Trial Outcomes & Findings for Web-based Intervention to Prevent Risky Driving (NCT NCT02319317)
NCT ID: NCT02319317
Last Updated: 2017-11-06
Results Overview
Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Results posted on
2017-11-06
Participant Flow
Confirmation of inclusion and exclusion criteria
Participant milestones
| Measure |
Risky Driving Prevention
Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.
Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
|
Control Group
Web-based behavioral intervention for healthy lifestyles.
Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Web-based Intervention to Prevent Risky Driving
Baseline characteristics by cohort
| Measure |
Risky Driving Prevention
n=31 Participants
Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.
Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
|
Control Group
n=29 Participants
Web-based behavioral intervention for healthy lifestyles.
Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
17.04 years
STANDARD_DEVIATION 0.39 • n=5 Participants
|
16.92 years
STANDARD_DEVIATION 0.30 • n=7 Participants
|
16.98 years
STANDARD_DEVIATION 0.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
Outcome measures
| Measure |
Risky Driving Prevention
n=31 Participants
Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.
Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
|
Control Group
n=29 Participants
Web-based behavioral intervention for healthy lifestyles.
Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
|
|---|---|---|
|
Retention of Participants
|
28 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline (Study Visit 1)Proportion of participants screened, enrolled and randomized
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Study Visit 1) through completion of the intervention.Adherence among the intervention and control group to the intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Study Visit 1) through Study Visit 3Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).Difference between the intervention and control group on self-report measures of driving behaviors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).Difference between the intervention and control group on driving citations and crashes.
Outcome measures
Outcome data not reported
Adverse Events
Risky Driving Prevention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Risky Driving Prevention
n=31 participants at risk
Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.
Risky driving prevention: The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
|
Control Group
n=29 participants at risk
Web-based behavioral intervention for healthy lifestyles.
Control group general health promotion: The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
|
|---|---|---|
|
General disorders
Discomfort during/after driving simulation
|
6.5%
2/31 • Number of events 2
|
0.00%
0/29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place