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临床试验/NCT05696353
NCT05696353进行中(未招募)3 期

Adoption and Implementation of an Evidence-based Safe Driving Program for High-Risk Teen Drivers

Ginger Yang1 个研究点 分布在 1 个国家目标入组 588 人开始时间: 2022年11月17日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
588
试验地点
1
主要终点
Risky Driving Events

研究概览

简要总结

To translate our evidence-based, parent-engagement safe teen driving intervention to a high-risk, rural and urban teen drivers with a traffic violation, and to test the implementation, effectiveness, and cost-effectiveness of the proposed intervention.

详细描述

For this study, 290 teen and parent/guardian dyads will be randomized into one of three study groups for 12 months with 6 months of active data collection. 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. Dyads will be recruited from both urban and rural counties in Ohio following the teen's moving violation conviction. The study will determine the effectiveness and cost-effectiveness of the intervention on teens' risky driving events, unsafe driving behaviors, traffic violation recidivism, and motor vehicle collisions (MVCs), as well as frequency and quality of parent-teen communications about safe driving practices. Additionally, the study will determine the effectiveness and cost-effectiveness of the peer-delivered intervention vs. expert-delivered intervention on the outcomes of the interest. Finally, the study will assess the barriers/facilitators to the adoption and implementation of the intervention in rural and urban families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Teen must be 16 or 17 years old at the time of the moving-related violation
  • •Teen must be found guilty of committing the violation
  • •Teen must possess a valid Ohio provisional driver's license and proof of car insurance
  • •Teen must have access to a vehicle with an On-board Diagnostics II system port (i.e., cars made after 1996) in which they are the primary driver
  • •Teen must have a smart phone with Bluetooth capabilities

排除标准

  • •Teen is unable to drive due to injury, has a suspended driver's license, and/or car damage
  • •Teen has previously received a traffic citation
  • •Vehicle already has an in-vehicle driving feedback system installed
  • •Teen has non-English speaking parents
  • •Teen is currently enrolled in another driving-related study
  • •Teen is a ward of the State
  • •Adults unable to consent
  • •Pregnant women
  • •Prisoners

研究组 & 干预措施

Control Group

No Intervention

The Control Group will have an in-vehicle device installed in the teen's car, but all feedback features will be disabled. Parents assigned into this group will receive no communication training on how to motivate their teen to adopt safe driving habits.

Feedback and Expert-Delivered Parent Communication Intervention Group

Experimental

Teens will have an in-vehicle device installed in their car and the smart phone app downloaded on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents will also receive communication training on how to motivate their teen to adopt safe driving habits via online modules and a video call with a teen driving safety communication expert. A second booster session will occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

干预措施: In-vehicle Device (Combination Product)

Feedback and Expert-Delivered Parent Communication Intervention Group

Experimental

Teens will have an in-vehicle device installed in their car and the smart phone app downloaded on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents will also receive communication training on how to motivate their teen to adopt safe driving habits via online modules and a video call with a teen driving safety communication expert. A second booster session will occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

干预措施: Expert-Delivered Parent Communication Training (Behavioral)

Feedback and Peer-Delivered Parent Communication Intervention Group

Experimental

Teens will have an in-vehicle device installed in their car and the smart phone app download on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents will also receive communication training on how to motivate their teen to adopt safe driving habits via online modules and a video call with a peer trainer who is a parent of teen with a traffic violation and who has received the Expert-delivered Intervention and met the defined peer trainer criteria. A second booster session delivered by the peer trainer will also occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

干预措施: In-vehicle Device (Combination Product)

Feedback and Peer-Delivered Parent Communication Intervention Group

Experimental

Teens will have an in-vehicle device installed in their car and the smart phone app download on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents will also receive communication training on how to motivate their teen to adopt safe driving habits via online modules and a video call with a peer trainer who is a parent of teen with a traffic violation and who has received the Expert-delivered Intervention and met the defined peer trainer criteria. A second booster session delivered by the peer trainer will also occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

干预措施: Peer-Delivered Parent Communication Training (Behavioral)

结局指标

主要结局

Risky Driving Events

时间窗: Six months/study period

Risky driving events are continuously monitored for teens across all three groups using an in-vehicle device and smartphone app. The system automatically detects and records driving events, including hard braking (≤ -0.45 g-force) sudden acceleration (\> 0.35 g-force), speeding (\>10 miles over the posted speed limit), and speed \>75 mph. Event rates are calculated as the number of risky driving events per 1,000 miles driven.

Unsafe Driving Behaviors

时间窗: Six months/study period

Unsafe driving behaviors among teens are continuously monitored across all three study groups using an in-vehicle device and a smartphone app. The system automatically records behaviors such as speeding, and seatbelt nonuse (for selected vehicle makes and model years only), as well as the distance traveled while these behaviors occur. Unsafe behavior rates are calculated as the number of miles involving an unsafe behavior per 1,000 miles driven. Survey data supplement these measures by capturing self-reported distracted driving and seatbelt use for vehicles that are not fully compatible with the in-vehicle device.

次要结局

  • Traffic Violation Recidivism(Up to one-year post-study period)
  • Parent-Teen Communication(At Baseline, Three months, and Six months)

研究者

发起方
Ginger Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ginger Yang

Principal Investigator

Nationwide Children's Hospital

研究点 (1)

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