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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04317547
Other study ID # 3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2020
Est. completion date January 31, 2024

Study information

Verified date May 2023
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

Steering Teens Safe (STS) is an evidence-based and parent-focused intervention developed by the investigators, which aims to improve safe teen driving practices by enhancing parental communication skills. The objective of this translation study is to assess the effect of STS on driving outcomes among teen drivers who have committed a traffic violation, and to assess the adoption and implementation fidelity of STS in a county court setting and among these high-risk teen drivers and their parents. The investigators will test the following specific aims: Aim 1: Determine the effects of the intervention on parent-teen communications and risky driving outcomes (risky driving events, unsafe driving behaviors, and recidivism) among teen drivers with a traffic violation(s). Aim 2: Assess the adoption of the intervention and implementation fidelity We will enroll 90 parent-teen dyads, comprised a teen driver (16 to 17 years) who committed a moving violation and a parent/legal guardian, from the Ohio Franklin County Juvenile Traffic Court following the teens' mandatory court hearing. Enrolled dyads will be randomly assigned to 1 of 2 study groups (n=45/group): 1) Control, device installation only with no feedback to nor communication training for parents, or 2) Intervention, device feedback to teens and parents, and parents will also receive individualized virtual communication training. The expected outcome is to establish the effectiveness of STS augmented with driving feedback technology, and to establish the implementation fidelity of STS in a court setting.


Description:

Motor vehicle collisions (MVCs) are the leading cause of death among teenagers in the United States. Teen drivers who have committed a traffic violation are at an even greater risk for MVCs than their counterparts. While parent-focused interventions are an effective strategy to improve teen driving safety, most of these interventions target teen drivers are implemented as universal interventions (for teens of all risk profiles). Evidence on the effectiveness of these evidence-based interventions when translated and implemented among high-risk teen drivers such as those with a traffic citation is lacking. The current project is significant because it will translate the STS program to the needs of high-risk teen drivers who have committed a traffic violation and their parents. This study is innovative because it partners with the local court system, and utilizes novel and cutting-edge in-vehicle technology. The findings of the current study will have a significant impact on juvenile traffic court's practices and policies aimed to improve teen driving safety by reducing MVC-related crashes, injuries, and deaths.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date January 31, 2024
Est. primary completion date January 31, 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; - Ward of the State; - Non-English speaking parent.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Steering Teens Safe (STS)
The goal of STS is to provide intervention parents with guidance and communication skills, which will enable parents to effectively communicate with their teens about specific driving safety topics (e.g., speeding, seatbelt use, distracted driving). Our proposed parent training has two components: an individualized virtual communication training (provided to parents via Skype by a trained research team member) and a parent-teen safe driving communication guide (available online).
Driving Feedback Technology.
The driving feedback technology will include the Azuga™ in-vehicle device and smartphone app.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Ginger Yang University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (31)

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

Beck KH, Shattuck T, Raleigh R. Parental predictors of teen driving risk. Am J Health Behav. 2001 Jan-Feb;25(1):10-20. doi: 10.5993/ajhb.25.1.2. — View Citation

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

Franklin County Court of Common Pleas. Meet the Magistrate. [Accessed 2018 Jan 4]. https://drj.fccourts.org/DRJ.aspx?PN=Susan_House.htm

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

Gielen AC, Frattaroli S, Pollack KM, Peek-Asa C, Yang JG. How the science of injury prevention contributes to advancing home fire safety in the USA: successes and opportunities. Inj Prev. 2018 Jun;24(Suppl 1):i7-i13. doi: 10.1136/injuryprev-2017-042356. Epub 2018 Feb 26. — 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

Goodwin AH, Foss RD, Margolis LH, Harrell S. Parent comments and instruction during the first four months of supervised driving: an opportunity missed? Accid Anal Prev. 2014 Aug;69:15-22. doi: 10.1016/j.aap.2014.02.015. Epub 2014 Mar 2. — View Citation

Hartos J, Eitel P, Simons-Morton B. Parenting practices and adolescent risky driving: a three-month prospective study. Health Educ Behav. 2002 Apr;29(2):194-206. doi: 10.1177/109019810202900205. — View Citation

Insurance Institute for Highway Safety (IIHS). Fatality Facts: Teenagers 2015. Arlington (VA): The Institute; 2017 [cited 2018 Jan 4]. http://www.iihs.org/iihs/topics/t/teenagers/fatalityfacts/teenagers

Masten SV, Foss RD, Marshall SW. Graduated driver licensing and fatal crashes involving 16- to 19-year-old drivers. JAMA. 2011 Sep 14;306(10):1098-103. doi: 10.1001/jama.2011.1277. — View Citation

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

Mirman JH, Albert WD, Curry AE, Winston FK, Fisher Thiel MC, Durbin DR. TeenDrivingPlan effectiveness: the effect of quantity and diversity of supervised practice on teens' driving performance. J Adolesc Health. 2014 Nov;55(5):620-6. doi: 10.1016/j.jadohealth.2014.04.010. Epub 2014 Jun 9. — View Citation

Mirman JH, Curry AE, Winston FK, Wang W, Elliott MR, Schultheis MT, Fisher Thiel MC, Durbin DR. Effect of the teen driving plan on the driving performance of teenagers before licensure: a randomized clinical trial. JAMA Pediatr. 2014 Aug;168(8):764-71. doi: 10.1001/jamapediatrics.2014.252. — View Citation

Peek-Asa C, Cavanaugh JE, Yang J, Chande V, Young T, Ramirez M. Steering teens safe: a randomized trial of a parent-based intervention to improve safe teen driving. BMC Public Health. 2014 Jul 31;14:777. doi: 10.1186/1471-2458-14-777. — View Citation

Peek-Asa C, Reyes M, Hamman C, Butcher B, Cavanaugh J. In-vehicle video feedback systems and parent engagement: a randomized trial to improve safe teen driving. Transportation Research Board. January 2016. Washington D.C.

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

Ramirez M, Yang J, Young T, Roth L, Garinger A, Snetselaar L, Peek-Asa C. Implementation evaluation of steering teens safe: engaging parents to deliver a new parent-based teen driving intervention to their teens. Health Educ Behav. 2013 Aug;40(4):426-34. doi: 10.1177/1090198112459517. Epub 2012 Oct 4. — View Citation

Simons-Morton B. Parent involvement in novice teen driving: rationale, evidence of effects, and potential for enhancing graduated driver licensing effectiveness. J Safety Res. 2007;38(2):193-202. doi: 10.1016/j.jsr.2007.02.007. Epub 2007 Mar 26. — View Citation

Simons-Morton BG, Hartos JL, Leaf WA, Preusser DF. Persistence of effects of the Checkpoints program on parental restrictions of teen driving privileges. Am J Public Health. 2005 Mar;95(3):447-52. doi: 10.2105/AJPH.2003.023127. — View Citation

Simons-Morton BG, Ouimet MC, Catalano RF. Parenting and the young driver problem. Am J Prev Med. 2008 Sep;35(3 Suppl):S294-303. doi: 10.1016/j.amepre.2008.06.018. — View Citation

Simons-Morton BG, Ouimet MC, Zhang Z, Klauer SE, Lee SE, Wang J, Albert PS, Dingus TA. Crash and risky driving involvement among novice adolescent drivers and their parents. Am J Public Health. 2011 Dec;101(12):2362-7. doi: 10.2105/AJPH.2011.300248. Epub 2011 Oct 20. — 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

Winston FK, Mirman JH, Curry AE, Pfeiffer MR, Elliott MR, Durbin DR. Engagement with the TeenDrivingPlan and diversity of teens' supervised practice driving: lessons for internet-based learner driver interventions. Inj Prev. 2015 Feb;21(1):4-9. doi: 10.1136/injuryprev-2014-041212. Epub 2014 Jun 10. — View Citation

Winston FK, Puzino K, Romer D. Precision prevention: time to move beyond universal interventions. Inj Prev. 2016 Apr;22(2):87-91. doi: 10.1136/injuryprev-2015-041691. Epub 2015 Aug 13. No abstract available. — View Citation

Yang J, Campo S, Ramirez M, Krapfl JR, Cheng G, Peek-Asa C. Family communication patterns and teen drivers' attitudes toward driving safety. J Pediatr Health Care. 2013 Sep-Oct;27(5):334-41. doi: 10.1016/j.pedhc.2012.01.002. Epub 2012 Feb 22. — View Citation

Zakrajsek JS, Shope JT, Greenspan AI, Wang J, Bingham CR, Simons-Morton BG. Effectiveness of a brief parent-directed teen driver safety intervention (Checkpoints) delivered by driver education instructors. J Adolesc Health. 2013 Jul;53(1):27-33. doi: 10.1016/j.jadohealth.2012.12.010. Epub 2013 Mar 6. — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Parent-teen communications Frequency of parent-teen communication about driving safety. This will be measured through a survey asking parents how often they discussed the topic with their teen on driving topics. Six months/study period
Primary Number of Risky driving events and unsafe behavior rates Events of hard braking, sudden acceleration, speeding, distracted driving, and no seatbelt use. Six months/study period
Primary Recidivism Recidivism will be measured among teens in both 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 Adoption of the intervention Adoption of the intervention by using publicly available court data from Franklin County Juvenile Traffic Court and compare it to all other juvenile traffic courts in Ohio. We will also use participant characteristic data and compare it to non-participating teens with a moving violation in Ohio. Six months/study period
Primary Implementation fidelity Engagement with community training via a self-report questionnaire, engagement with device feedback via Google Analytics, and a fidelity checklist will be combined to report implementation fidelity Six months/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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