A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CarChipPro
Driver's Education
STEER Program
Driving Simulator Practice
Sponsored by
About this trial
This is an interventional prevention trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Driving, Behavior modification
Eligibility 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
Sites / Locations
- SUNY at Buffalo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Driver Training
STEER Program
Arm Description
Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
Driver Education STEER Program
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01322646
First Posted
August 11, 2010
Last Updated
May 9, 2022
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT01322646
Brief Title
A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Driving, Behavior modification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Driver Training
Arm Type
Active Comparator
Arm Description
Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family
Arm Title
STEER Program
Arm Type
Experimental
Arm Description
Driver Education STEER Program
Intervention Type
Device
Intervention Name(s)
CarChipPro
Intervention Description
On board driving monitor
Intervention Type
Behavioral
Intervention Name(s)
Driver's Education
Intervention Description
10 Session License to Learn Program.
Intervention Type
Behavioral
Intervention Name(s)
STEER Program
Intervention Description
8-session behavioral parent training and teen social skills/communication training program
Intervention Type
Other
Intervention Name(s)
Driving Simulator Practice
Intervention Description
Practice Driving on a driving simulator
Primary Outcome Measure Information:
Title
Number of Risky Driving Events Assessed by On-Board Driving Monitor
Description
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.
Time Frame
Follow up period after the intervention (1 year)
Title
Positive Parenting Observational Data
Description
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.
Time Frame
Follow-up period after the intervention (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Fabiano, PhD
Organizational Affiliation
SUNY at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27618640
Citation
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.
Results Reference
result
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A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
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