Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001232820
Ethics application status
Approved
Date submitted
21/11/2012
Date registered
21/11/2012
Date last updated
3/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
P Drivers Project: the effects of a Driver Safety Behaviour Change Program on novice drivers
Scientific title
P1 drivers’ change in crashes, infringements and self-reported driving behaviours following a Driver Safety Behaviour Change Program
Secondary ID [1] 281569 0
None
Universal Trial Number (UTN)
Trial acronym
PDP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crashes, infringements and self-reported driving behaviours among young novice drivers 287853 0
Condition category
Condition code
Injuries and Accidents 288209 288209 0 0
Other injuries and accidents
Public Health 288210 288210 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Driver Safety Behaviour Change Program – a driver safety behaviour change program consisting of an online self-assessment of driving risk questionnaire, a group session regarding driving patterns and behaviour (known as group session 1), an on-road coaching session, and a final group session regarding driving patterns and behaviour (known as group session 2). The self-assessment questionnaire takes approximately 20 minutes to complete, both group session 1 and group session 2 take 3 hours, and the on-road coaching session takes 2 hours. The timings between each course session are as follows: the self-assessment questionnaire is completed within 0-14 days of the participant attending group session 1, the on-road coaching session is completed 7 days after group session 1, and group session 2 is completed within 14 days of attending the on-road coaching session. All group sessions and on-road coaching sessions are facilitated by trained instructors who are employed by the Centre for Adult Education (CAE). The CAE are contracted to VicRoads to deliver the training program in Victoria and NSW. The intervention is being undertaken with new drivers in Victoria (randomised control trial (RCT)/Quantitative Trial) and new drivers in New South Wales (NSW) (Process Trial). There are no differences in the intervention between Victoria and New South Wales participants – there are no control participants recruited in New South Wales.
Intervention code [1] 286091 0
Prevention
Intervention code [2] 286092 0
Behaviour
Intervention code [3] 286093 0
Lifestyle
Comparator / control treatment
Control group is active, they are asked to complete three surveys which are completed at the same time as the Treatment participants. The survey timings are: pre-program (between 30-90 days after obtaining P1 licence), 1-month post-program, and 12-months post-program. The surveys take ~20 minutes to complete and are all administered online. The surveys cover the following areas: Self-reported crashes, self-reported driving exposure, driving behaviour (based on Driver Behaviour Questionnaire), driving style (based on 11 items using visual analogue scales), awareness of accident risk factors (5 items out of a possible 22 items are selected as the factors that are most important in causing serious accidents – this question is repeated using the same 22 items for the least important factors), and the key ingredients for behaviour change are measured via self-efficacy, outcome expectancies, subjective norms, and intentions The control group is only relevant for the Victorian trial, that is in New South Wales only Treatment participants are recruited because the New South Wales sample of participants are evaluated via the Process Evaluation whereas the Victorian participants are evaluated via the Quantitative Evaluation.
Control group
Active

Outcomes
Primary outcome [1] 288402 0
Police-reported and self-reported crashes as assessed by data linkage to VicRoads crash database and participant's self-report crashes (which are measured in the three online surveys)
Timepoint [1] 288402 0
Baseline, 1-month post-intervention, and 12-months post-intervention
Secondary outcome [1] 300056 0
Self-reported safe and unsafe driving behaviour, which are measured in the three online surveys
Timepoint [1] 300056 0
Baseline, 1-month post-intervention, and 12-months post-intervention
Secondary outcome [2] 300057 0
Participant's awareness of factors that influence their risk of crash involvement, which are measured in the three online surveys
Timepoint [2] 300057 0
Baseline, 1-month post-intervention, and 12-months post-intervention
Secondary outcome [3] 300058 0
Self-reported traffic offences and compliance with licence conditions and restrictions, which are measured in the three online surveys.
Timepoint [3] 300058 0
Baseline, 1-month post-intervention, and 12-months post-intervention
Secondary outcome [4] 300059 0
Police-reported traffic offences assessed by data linkage to the VicRoads Driver Licensing System (DLS) database
Timepoint [4] 300059 0
Baseline, 1-month post-intervention, and 12-months post-intervention
Secondary outcome [5] 300065 0
Practical issues that may need to be resolved in order to implement a nationwide Program for young novice drivers. This outcome relates to the Process Evaluation and is measured by providing participants in NSW feedback surveys at the end of each course session and by inviting sub-sample of Treatment participants in NSW and in Victoria to attend focus groups 1-month post-intervention
Timepoint [5] 300065 0
During intervention, and 1-month post-intervention

Eligibility
Key inclusion criteria
Victorian P-plate drivers aged between 18 and 22 years/NSW P-plate drivers aged between 17 and 21 years at the time of recruitment and in the first four months of licensing. The exclusion criteria are inability to read or write in English, and non-resident of Victoria/NSW for the RCT and process trials respectively. This will be assessed by asking questions at commencement and through the Sign-Up Survey.
Minimum age
17 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to read or write in English, and non-resident of Victoria or NSW. This will be assessed by asking questions at commencement and through the Sign-Up Survey.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer for all Victorian participants (this is applicable to Victorian participants only as NSW are all allocated to the Treatment arm for Process Evaluation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286358 0
Government body
Name [1] 286358 0
VicRoads
Country [1] 286358 0
Australia
Funding source category [2] 286359 0
Government body
Name [2] 286359 0
The Transport Accident Commission
Country [2] 286359 0
Australia
Funding source category [3] 286360 0
Government body
Name [3] 286360 0
Federal Government - Department of Infrastructure and Transport
Country [3] 286360 0
Australia
Funding source category [4] 286361 0
Government body
Name [4] 286361 0
Transport for NSW
Country [4] 286361 0
Australia
Funding source category [5] 286362 0
Commercial sector/Industry
Name [5] 286362 0
Federal Chamber of Automotive Industries
Country [5] 286362 0
Australia
Funding source category [6] 286363 0
Commercial sector/Industry
Name [6] 286363 0
Royal Automobile Club of Victoria (RACV)
Country [6] 286363 0
Australia
Funding source category [7] 286364 0
Commercial sector/Industry
Name [7] 286364 0
NRMA Insurance
Country [7] 286364 0
Australia
Primary sponsor type
Government body
Name
VicRoads
Address
VicRoads
60 Denmark Street
Kew, Victoria, 3101
Country
Australia
Secondary sponsor category [1] 285145 0
University
Name [1] 285145 0
Monash University
Address [1] 285145 0
C/O Professor Rod McClure
Monash Injury Research Institute
Boilerhouse Road,
Building 70, Monash University
Clayton, Victoria, 3800
Country [1] 285145 0
Australia
Other collaborator category [1] 277192 0
University
Name [1] 277192 0
University of New South Wales
Address [1] 277192 0
C/O Dr Julie Hatfield
Transport and Road Safety Research Centre (TARS)
College Road,
Level 1, West Wing
Old Main Building
University of New South Wales
Sydney, NSW 2052
Country [1] 277192 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288438 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 288438 0
Ethics committee country [1] 288438 0
Australia
Date submitted for ethics approval [1] 288438 0
21/01/2011
Approval date [1] 288438 0
21/01/2011
Ethics approval number [1] 288438 0
CF10/2986 - 2010001630
Ethics committee name [2] 288439 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [2] 288439 0
Ethics committee country [2] 288439 0
Australia
Date submitted for ethics approval [2] 288439 0
01/05/2011
Approval date [2] 288439 0
01/05/2011
Ethics approval number [2] 288439 0
11133

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34971 0
Address 34971 0
Country 34971 0
Phone 34971 0
Fax 34971 0
Email 34971 0
Contact person for public queries
Name 18218 0
Robyn Seymour
Address 18218 0
Manager P Drivers Project
Level 3, 60 Denmark Street
Kew 3101
Victoria
Country 18218 0
Australia
Phone 18218 0
+613 9093 1490
Fax 18218 0
Email 18218 0
[email protected]
Contact person for scientific queries
Name 9146 0
Professor Rod McClure
Address 9146 0
Monash Injury Research Institute
Boilerhouse Road
Building 70,
Monash University,
Clayton, Victoria, 3800
Country 9146 0
Australia
Phone 9146 0
+613 9905 4372
Fax 9146 0
Email 9146 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.