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Clinical Trials/NCT01322646
NCT01322646CompletedNot Applicable

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

State University of New York at Buffalo1 site in 1 country172 target enrollmentStarted: July 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
172
Locations
1
Primary Endpoint
Number of Risky Driving Events Assessed by On-Board Driving Monitor

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
16 Years to 18 Years (Child, Adult)
Sex
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

Arms & Interventions

Driver Training

Active Comparator

Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family

Intervention: CarChipPro (Device)

Driver Training

Active Comparator

Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family

Intervention: Driver's Education (Behavioral)

Driver Training

Active Comparator

Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family

Intervention: Driving Simulator Practice (Other)

STEER Program

Experimental

Driver Education STEER Program

Intervention: CarChipPro (Device)

STEER Program

Experimental

Driver Education STEER Program

Intervention: Driver's Education (Behavioral)

STEER Program

Experimental

Driver Education STEER Program

Intervention: STEER Program (Behavioral)

STEER Program

Experimental

Driver Education STEER Program

Intervention: Driving Simulator Practice (Other)

Outcomes

Primary Outcomes

Number of Risky Driving Events Assessed by On-Board Driving Monitor

Time Frame: Follow up period after the intervention (1 year)

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.

Positive Parenting Observational Data

Time Frame: Follow-up period after the intervention (12 weeks)

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gregory Fabiano

Principal Investigator

State University of New York at Buffalo

Study Sites (1)

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