Trial Outcomes & Findings for A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01322646)
NCT ID: NCT01322646
Last Updated: 2022-05-11
Results Overview
Frequency count of risky driving events (e.g., abrupt braking, hard acceleration, abrupt swerving) recorded by engine performance monitor installed in the car. Events were counted and a greater frequency indicated more risky driving. The average number of risky driving events, collected over a four-week period at each assessment point were used as the dependent measure.
COMPLETED
NA
172 participants
Follow up period after the intervention (1 year)
2022-05-11
Participant Flow
Participant milestones
| Measure |
Driver Training
Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
Driving Simulator Practice: Practice Driving on a driving simulator
|
STEER Program
Driver Education STEER Program
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
STEER Program: 8-session behavioral parent training and teen social skills/communication training program
Driving Simulator Practice: Practice Driving on a driving simulator
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
|
Overall Study
COMPLETED
|
83
|
84
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Driver Training
n=86 Participants
Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
Driving Simulator Practice: Practice Driving on a driving simulator
|
STEER Program
n=86 Participants
Driver Education STEER Program
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
STEER Program: 8-session behavioral parent training and teen social skills/communication training program
Driving Simulator Practice: Practice Driving on a driving simulator
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
86 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.88 years
STANDARD_DEVIATION .65 • n=5 Participants
|
16.98 years
STANDARD_DEVIATION .7 • n=7 Participants
|
16.92 years
STANDARD_DEVIATION .67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Follow up period after the intervention (1 year)Frequency count of risky driving events (e.g., abrupt braking, hard acceleration, abrupt swerving) recorded by engine performance monitor installed in the car. Events were counted and a greater frequency indicated more risky driving. The average number of risky driving events, collected over a four-week period at each assessment point were used as the dependent measure.
Outcome measures
| Measure |
Driver Training
n=84 Participants
Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
Driving Simulator Practice: Practice Driving on a driving simulator
|
STEER Program
n=83 Participants
Driver Education STEER Program
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
STEER Program: 8-session behavioral parent training and teen social skills/communication training program
Driving Simulator Practice: Practice Driving on a driving simulator
|
|---|---|---|
|
Number of Risky Driving Events Assessed by On-Board Driving Monitor
|
3.20 events
Standard Error .58
|
3.95 events
Standard Error .73
|
PRIMARY outcome
Timeframe: Follow-up period after the intervention (12 weeks)Parents and teens discussed two recent issues and these discussions were coded using The Interaction Behavior Code (IBC). The IBC is a behavioral coding system designed to assess global impressions of parent-adolescent problem-solving and communication behavior. Coders were undergraduates who were unaware of both study hypothesis and group assignment. Coders were instructed to rate 32 behavioral items related to positive and negative parenting in terms of their presence or absence of the behaviors (Items 1-22) or the how often specific parenting behaviors occurred for Items 23-32 ("no" = 0 points, "a little" = .5 point, and "alot" = 1 point). Coders scores were summed across the 32 items and scores fore each scale could range from 0-32. Thus for the positive parenting scale, higher scores, ranging from 0-32, indicated improvement.
Outcome measures
| Measure |
Driver Training
n=84 Participants
Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
Driving Simulator Practice: Practice Driving on a driving simulator
|
STEER Program
n=83 Participants
Driver Education STEER Program
CarChipPro: On board driving monitor
Driver's Education: 10 Session License to Learn Program.
STEER Program: 8-session behavioral parent training and teen social skills/communication training program
Driving Simulator Practice: Practice Driving on a driving simulator
|
|---|---|---|
|
Positive Parenting Observational Data
|
.46 score on a scale
Standard Error .01
|
.44 score on a scale
Standard Error .01
|
Adverse Events
Driver Training
STEER Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place