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

Study Overview
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Brief Summary
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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.

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Device: CarChipPro
* Behavioral: Driver's Education
* Behavioral: STEER Program
* Other: Driving Simulator Practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Driver Training<br>Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family | Device: CarChipPro<br>* On board driving monitor<br>Behavioral: Driver's Education<br>* 10 Session License to Learn Program.<br>Other: Driving Simulator Practice<br>* Practice Driving on a driving simulator<br>|
| Experimental: STEER Program<br>Driver Education STEER Program | Device: CarChipPro<br>* On board driving monitor<br>Behavioral: Driver's Education<br>* 10 Session License to Learn Program.<br>Behavioral: STEER Program<br>* 8-session behavioral parent training and teen social skills/communication training program<br>Other: Driving Simulator Practice<br>* Practice Driving on a driving simulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Follow up period after the intervention (1 year) | 
| 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. | Follow-up period after the intervention (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Driving, Behavior modification