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

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ClinicalTrials.gov Identifier: NCT01322646
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Attention Deficit Hyperactivity Disorder Device: CarChipPro Behavioral: Driver's Education Behavioral: STEER Program Other: Driving Simulator Practice

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : July 2010
Primary Completion Date : June 2015
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Driver Training
Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
Device: CarChipPro
On board driving monitor
Behavioral: Driver's Education
10 Session License to Learn Program.
Other: Driving Simulator Practice
Practice Driving on a driving simulator
Experimental: STEER Program
Driver Education STEER Program
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

Outcome Measures

Primary Outcome Measures :
  1. On-board Driving Monitor [ Time Frame: Follow up period after the intervention (1 year) ]
  2. Observations of Parent-Teen Interaction [ Time Frame: Follow-up period after the intervention (1 year) ]
    Parents and teens will discuss two recent issues and these discussions will be coded using the a behavioral observation code.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322646

United States, New York
SUNY at Buffalo
Bufflo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
Principal Investigator: Gregory A Fabiano, PhD SUNY at Buffalo
More Information

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01322646     History of Changes
Other Study ID Numbers: HD058588
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: December 2015

Keywords provided by State University of New York at Buffalo:
Behavior modification

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms