Trial Outcomes & Findings for Intervention to Improve Driving Practices Among High-Risk Teen Drivers (NCT NCT04317664)

NCT ID: NCT04317664

Last Updated: 2026-02-23

Results Overview

Risky driving events are continuously monitored for teens (240) 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

Six months/study period

Results posted on

2026-02-23

Participant Flow

Parent and teen are enrolled as a dyad only if both agree to participate.

Data listed below reflects number of parent-teen dyads.

Participant milestones

Participant milestones
Measure
Control Group
The Control Group will have the in-vehicle device installed in the teen's car, but all feedback features will be disabled.
Feedback Only Group
The Feedback Only Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens can review their driving data. Teens will also receive biweekly cumulative driving reports. In-vehicle device: 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 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) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.
Feedback and Parent Communication Group
The Feedback and Parent Communication Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens and parents can review their driving data. The parent 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 motivational interviewing professional. A second booster session will also occur two months after the initial training. Both teens and parents will receive a biweekly cumulative driving report. In-vehicle device: The Azūga™ in-vehicle driving feedback technology described earlier will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report. 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, including includes three MI demonstration videos and 26 safe driving lessons.
Overall Study
STARTED
80
80
80
Overall Study
COMPLETED
72
73
77
Overall Study
NOT COMPLETED
8
7
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group
n=160 Participants
The Control Group will have the in-vehicle device installed in the teen's car, but all feedback features will be disabled.
Feedback Only Group
n=160 Participants
The Feedback Only Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens can review their driving data. Teens will also receive biweekly cumulative driving reports. In-vehicle device: 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 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) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.
Feedback and Parent Communication Group
n=160 Participants
The Feedback and Parent Communication Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens and parents can review their driving data. The parent 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 motivational interviewing professional. A second booster session will also occur two months after the initial training. Both teens and parents will receive a biweekly cumulative driving report. In-vehicle device: The Azūga™ in-vehicle driving feedback technology described earlier will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report. 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, including includes three MI demonstration videos and 26 safe driving lessons.
Total
n=480 Participants
Total of all reporting groups
Age, Categorical
Teens · <=18 years
80 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
80 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
80 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
240 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Age, Categorical
Teens · Between 18 and 65 years
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Age, Categorical
Teens · >=65 years
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Age, Categorical
Parents · <=18 years
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Age, Categorical
Parents · Between 18 and 65 years
80 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
78 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
80 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
238 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Age, Categorical
Parents · >=65 years
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
2 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
0 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
2 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Sex: Female, Male
Teens · Female
41 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
41 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
41 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
123 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Sex: Female, Male
Teens · Male
39 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
39 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
39 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
117 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Sex: Female, Male
Parents · Female
55 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
63 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
62 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
180 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Sex: Female, Male
Parents · Male
25 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
17 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
18 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
60 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Ethnicity (NIH/OMB)
Teens · Hispanic or Latino
5 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
6 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
4 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
15 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Ethnicity (NIH/OMB)
Teens · Not Hispanic or Latino
68 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
70 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
68 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
206 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Ethnicity (NIH/OMB)
Teens · Unknown or Not Reported
7 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
4 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
8 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
19 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Ethnicity (NIH/OMB)
Parents · Hispanic or Latino
2 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
3 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
3 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
8 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Ethnicity (NIH/OMB)
Parents · Not Hispanic or Latino
72 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
74 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
71 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
217 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Ethnicity (NIH/OMB)
Parents · Unknown or Not Reported
6 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
3 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
6 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
15 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Race/Ethnicity, Customized
Teens · Black
5 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
7 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
4 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
16 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Race/Ethnicity, Customized
Teens · White
68 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
55 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
69 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
192 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Race/Ethnicity, Customized
Teens · Other
7 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
18 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
7 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
32 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Race/Ethnicity, Customized
Parents · Black
4 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
7 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
5 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
16 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Race/Ethnicity, Customized
Parents · White
72 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
67 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
70 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
209 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Race/Ethnicity, Customized
Parents · Other
4 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
6 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
5 Participants
n=80 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
15 Participants
n=240 Participants • Parents and teens are enrolled in a parent-teen dyad (80 dyads per group, totaling 160 participants per group).
Region of Enrollment
United States
160 Participants
n=160 Participants
160 Participants
n=160 Participants
160 Participants
n=160 Participants
480 Participants
n=480 Participants

PRIMARY outcome

Timeframe: Six months/study period

Risky driving events are continuously monitored for teens (240) 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.

Outcome measures

Outcome measures
Measure
Control Group
n=80 Participants
The Control Group will have the in-vehicle device installed in the teen's car, but all feedback features will be disabled.
Feedback Only Group
n=80 Participants
The Feedback Only Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens can review their driving data. Teens will also receive biweekly cumulative driving reports. In-vehicle device: 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 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) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.
Feedback and Parent Communication Group
n=80 Participants
The Feedback and Parent Communication Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens and parents can review their driving data. The parent 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 motivational interviewing professional. A second booster session will also occur two months after the initial training. Both teens and parents will receive a biweekly cumulative driving report. In-vehicle device: The Azūga™ in-vehicle driving feedback technology described earlier will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report. 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, including includes three MI demonstration videos and 26 safe driving lessons.
Risky Driving Events
101.3 Average number of events per 1000 miles
Standard Deviation 140.4
106.2 Average number of events per 1000 miles
Standard Deviation 108.6
77.7 Average number of events per 1000 miles
Standard Deviation 89.2

PRIMARY outcome

Timeframe: Six months/study period

Unsafe driving behaviors among teens (N = 240) 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.

Outcome measures

Outcome measures
Measure
Control Group
n=80 Participants
The Control Group will have the in-vehicle device installed in the teen's car, but all feedback features will be disabled.
Feedback Only Group
n=80 Participants
The Feedback Only Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens can review their driving data. Teens will also receive biweekly cumulative driving reports. In-vehicle device: 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 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) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.
Feedback and Parent Communication Group
n=80 Participants
The Feedback and Parent Communication Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens and parents can review their driving data. The parent 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 motivational interviewing professional. A second booster session will also occur two months after the initial training. Both teens and parents will receive a biweekly cumulative driving report. In-vehicle device: The Azūga™ in-vehicle driving feedback technology described earlier will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report. 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, including includes three MI demonstration videos and 26 safe driving lessons.
Unsafe Behaviors
Proportion of miles driven above the speeding threshold per trip
0.19 Proportion of miles driven
Standard Deviation 0.3
0.19 Proportion of miles driven
Standard Deviation 0.3
0.16 Proportion of miles driven
Standard Deviation 0.3
Unsafe Behaviors
Proportion of miles driven without a seatbelt
0.09 Proportion of miles driven
Standard Deviation 0.3
0.12 Proportion of miles driven
Standard Deviation 0.3
0.07 Proportion of miles driven
Standard Deviation 0.2

SECONDARY outcome

Timeframe: Up to one year post-study period

Recidivism is assessed by linking traffic citation and court disposition records to participants' driver's license numbers. Data collected include violation dates, types, and intervals between the index and subsequent violations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at baseline, three months, and six months

Parent-teen communication is assessed using REDCap surveys. Teens and parents rate the frequency (0-3) and success (1-10) of discussions about 26 driving skills and safety principles from the past month. Frequency scores range from 0-78, with higher scores indicating more frequent communication, and quality scores are weighted averages expressed as percentages (1-100%), with higher scores indicating higher quality communication. Additionally, one voice-recorded conversation per survey is also coded by trained raters for active listening, OARS (i.e.,open questions, affirmations, reflective listening, and summary reflections) use solicitation of the teen's perspective, focus on behaviors, and emotional expression, with each behavior scored 0-3 to generate a summary quality score, with higher scores indicating higher quality communication.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Six months/study period

Engagement with the parent communication training is measured among parents in the Feedback and Parent Communication Group using a self-report questionnaire and online tracking.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Six months/study period

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Three months/study period

Communication training delivery is measured among parents in the Feedback and Parent Communication Group and communication specialist via participant and trainer surveys completed immediately after each training session using the Behavior Change Counseling Index.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Feedback Only Group

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Feedback and Parent Communication Group

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Control Group
n=80 participants at risk
The Control Group will have the in-vehicle device installed in the teen's car, but all feedback features will be disabled.
Feedback Only Group
n=80 participants at risk
The Feedback Only Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens can review their driving data. Teens will also receive biweekly cumulative driving reports. In-vehicle device: 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 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) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.
Feedback and Parent Communication Group
n=80 participants at risk
The Feedback and Parent Communication Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens and parents can review their driving data. The parent 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 motivational interviewing professional. A second booster session will also occur two months after the initial training. Both teens and parents will receive a biweekly cumulative driving report. In-vehicle device: The Azūga™ in-vehicle driving feedback technology described earlier will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report. 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, including includes three MI demonstration videos and 26 safe driving lessons.
Social circumstances
Teen Vehicle Crash
3.8%
3/80 • Number of events 3 • 6 months
Adverse Events are recorded for teen driver participants (240). Parent participants were not assessed for Adverse Events.
3.8%
3/80 • Number of events 3 • 6 months
Adverse Events are recorded for teen driver participants (240). Parent participants were not assessed for Adverse Events.
3.8%
3/80 • Number of events 3 • 6 months
Adverse Events are recorded for teen driver participants (240). Parent participants were not assessed for Adverse Events.

Additional Information

Dr. Jingzhen Yang

Nationwide Children's Hospital

Phone: 614-355-5852

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place