A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
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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 |
- 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 |
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| Contact: Gregory A Fabiano, PhD | 716-645-1130 | fabiano@buffalo.edu |
| 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 | |
| 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:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013