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Trial registered on ANZCTR


Registration number
ACTRN12612000718842
Ethics application status
Approved
Date submitted
28/06/2012
Date registered
5/07/2012
Date last updated
18/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a computer training intervention for novice drivers with Attention Deficit Hyperactivity Disorder or Autism Spectrum Disorder: pilot randomized controlled trial.
Scientific title
PC-based CD-ROM interactive training program entitled Drive Smart, to improve the Hazard Perception Skills of young drivers with either Attention-Deficit/Hyperactivity Disorder or Autism Spectrum disorder. Pilot randomized controlled trial
Secondary ID [1] 280734 0
Nil
Universal Trial Number (UTN)
U1111-1132-1182
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit hyperactivity disorder (ADHD) 286783 0
Autism Spectrum Disorder (ASD) 294540 0
Condition category
Condition code
Human Genetics and Inherited Disorders 287115 287115 0 0
Other human genetics and inherited disorders
Mental Health 287148 287148 0 0
Other mental health disorders
Mental Health 294849 294849 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both the experimental group and the control will receive one module of a PC-based CD-ROM interactive training product entitled Drive Smart. This is made possible by introducing a second phase in which the control group will receive Drive Smart training as a delayed intervention immediately after receiving the control condition. Participants initially allocated to the control group will now receive Drive Smart training as a delayed intervention and will receive an additional assessment following training (4 assessment time points in total). Follow-up will be 6-weeks for all participants. All participants will be asked to complete one module of Drive Smart training (approximately 60 mins, completed on a single occasion). Drive Smart combines groups of exercises with scripted video sequences shot of every day driving scenes. The video sequences combine views through the front windscreen of a car, internal mirror and driver's side external door mirror. Multiple intervention concepts are embedded in the content of Drive Smart such as insight training (the process of increasing driver awareness of skill limitations) and commentary driving. Commentary driving is a technique used in police driver training where the driver gives a running verbal commentary. The commentary combines information about what the driver can see, is thinking and what they are planning to do.
Intervention code [1] 285179 0
Behaviour
Intervention code [2] 285204 0
Prevention
Comparator / control treatment
The control group will view a documentary video about the history of the motor car. Running time approximately 60 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 287439 0
The primary outcome of this study will be improved hazard perception response time of participants as measured by a computer-based Hazard Perception Test (HPT) (Marrington, Horswill, & Wood, 2008; Smith, Horswill, Chambers, & Wetton, 2009; Wetton, Hill, & Horswill, 2011). The test involves participants watching a short instructional video followed by a selection of short authentic traffic video clips. The clips depict potential hazards such as pedestrians stepping out into the roadway and are filmed from a real car driver's perspective. Selected clips will be randomly assigned to each HPT. The back end of the test is coded to measure hazard response latency by recording the location and timing of mouse clicks and converting earliest responses to potential traffic conflicts into a reaction time score. The final score is the mean latency score across all test items. Evaluation of The HPT's psychometric properties demonstrates good internal consistency, with a Cronbach's alpha coefficient reported of 0.93 (Wetton, et al., 2011).
Timepoint [1] 287439 0
Experimental group (group A) time points: 0 (baseline), 1 (2 hours), 2 (6 weeks).

Control group (group B) time points: 0 (baseline), 1 (2 hours), 3 (3 hours), 4 (6 weeks).
Secondary outcome [1] 298149 0
Risk perception will be assessed using a computer based test entitled Occupational Therapy Risk Perception Test (OT-RiPT). Participants will be assessed individually in a quiet room. Participants are asked to sit in front of a computer screen and watch a video recorded from a driver’s perspective of real driving. The view is of the road ahead. Participants will be asked to evaluate how risky they think the situation is using a visual analogue scale. The test takes approximately15 minutes to complete.
Timepoint [1] 298149 0
Experimental group (group A) time points: 0 (baseline), 1 (2 hours), 2 (6 weeks).

Control group (group B) time points: 0 (baseline), 1 (2 hours), 3 (3 hours), 4 (6 weeks).
Secondary outcome [2] 298150 0
Brake reaction time will be tested using the RT-2S Simple Reaction Time Tester (Advanced Therapy Products Inc, 2008). The RT-2S is comprised of a test light box, foot pedal module and operator control box. Subjects sit in front of the test light box and adjust their sitting position to achieve good access to the foot pedal module. Subjects are instructed to accelerate by pressing the accelerator pedal until the green light on the test light box is illuminated. The subject is instructed to press the brake pedal as soon as the red light comes on. The red light is randomly controlled from the operator control box. One practice test is given followed by 3 trials. The 3 trial scores are summed and the mean calculated.
Timepoint [2] 298150 0
Experimental group (group A) time points: 0 (baseline), 1 (2 hours), 2 (6 weeks).

Control group (group B) time points: 0 (baseline), 1 (2 hours), 3 (3 hours), 4 (6 weeks).

Eligibility
Key inclusion criteria
Eligible participants will be English speaking and aged 16 to 25 years. Participants will be required to meet diagnostic criteria for ADHD or ASD and this will be confirmed by a doctor's letter. Participants will be required to have participated in some driver training. Participants are excluded if they have had previous experience using a computer based driver training program.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be done using Excel at La Trobe University, Melbourne.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised once consent has been obtained and all baseline measures have been collected. Randomisation is done in Excel. Allocations have been placed in sealed, opaque sequentially numbered envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2014
Actual
20/08/2014
Date of last participant enrolment
Anticipated
Actual
11/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment postcode(s) [1] 5454 0
3086
Recruitment postcode(s) [2] 5455 0
3085
Recruitment postcode(s) [3] 5456 0
3088
Recruitment postcode(s) [4] 5457 0
3094
Recruitment postcode(s) [5] 5458 0
3095
Recruitment postcode(s) [6] 5459 0
3072
Recruitment postcode(s) [7] 5460 0
3073
Recruitment postcode(s) [8] 5461 0
3071
Recruitment postcode(s) [9] 5462 0
3075
Recruitment postcode(s) [10] 9388 0
4558 - Maroochydore
Recruitment postcode(s) [11] 9389 0
2000 - Sydney
Recruitment postcode(s) [12] 9390 0
3181 - Prahran
Recruitment postcode(s) [13] 9391 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 285540 0
University
Name [1] 285540 0
La Trobe University
Country [1] 285540 0
Australia
Primary sponsor type
Individual
Name
Chris Bruce
Address
Occupational Therapy, Community & Clinical Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC 3086
Country
Australia
Secondary sponsor category [1] 284379 0
Individual
Name [1] 284379 0
Professor Leeanne Carey
Address [1] 284379 0
Occupational Therapy, Community & Clinical Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC 3086
Country [1] 284379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287560 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 287560 0
Research Services
La Trobe University
Melbourne
Victoria 3086
Ethics committee country [1] 287560 0
Australia
Date submitted for ethics approval [1] 287560 0
09/07/2012
Approval date [1] 287560 0
03/12/2013
Ethics approval number [1] 287560 0
12-092 mod 1

Summary
Brief summary
There is good quality evidence that a link exists between negative driving outcomes and ADHD, yet reducing crash and traffic infringement risk for this group of drivers remains problematic. The pilot study aims are to:
1) Determine the magnitude of the between-group and within-subject change in hazard perception skills, reaction time and risk-taking propensity in young drivers with ADHD or ASD exposed to Drive Smart training.
2) Determine if any between-group or within-subject change in hazard perception, risk-taking propensity or reaction time is maintained over time.
3) Estimate the variance of the primary outcome variable to enable sample size calculation.
4) Determine the rate of recruitment and retention of participants in order to establish if a full-scale evaluation of Drive Smart is feasible.
Young drivers aged between 16 and 25 years will be randomised to an intervention or control group. Participants in the intervention group will receive a computer training session using a PC-based CD-ROM interactive training program. A second phase is included, in which the control group will receive Drive Smart training as a delayed intervention. This is intended to maximise resources and data collection within the reduced number of participants recruited. This will facilitate investigation of the potential benefits of Drive Smart training beyond the current exposure with participants acting as their own control. An additional benefit of including a second phase is that all participants receive the intervention. This research will contribute to the evidence-base regarding the efficacy of interventions for improving the hazard perception skills of young novice drivers.
Trial website
https://drivingsafeblog.wordpress.com/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34363 0
Prof Leeanne Carey
Address 34363 0
Occupational Therapy, Community & Clinical Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC 3086
Country 34363 0
Australia
Phone 34363 0
61 3 94795600
Fax 34363 0
Email 34363 0
[email protected]
Contact person for public queries
Name 17610 0
Chris Bruce
Address 17610 0
Occupational Therapy, Community & Clinical Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC 3086
Country 17610 0
Australia
Phone 17610 0
61 3 94795699
Fax 17610 0
61 3 94795737
Email 17610 0
[email protected]
Contact person for scientific queries
Name 8538 0
Chris Bruce
Address 8538 0
Occupational Therapy, Community & Clinical Allied Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC 3086
Country 8538 0
Australia
Phone 8538 0
61 3 94795699
Fax 8538 0
61 3 94795737
Email 8538 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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