Teen Driving Translation Study (NIH)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Drive, Recidivism, Communication, Feedback, Psychological

Intervention / Treatment
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* Combination Product: In-vehicle Device
* Behavioral: Expert-Delivered Parent Communication Training
* Behavioral: Peer-Delivered Parent Communication Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Teen must be 16 or 17 years old at the time of the moving-related violation Teen must be a first-time offender and 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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. | |
| Experimental: Feedback and Expert-Delivered Parent Communication Intervention Group<br>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. | Combination Product: In-vehicle Device<br>* The Azūga™ 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 smart phone app (downloaded on the teen's smart phone), 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 via the smart phone app and study website; and 3) A customized biweekly driving summary report via study website.<br>* Other names: In-vehicle Driving Feedback Technology;Behavioral: Expert-Delivered Parent Communication Training<br>* An individualized virtual training in communication strategies about teen driving safety along with a booster session will be delivered by a traffic safety communication specialist to parents in the Feedback and Expert-Delivered Parent Communication Intervention Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.<br>* Other names: Expert-Delivered Motivational Interviewing Training;|
| Experimental: Feedback and Peer-Delivered Parent Communication Intervention Group<br>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. | Combination Product: In-vehicle Device<br>* The Azūga™ 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 smart phone app (downloaded on the teen's smart phone), 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 via the smart phone app and study website; and 3) A customized biweekly driving summary report via study website.<br>* Other names: In-vehicle Driving Feedback Technology;Behavioral: Peer-Delivered Parent Communication Training<br>* An individualized virtual training in communication strategies about teen driving safety along with a booster session will be delivered by a peer trainer who is a parent of teen with traffic citation and has participated in the Feedback and Peer-Delivered Parent Communication Intervention Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.<br>* Other names: Peer-Delivered Motivational Interviewing Training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risky driving events | Risky driving events (hard braking, sudden acceleration) will be collected among teens in the intervention groups and control group using the Azūga™ in-vehicle device. The number and type of driving event, including hard breaking (≤ -0.45 g-force) and sudden acceleration (> 0.35 g-force), will be automatically coded and counted in the system. The rates will be computed by dividing events by miles driven then multiplying by 1000. | Daily overtime for six months following enrollment | 
| Unsafe driving behaviors | Using the Azūga™ in-vehicle device and smart phone app, the investigators will collect data in both intervention groups and the control group on teen's unsafe driving behaviors (speeding, distracted driving, no seatbelt use). The duration (e.g., miles driven) and type of driving behaviors, including speeding (>10 miles over the posted speed limit), and no seatbelt use, will be automatically coded and counted in the system. The proportions will be calculated by dividing by miles driven then multiplying by 1000 (e.g., proportion of 1,000 miles in which a seatbelt was not worn). | Daily overtime for six months following enrollment | 
| Direct Costs: 3 Years | Direct costs refer to the personnel and non-personnel costs that can be assigned to the intervention (i.e., STS+). Personnel costs include service time and the proportion of staff time allocated to implement STS+ and non-personnel costs refer to other items needed for delivering STS+, such as equipment, supplies and materials. Examples of direct costs include staff time required to 1) deliver the intervention, 2) train the peer trainers, 3) install, manage, and maintain the driving feedback technology, 4) manage the STS+ website platform, and 5) train participants to use the driving feedback technology and STS+ website platform. Direct cost data will be collected yearly from all dyads using a cost data collection protocol and template that includes annual costs for personnel, technology, training requirements, supplies, and infrastructure. | 3 years | 
| Adoption - Courts: 3 Years | Adoption will be measured by comparing characteristics of participating county courts (Franklin, Greene, Perry, and Wyandot Juvenile Traffic Courts) to county courts in the rest of Ohio (e.g., court hours, location, the number of staff, the number of cases). The investigators will also conduct interviews with participating court officials to identify facilitators and barriers to program adoption. | 3 years | 
| Adoption - Participants | The investigators will also conduct interviews with a randomly selected sample of dyads in each intervention group (n=116, 58 dyads for each intervention group) to identify facilitators and barriers to program adoption. | At 6-month follow-up | 
| Change in Reach | Reach will be measured by comparing characteristics of teens who enrolled in the study to those who declined participation (e.g., demographics, residence location, citation history). The investigators will assess the number of eligible participants who are offered participation on each recruitment day, the number of those who were offered participation and declined as well as participation and drop-out rates. | Yearly for 3 years | 
| Implementation Fidelity - BECCI | Implementation fidelity will be measured among parents in both intervention groups, and among the expert and peer trainers immediately after the intervention using the Behavior Change Counseling Index (BECCI). The BECCI measures the degree to which the intervention is delivered as intended and involves 11 items rated on a scale of 0 to 4. The average of all items will be calculated, with higher scores representing greater fidelity. | After completion of each intervention session, up to three years | 
| Implementation Fidelity - Fidelity Checklist | Implementation fidelity will be measured among the expert and peer trainers immediately after the intervention using a fidelity checklist. The fidelity checklist will measure intervention fidelity including conceptual accuracy and adherence, and responsiveness to the needs of participants. Trained Raters will review a sample of recorded training and booster sessions and complete the fidelity checklist. | After completion of each intervention session, up to three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-teen communications about driving safety | All participating dyads will be asked to rate the frequency of parent-teen conversations on each of the 24 common driving skills/safety principles, discussed in the past month (0=never to 3=often) and level of success (1=poor to 10=excellent). Frequency of parent-teen communication scores will range from 0 to 78, with higher scores indicating more frequent communication. Quality of parent-teen communication scores will be calculated by averaging ratings for all skills/principles addressed, and then weighting them based on the maximum score possible, and then recording scores as a percentage (possible range= 1% - 100%). | During 6 months of enrollment | 
| Traffic Violation Recidivism | Traffic violation recidivism will be measured among teens in both intervention groups and the control group 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. The time of recidivism may not be observed when the 12-month study participation is completed and thus, it will be considered as censored at month 12 (end of study participation). | At 12 months following enrollment | 
| Motor Vehicle Collision | Motor vehicle collision (MVC) will be measured among teens in both intervention groups and the control group by linking crash report data with the participating teen's driver's license number. Motor vehicle collision (MVC) during the 12 months following enrollment, including date and type of crash will be analyzed. The time of MVC may not be observed when the 12-month study participation is completed and thus, it will be considered as censored at month 12 (end of study participation). | At 12 months following enrollment | 
| Indirect Costs: 3 Years | Indirect costs are those costs that are not directly associated with the intervention but that support the delivery of the intervention (e.g., provide private space in court house for the recruitment). For indirect costs, staff interviews will be used to determine the percent of their time and resources needed to support the delivery of the intervention. | 3 years | 
| Maintenance | Maintenance will be measured by assessing parents' intention to continue using the STS+ program and teens' intention to continue using the in-vehicle device and app. The investigators will interview court officials, peer trainers, and parent-teen dyads in each intervention group (approximately 50% of intervention dyads) at the end of the study to explore perceived facilitators and barriers to program implementation and sustainability in their community. | At 6-month follow-up |