Accidents, Traffic, Adolescent, Attention, Motor Vehicles
Conditions
Brief summary
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days.
Detailed description
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving teen drivers licensed in the previous 90 days. The intervention will focus on promoting teen driver attention to the roadway. The investigators will use a randomized controlled trial (RCT) experimental design for this feasibility study, randomizing to the intervention or control group. The investigators will complete a baseline assessment and follow up with participants at 1-month, 3-months and 6-months post-intervention delivery. This study will provide information on the feasibility of the web-based intervention to prevent risky driving and estimation of effect size of the intervention on simulated driving performance, self-reported driving behaviors, crash and citation data.
Interventions
BEHAVIORALRisky 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.
BEHAVIORALControl 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.
Sponsors
National Institute of Nursing Research (NINR)
Children's Hospital of Philadelphia
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible). 2. Pennsylvania driver's license for 90 days or less at time of assent 3. Personal email address and computer and internet access 4. Willingness to travel to CHOP twice to complete simulated assessment 5. Ability to read and write English
Exclusion criteria
1. Self-reported of claustrophobia, migraine headaches, or motion sickness 2. Self-reported current pregnancy 3. . Participation in a Center for Injury Research and Prevention teen driving study with the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of Participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Randomized | Baseline (Study Visit 1) | Proportion of participants screened, enrolled and randomized |
| Adherence | Baseline (Study Visit 1) through completion of the intervention. | Adherence among the intervention and control group to the intervention. |
| Simulated Driving Performance | Baseline (Study Visit 1) through Study Visit 3 | Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives). |
| Self-report Driving Behaviors | 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. |
| Driving Citations and Crashes | Baseline (Study Visit 1) through Study Visit 4 (around 6 months). | Difference between the intervention and control group on driving citations and crashes. |
Countries
United States
Participant flow
Pre-assignment details
Confirmation of inclusion and exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Control Group | Risky Driving Prevention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 29 Participants | 31 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 16.92 years STANDARD_DEVIATION 0.3 | 17.04 years STANDARD_DEVIATION 0.39 | 16.98 years STANDARD_DEVIATION 0.35 |
| Region of Enrollment United States | 29 participants | 31 participants | 60 participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 2 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Retention of Participants
Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
Time frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Risky Driving Prevention | Retention of Participants | 28 Participants |
| Control Group | Retention of Participants | 28 Participants |
Secondary
Adherence
Adherence among the intervention and control group to the intervention.
Time frame: Baseline (Study Visit 1) through completion of the intervention.
Secondary
Driving Citations and Crashes
Difference between the intervention and control group on driving citations and crashes.
Time frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Secondary
Proportion of Participants Randomized
Proportion of participants screened, enrolled and randomized
Time frame: Baseline (Study Visit 1)
Secondary
Self-report Driving Behaviors
Difference between the intervention and control group on self-report measures of driving behaviors.
Time frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Secondary
Simulated Driving Performance
Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).
Time frame: Baseline (Study Visit 1) through Study Visit 3