Trial Outcomes & Findings for An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving (NCT NCT01498575)
NCT ID: NCT01498575
Last Updated: 2015-03-17
Results Overview
The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.
COMPLETED
NA
1024 participants
24 weeks after enrollment
2015-03-17
Participant Flow
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.
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).
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Sample
STARTED
|
610
|
414
|
|
Overall Sample
COMPLETED
|
550
|
400
|
|
Overall Sample
NOT COMPLETED
|
60
|
14
|
|
On the Road Driving Assessment (ODA)
STARTED
|
128
|
89
|
|
On the Road Driving Assessment (ODA)
COMPLETED
|
86
|
65
|
|
On the Road Driving Assessment (ODA)
NOT COMPLETED
|
42
|
24
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Sample
Withdrawal by Subject
|
60
|
14
|
|
On the Road Driving Assessment (ODA)
Withdrawal by Subject
|
19
|
6
|
|
On the Road Driving Assessment (ODA)
Protocol Violation
|
23
|
18
|
Baseline Characteristics
An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving
Baseline characteristics by cohort
| Measure |
Teen Driving Plan
n=610 Participants
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
n=414 Participants
Use of typical supervised practice driving resources
|
Total
n=1024 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
225 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Customized
Teens (n=315, 210)
|
16.2 years
n=5 Participants
|
16.3 years
n=7 Participants
|
16.2 years
n=5 Participants
|
|
Age, Customized
Parents (n=295, 204)
|
48.4 years
n=5 Participants
|
48.9 years
n=7 Participants
|
48.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
385 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
663 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
591 Participants
n=5 Participants
|
402 Participants
n=7 Participants
|
993 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
68 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
516 Participants
n=5 Participants
|
342 Participants
n=7 Participants
|
858 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after enrollmentPopulation: 512 teen-parent dyads were eligible and agreed to participate. Of these, 217 teens were scheduled to complete the ODA (128 were randomized to Teen Driving Plan (TDP), 89 to Usual Practice). Participant attrition over the time of the study resulted in 151 teens (86 TDP and 65 control) completing the 24-week ODA.
The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.
Outcome measures
| Measure |
Teen Driving Plan (TDP)
n=86 Participants
Access to web-based driving intervention that provides practice supervisors with specific guidance for facilitating supervision of teens' practice drives across several environments and conditions (eg., highways, commercial districts) using brief instructional videos and resources.
|
Usual Practice (Control)
n=65 Participants
Participants received a hard copy of the Pennsylvania driver's manual, also available online and at licensing centers.
|
|---|---|---|
|
Late Driving Performance in On-road Assessment (ODA) Test
|
5 Participants
|
10 Participants
|
Adverse Events
Teen Driving Plan (TDP)
Usual Practice (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dennis Durbin, MD, MSCE
The Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place