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

This study has been completed.
Sponsor:
Collaborators:
State Farm Insurance Co.
Bryn Mawr Rehabilitation Hospital
GFK Knowledge Networks
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01498575
First received: December 20, 2011
Last updated: March 3, 2015
Last verified: March 2015
Results First Received: January 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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  
Number of Participants  
[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


No publications provided by Children's Hospital of Philadelphia

Publications automatically indexed to this study:

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01498575     History of Changes
Other Study ID Numbers: 11-008203
Study First Received: December 20, 2011
Results First Received: January 22, 2015
Last Updated: March 3, 2015
Health Authority: United States: Institutional Review Board