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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Device: CarChipPro
Behavioral: Driver's Education
Behavioral: STEER Program
Other: Driving Simulator Practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 172
Study Start Date: July 2010
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322646

Contacts
Contact: Gregory A Fabiano, PhD 716-645-1130 fabiano@buffalo.edu

Locations
United States, New York
SUNY at Buffalo Recruiting
Bufflo, New York, United States, 14214
Contact: Gregory A Fabiano, PhD    716-829-2244 ext 122    fabiano@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Gregory A Fabiano, PhD SUNY at Buffalo
  More Information

No publications provided

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01322646     History of Changes
Other Study ID Numbers: HD058588
Study First Received: August 11, 2010
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Disease
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014