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An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498575
First Posted: December 23, 2011
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
State Farm Insurance Co.
Bryn Mawr Rehabilitation Hospital
GFK Knowledge Networks
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
Results First Submitted: January 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Novice Teen Driver Training
Intervention: Behavioral: Teen driving plan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From December 2011 to August 2012, participants were recruited from 5 sources: (1) local high schools; (2) The Children's Hospital of Philadelphia (CHOP) primary care practices; (3) local licensing centers; (4) community events; and (5) targeted ads in online venues. Fliers, letters, and ads describing the study were distributed via these channels.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A subset of the teens were assigned to complete the On Road Driving (ODA) assessment. Study participation lasted from 6-36 months based on licensure status - all dyads participated in the study for 6 months, after which participation continued until teens obtained their junior driver’s license (up to a max of 36 months from enrollment).

Reporting Groups
  Description
Teen Driving Plan (TDP)

Access to web-based driving intervention

Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver.

Usual Practice (Control) Use of typical supervised practice driving resources

Participant Flow for 2 periods

Period 1:   Overall Sample
    Teen Driving Plan (TDP)   Usual Practice (Control)
STARTED   610   414 
COMPLETED   550   400 
NOT COMPLETED   60   14 
Withdrawal by Subject                60                14 

Period 2:   On the Road Driving Assessment (ODA)
    Teen Driving Plan (TDP)   Usual Practice (Control)
STARTED   128   89 
COMPLETED   86   65 
NOT COMPLETED   42   24 
Withdrawal by Subject                19                6 
Protocol Violation                23                18 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Teen Driving Plan

Access to web-based driving intervention

Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver.

Usual Practice Use of typical supervised practice driving resources
Total Total of all reporting groups

Baseline Measures
   Teen Driving Plan   Usual Practice   Total 
Overall Participants Analyzed 
[Units: Participants]
 610   414   1024 
Age, Customized 
[Units: Years]
Median (Inter-Quartile Range)
     
Teens (n=315, 210)   16.2 
 (16.1 to 16.6) 
 16.3 
 (16.1 to 16.7) 
 16.2 
 (16 to 17) 
Parents (n=295, 204)   48.4 
 (44.7 to 51.8) 
 48.9 
 (45.8 to 51.9) 
 48.5 
 (45 to 52) 
Gender 
[Units: Participants]
     
Female   385   278   663 
Male   225   136   361 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   14   9   23 
Not Hispanic or Latino   591   402   993 
Unknown or Not Reported   5   3   8 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   11   17   28 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   68   46   114 
White   516   342   858 
More than one race   5   4   9 
Unknown or Not Reported   9   4   13 


  Outcome Measures

1.  Primary:   Late Driving Performance in On-road Assessment (ODA) Test   [ Time Frame: 24 weeks after enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Moderate attrition (although no evidence of selective attrition); limited generalizability of results; and eight teenagers were not administered the highway module and were censored from analysis.


  More Information
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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.


Results Point of Contact:  
Name/Title: Dennis Durbin, MD, MSCE
Organization: The Children's Hospital of Philadelphia
phone: 215-590-7331
e-mail: DURBIND@EMAIL.CHOP.EDU


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01498575     History of Changes
Other Study ID Numbers: 11-008203
First Submitted: December 20, 2011
First Posted: December 23, 2011
Results First Submitted: January 22, 2015
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015