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A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01322646
Enrollment
172
Registered
2011-03-24
Start date
2010-07-31
Completion date
2016-03-31
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, Driving, Behavior modification

Brief summary

There is clear, converging evidence from multiple prospective studies with well-diagnosed adolescents with ADHD and comparison, non-ADHD adolescents, that teen drivers with ADHD have more accidents and other adverse driving outcomes. Available research indicates parental monitoring and limit-setting for adolescent drivers is one of the most effective interventions for preventing negative driving outcomes. For children with ADHD, interventions to promote parenting capacity to effectively oversee and intervene in teen driving will likely need to be intensive and require multiple treatment components. The present proposal aims to compare the standard care for teen drivers (driver's education classes and driving practice) to the Supporting a Teen's Effective Entry to the Roadway (STEER) program, that includes a parent-teen intervention, adolescent skill building, parent training on effective adolescent management strategies, joint parent-teen negotiations sessions, practice on a driving simulator, parental monitoring of objective driving behaviors, and the targeting of safe teen driving via contingency management strategies (i.e., parent-teen contracts). To facilitate teen and parent engagement the intervention will be preceded by a motivational interview. The specific aims of the proposal are to investigate the efficacy of the STEER program relative to a standard care group in a randomized clinical trial (N=172) on measures of objective driving outcome and parenting capacity. It is hypothesized that the STEER program will result in improved outcomes relative to the standard care group at the end of intervention and 6 and 12 month follow-up assessments.

Interventions

DEVICECarChipPro

On board driving monitor

BEHAVIORALDriver's Education

10 Session License to Learn Program.

BEHAVIORALSTEER Program

8-session behavioral parent training and teen social skills/communication training program

OTHERDriving Simulator Practice

Practice Driving on a driving simulator

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Clinical Diagnosis of ADHD, Combined Type * At least 16 years old * Has a driving Permit

Exclusion criteria

* No parent willing to be involved * Seizure disorder, eating disorder, psychotic disorder, current diagnosis of substance/alcohol dependence * Prior Driver's education class

Design outcomes

Primary

MeasureTime frameDescription
Number of Risky Driving Events Assessed by On-Board Driving MonitorFollow 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.
Positive Parenting Observational DataFollow-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
86
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
86
Total172

Baseline characteristics

CharacteristicSTEER ProgramDriver TrainingTotal
Age, Categorical
<=18 years
86 Participants86 Participants172 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous16.98 years
STANDARD_DEVIATION 0.7
16.88 years
STANDARD_DEVIATION 0.65
16.92 years
STANDARD_DEVIATION 0.67
Region of Enrollment
United States
86 Participants86 Participants172 Participants
Sex: Female, Male
Female
23 Participants25 Participants48 Participants
Sex: Female, Male
Male
63 Participants61 Participants124 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 860 / 86
serious
Total, serious adverse events
0 / 860 / 86

Outcome results

Primary

Number of Risky Driving Events Assessed by On-Board Driving Monitor

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.

Time frame: Follow up period after the intervention (1 year)

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Driver TrainingNumber of Risky Driving Events Assessed by On-Board Driving Monitor3.20 eventsStandard Error 0.58
STEER ProgramNumber of Risky Driving Events Assessed by On-Board Driving Monitor3.95 eventsStandard Error 0.73
Primary

Positive Parenting Observational Data

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.

Time frame: Follow-up period after the intervention (12 weeks)

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Driver TrainingPositive Parenting Observational Data.46 score on a scaleStandard Error 0.01
STEER ProgramPositive Parenting Observational Data.44 score on a scaleStandard Error 0.01

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026