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

This study is currently recruiting participants.
Verified June 2012 by State University of New York at Buffalo
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01322646
First received: August 11, 2010
Last updated: June 5, 2012
Last verified: June 2012
History of Changes

August 11, 2010
June 5, 2012
July 2010
April 2015   (final data collection date for primary outcome measure)
  • On-board Driving Monitor [ Time Frame: Follow up period after the intervention (1 year) ] [ Designated as safety issue: No ]
  • Observations of Parent-Teen Interaction [ Time Frame: Follow-up period after the intervention (1 year) ] [ Designated as safety issue: No ]
    Parents and teens will discuss two recent issues and these discussions will be coded using the a behavioral observation code.
Same as current
Complete list of historical versions of study NCT01322646 on ClinicalTrials.gov Archive Site
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A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
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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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Attention Deficit Hyperactivity Disorder
  • Device: CarChipPro
    On board driving monitor
  • Behavioral: Driver's Education
    10 Session License to Learn Program.
  • Behavioral: STEER Program
    8-session behavioral parent training and teen social skills/communication training program
  • Other: Driving Simulator Practice
    Practice Driving on a driving simulator
  • Active Comparator: Driver Training
    Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
    Interventions:
    • Device: CarChipPro
    • Behavioral: Driver's Education
    • Other: Driving Simulator Practice
  • Experimental: STEER Program
    Driver Education STEER Program
    Interventions:
    • Device: CarChipPro
    • Behavioral: Driver's Education
    • Behavioral: STEER Program
    • Other: Driving Simulator Practice
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
172
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April 2015   (final data collection date for primary outcome measure)

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
Both
16 Years to 18 Years
No
Contact: Gregory A Fabiano, PhD 716-645-1130 fabiano@buffalo.edu
United States
 
NCT01322646
HD058588
No
State University of New York at Buffalo
State University of New York at Buffalo
Not Provided
Principal Investigator: Gregory A Fabiano, PhD SUNY at Buffalo
State University of New York at Buffalo
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP