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| ID | Type | Description | Link |
|---|---|---|---|
| R00NR013548 | U.S. NIH Grant/Contract | View source | |
| 14-011336 | Other Identifier | Children's Hospital of Philadelphia IRB | |
| 821064 | Other Identifier | University of Pennsylvania IRB |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Children's Hospital of Philadelphia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risky driving prevention | Experimental | Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers. |
|
| Control group | Experimental | Web-based behavioral intervention for healthy lifestyles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risky driving prevention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of Participants | Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4. | Baseline (Study Visit 1) through Study Visit 4 (around 6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Randomized | Proportion of participants screened, enrolled and randomized | Baseline (Study Visit 1) |
| Adherence | Adherence among the intervention and control group to the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine C McDonald, PhD, RN | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4217 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29701615 | Derived | McDonald CC, Sommers MS, Fargo JD, Seacrist T, Power T. Simulated Driving Performance, Self-Reported Driving Behaviors, and Mental Health Symptoms in Adolescent Novice Drivers. Nurs Res. 2018 May/Jun;67(3):202-211. doi: 10.1097/NNR.0000000000000270. |
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Confirmation of inclusion and exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention of Participants | Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4. | Posted | Count of Participants | Participants | Baseline (Study Visit 1) through Study Visit 4 (around 6 months). |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort during/after driving simulation | General disorders | Systematic Assessment | Dizziness or Nausea during/after driving simulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine McDonald. PhD, RN | University of Pennsylvania | 2157468355 | mcdonalc@nursing.upenn.edu |
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| Control group general health promotion | Behavioral | 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. |
|
| Baseline (Study Visit 1) through completion of the intervention. |
| Simulated Driving Performance | Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives). | Baseline (Study Visit 1) through Study Visit 3 |
| Self-report Driving Behaviors | Difference between the intervention and control group on self-report measures of driving behaviors. | Baseline (Study Visit 1) through Study Visit 4 (around 6 months). |
| Driving Citations and Crashes | Difference between the intervention and control group on driving citations and crashes. | Baseline (Study Visit 1) through Study Visit 4 (around 6 months). |
| Philadelphia |
| Pennsylvania |
| 19104-4217 |
| United States |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Proportion of Participants Randomized | Proportion of participants screened, enrolled and randomized | Not Posted | Baseline (Study Visit 1) | Participants |
| Secondary | Adherence | Adherence among the intervention and control group to the intervention. | Not Posted | Baseline (Study Visit 1) through completion of the intervention. | Participants |
| 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). | Not Posted | Baseline (Study Visit 1) through Study Visit 3 | Participants |
| Secondary | Self-report Driving Behaviors | Difference between the intervention and control group on self-report measures of driving behaviors. | Not Posted | Baseline (Study Visit 1) through Study Visit 4 (around 6 months). | Participants |
| Secondary | Driving Citations and Crashes | Difference between the intervention and control group on driving citations and crashes. | Not Posted | Baseline (Study Visit 1) through Study Visit 4 (around 6 months). | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 2 |
| 31 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
|
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