Web-based Intervention to Prevent Risky Driving

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02319317
• Collaborator: National Institute of Nursing Research (NINR) (NIH), Children's Hospital of Philadelphia (Other)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 30
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent; Accidents, Traffic; Attention; Motor Vehicles	Behavioral: Risky driving prevention; Behavioral: Control group general health promotion	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Promoting Teen Health: A Web-based Intervention to Prevent Risky Driving
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Risky driving prevention Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.	Behavioral: 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.
Experimental: Control group Web-based behavioral intervention for healthy lifestyles.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Proportion of Participants Randomized [Baseline (Study Visit 1)]

   Proportion of participants screened, enrolled and randomized

2. Adherence [Baseline (Study Visit 1) through completion of the intervention.]

   Adherence among the intervention and control group to the intervention.

3. 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).

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-4217
2	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4217

Sponsors and Collaborators

• University of Pennsylvania
• National Institute of Nursing Research (NINR)
• Children's Hospital of Philadelphia

Investigators

• Principal Investigator: Catherine C McDonald, PhD, RN, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02319317
• Other Study ID Numbers: R00NR013548; R00NR013548; 14-011336; 821064
• First Posted: Dec 18, 2014
• Last Update Posted: Nov 6, 2017
• Last Verified: Oct 1, 2017

Study Results

Participant Flow

Pre-assignment Detail	Confirmation of inclusion and exclusion criteria

Arm/Group Title	Risky Driving Prevention	Control Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	31	29
COMPLETED	31	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Risky Driving Prevention	Control Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	31	29	60
Age (Count of Participants)
<=18 years	31 100%	29 100%	60 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17.04 (0.39)	16.92 (0.30)	16.98 (0.35)
Sex: Female, Male (Count of Participants)
Female	21 67.7%	19 65.5%	40 66.7%
Male	10 32.3%	10 34.5%	20 33.3%
Region of Enrollment (participants) [Number]
United States	31 100%	29 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Retention of Participants
Description	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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Risky Driving Prevention	Control Group
Arm/Group Description	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.	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.
Measure Participants	31	29
Count of Participants [Participants]	28 90.3%	28 96.6%

2. Secondary Outcome

Title	Proportion of Participants Randomized
Description	Proportion of participants screened, enrolled and randomized
Time Frame	Baseline (Study Visit 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Adherence
Description	Adherence among the intervention and control group to the intervention.
Time Frame	Baseline (Study Visit 1) through completion of the intervention.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Simulated Driving Performance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Self-report Driving Behaviors
Description	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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Driving Citations and Crashes
Description	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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Risky Driving Prevention		Control Group
Arm/Group Description	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.		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.
All Cause Mortality
	Risky Driving Prevention		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)
Serious Adverse Events
	Risky Driving Prevention		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Risky Driving Prevention		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/31 (6.5%)		0/29 (0%)
General disorders
Discomfort during/after driving simulation	2/31 (6.5%)	2	0/29 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.