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

Attention Deficit Hyperactivity Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322646
• Other study ID #: HD058588
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: March 2016

Study information

• Verified date: May 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Device:
• CarChipPro
On board driving monitor

Behavioral:
• Driver's Education
10 Session License to Learn Program.
• STEER Program
8-session behavioral parent training and teen social skills/communication training program

Other:
• Driving Simulator Practice
Practice Driving on a driving simulator

Locations

Country	Name	City	State
United States	SUNY at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fabiano GA, Schatz NK, Morris KL, Willoughby MT, Vujnovic RK, Hulme KF, Riordan J, Howard M, Hennessy D, Lewis K, Hawk L, Wylie A, Pelham WE. Efficacy of a family-focused intervention for young drivers with attention-deficit hyperactivity disorder. J Cons — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Risky Driving Events Assessed by On-Board Driving Monitor	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.	Follow up period after the intervention (1 year)
Primary	Positive Parenting Observational Data	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.	Follow-up period after the intervention (12 weeks)