Attention Deficit Hyperactivity DisorderNCT01322646
A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing CarChipPro, Driver's Education and STEER Program in people with Attention Deficit Hyperactivity Disorder, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- CarChipPro, Driver's Education and STEER Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical Diagnosis of ADHD, Combined Type
- At least 16 years old
- Has a driving Permit
Who cannot join
- No parent willing to be involved
- Seizure disorder, eating disorder, psychotic disorder, current diagnosis of substance/alcohol dependence
- Prior Driver's education class
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- CarChipPro, Driver's Education, STEER Program, Driving Simulator Practice
- Keywords
- ADHD, Driving, Behavior modification
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarChipProDevice
On board driving monitor
Driver's EducationBehavioural
10 Session License to Learn Program.
STEER ProgramBehavioural
8-session behavioral parent training and teen social skills/communication training program
Driving Simulator PracticeOther
Practice Driving on a driving simulator
| Study group | Role | What they receive |
|---|---|---|
| Driver Training | Active comparator | Driver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family Receives: Device: CarChipPro; Behavioral: Driver's Education; Other: Driving Simulator Practice |
| STEER Program | Experimental | Driver Education STEER Program Receives: Device: CarChipPro; Behavioral: Driver's Education; Behavioral: STEER Program; Other: Driving Simulator Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Follow-up period after the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionJun 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Fabiano, State University of New York at Buffalo
- Investigators
- Gregory A Fabiano, PhD, Principal investigator, SUNY at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322646
- Sponsor's protocol ID
- HD058588
- Status last verified
- May 2022
- First submitted
- 11 Aug 2010
- Last updated
- 11 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27618640
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01322646
- Acronym / sponsor ID
- HD058588
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Driving, Behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Posted 11 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driver Training | Active comparator | Device: CarChipPro, Behavioral: Driver's Education, Other: Driving Simulator PracticeDriver Education Program Practice driving on a driving simulator Provision of the CarChipPro to the family |
| STEER Program | Experimental | Device: CarChipPro, Behavioral: Driver's Education, Behavioral: STEER Program, Other: Driving Simulator PracticeDriver Education STEER Program |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical Diagnosis of ADHD, Combined Type
- At least 16 years old
- Has a driving Permit
Key exclusion criteria (3 listed)
- No parent willing to be involved
- Seizure disorder, eating disorder, psychotic disorder, current diagnosis of substance/alcohol dependence
- Prior Driver's education class
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarChipProOn board driving monitor | Device | Driver Training, STEER Program |
| Driver's Education10 Session License to Learn Program. | Behavioural | Driver Training, STEER Program |
| STEER Program8-session behavioral parent training and teen social skills/communication training program | Behavioural | STEER Program |
| Driving Simulator PracticePractice Driving on a driving simulator | Other | Driver Training, STEER Program |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27618640Fabiano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Fabiano, PhD principal investigator
SUNY at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CarChipPro, Driver's Education and STEER Program in people with Attention Deficit Hyperactivity Disorder, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Risky Driving Events Assessed by On-Board Driving Monitor (time frame: Follow up period after the intervention (1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.