NCT01322646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

May 11, 2022

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

4.9 years

First QC Date

August 11, 2010

Results QC Date

November 14, 2018

Last Update Submit

May 9, 2022

Conditions

Keywords

ADHDDrivingBehavior modification

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

Driver Training

ACTIVE COMPARATOR

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

Device: CarChipProBehavioral: Driver's EducationOther: Driving Simulator Practice

STEER Program

EXPERIMENTAL

Driver Education STEER Program

Device: CarChipProBehavioral: Driver's EducationBehavioral: STEER ProgramOther: Driving Simulator Practice

Interventions

On board driving monitor

Driver TrainingSTEER Program

10 Session License to Learn Program.

Driver TrainingSTEER Program
STEER ProgramBEHAVIORAL

8-session behavioral parent training and teen social skills/communication training program

STEER Program

Practice Driving on a driving simulator

Driver TrainingSTEER Program

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical Diagnosis of ADHD, Combined Type
  • At least 16 years old
  • Has a driving Permit

You may not qualify if:

  • No parent willing to be involved
  • Seizure disorder, eating disorder, psychotic disorder, current diagnosis of substance/alcohol dependence
  • Prior Driver's education class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY at Buffalo

Buffalo, New York, 14214, United States

Location

Related 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 Consult Clin Psychol. 2016 Dec;84(12):1078-1093. doi: 10.1037/ccp0000137. Epub 2016 Sep 12.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Gregory A. Fabiano, Ph.D.
Organization
University at Buffalo

Study Officials

  • Gregory A Fabiano, PhD

    SUNY at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2010

First Posted

March 24, 2011

Study Start

July 1, 2010

Primary Completion

June 1, 2015

Study Completion

March 1, 2016

Last Updated

May 11, 2022

Results First Posted

May 11, 2022

Record last verified: 2022-05

Locations