.1016/j.aap.2014.08.008. Epub 2014 Aug 27. — View Citation

Williams AF. Teenage drivers: patterns of risk. J Safety Res. 2003 Jan;34(1):5-15. doi: 10.1016/s0022-4375(02)00075-0. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Engagement with Parent Communication Training Engagement with the parent communication training will be measured among parents in the Feedback and Parent Communication Group using online measurements. Six months/study period
Other Engagement with Device Feedback Engagement with device feedback will be measured among teens in the Feedback Only Group and the Feedback and Parent Communication Group and parents in the Feedback and Parent Communication Group via online tracking of the participant's web interface using Google Analytics. Six months/study period
Primary Number of Risky Driving Events Events of hard braking and sudden acceleration. Six months/study period
Primary Number of Unsafe Driving Behaviors Events of speeding, distracted driving, and no seatbelt use. Six months/study period
Primary Frequency of Parent-teen Communication Frequency of parent-teen communication about driving safety. This will be measured through a survey asking parents how often they discussed a driving topic with their teen. Six months/study period
Primary Recidivism Recidivism will be measured among teens in all three groups by linking traffic citations and court disposition data with the participating teen's driver's license number. Recidivism during the 12 months following enrollment, including date and type of violation, and days from index violation to subsequent violation will be analyzed. Up to one year post-study period
Primary Quality of Parent-teen Communication The quality of parent-teen communication about driving safety will be measured through an average rating of each driving topic which is recorded by the parent and teen. Six months/study period
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