Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001151426
Ethics application status
Approved
Date submitted
2/08/2016
Date registered
24/08/2016
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving independence in driving for people with Autism Spectrum Disorder
Scientific title
Effectiveness of an Autism Spectrum Disorder (ASD)-specific driver training package in supporting learner drivers with ASD to obtain a driver's license.
Secondary ID [1] 289751 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 299602 0
Condition category
Condition code
Neurological 299574 299574 0 0
Other neurological disorders
Mental Health 299898 299898 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the ASD-specific driver training package which includes face to face training, online training and on-road driving training. The intervention will be delivered by two driving instructors (WA and NSW) who will be trained by the project team. Parents in the intervention group will also be trained in the use of the ASD-specific training package prior to the commencement of the intervention.

This RCT study is the final stage of a big project. It is a three and a half year project. Contents for each proposed component are built from initial studies which involve literature review, focus group interviews and observation studies as follows:

Study 1: Scoping the literature and obtaining end-user and expert opinion:
- Summarise current knowledge on the driving behaviours of learner drivers with ASD.
- Identify and evaluate international and local resources that address the driving needs of people with ASD.
- Understand end-user and stakeholder perspectives on the difficulties learner drivers with ASD encounter while learning to drive; the driving behaviours they exhibit; and the strategies they use to support safe driving behaviours.
Study 2: Assess off- and on-road driving behaviours of learner drivers with ASD.
Study 3: Develop and pilot test the feasibility and appropriateness of a driver training package containing ASD-specific on- and off-road training sessions in supporting learner drivers with ASD to obtain a driver’s licence and maintain on-road safety.

The findings from these studies will be used to design and finalise the contents of the proposed components of the ASD-specific driver training package. We are currently conducting Study 1, therefore we are not able to provide any specific details for the proposed components. We hope to have the contents designed for each component by Dec 2017.
Intervention code [1] 295400 0
Other interventions
Comparator / control treatment
Control treatment is the conventional driver training.

The conventional driver training is the on-road driving training under a qualified supervisor. The learner drivers can use the driver's handbook provided by the Department of Transport (WA) or the Roads and Maritime Service (NSW) as a guide to safe driving.
Control group
Active

Outcomes
Primary outcome [1] 299048 0
The primary outcome measure is “pass or fail” of the practical driving test to provide an objective, un-biased estimate of the effectiveness of the package.

The driving test is the practical driving assessment conducted by the Department of Transport (WA) and the Roads and Maritime Services (NSW).
Timepoint [1] 299048 0
10 weeks after intervention commencement
Secondary outcome [1] 326007 0
The number of attempts to successfully pass the practical driving test. Participants to answer this in a survey form.
Timepoint [1] 326007 0
10 weeks after intervention commencement
Secondary outcome [2] 326540 0
Pre- and post-intervention Driving behaviour. Using assessment instrument such as The Performance Analysis of Driving Ability (P-Drive).
Timepoint [2] 326540 0
Baseline and 10 weeks after intervention commencement
Secondary outcome [3] 326541 0
Driving Behaviour post-intervention. Survey instrument such as the Manchester Driving Behaviour and the Adelaide Driving Self-Efficacy Scale will be used.
Timepoint [3] 326541 0
10-weeks after intervention commencement
Secondary outcome [4] 326542 0
Number of training lessons. Participants to answer in this in a survey form.
Timepoint [4] 326542 0
10-weeks after intervention commencement

Eligibility
Key inclusion criteria
To be eligible for the study, the participants have to be a learner driver aged 16 to 35 diagnosed with ASD who intend to learn driving, but have not started any formal driving training.
Minimum age
16 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who cannot speak and understand English, and cannot understand instructions will be excluded.

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)
Allocation concealment will be carried out using sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A set of sealed envelopes, each containing a treatment allocation (on the inside of the sealed envelope) and a study numbered representing sequence of enrolment (on the outside of the envelope), will be provided to the research officer in NSW and WA. After each new participant is checked for eligibility, provided consent to take part in the study, and has baseline measurements taken, they will be assigned a study number and the relevant envelope will be opened to reveal their allocated treatment. During the baseline assessment, both the researchers and participants will be blinded to group allocation. The sequences will be created using computer-generated random numbers (using the SAS version 9.2 software).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We employ the primary outcome measure, “pass or fail” of the driving test in each group to estimate the sample size. We assume that the study participants who are in the control group (driving instructor package) experience a 50% pass rate on their first attempt at the driving test. If we anticipate that those participants who undergo the additional pre-test training (the AS-Specific Training Package) will have a pass rate of 85%, then a sample of size N = 27 in each group will be adequate to detect this difference with 80% power and using a=0.05. The AS-specific training package are built up with reference to the requirements of licencing requirements of the Transportation Department, with special attention to the needs of AS-learner drivers. Expectation of the participants who has received the training to achieve a higher rate of passing is reasonable. We recruit 30 participant in each control and intervention group, taking into account of 10% estimated attrition rate.

The primary outcome measure is the “pass” or ‘fail” of the driving test, and this will be used to provide an objective, un-biased estimate of the effectiveness of the package. This outcome will be compared between the intervention and control groups using the Chi-square statistic. The secondary measures of the effectiveness of the training package include the number of attempts participants to successfully obtain a provisional licence (either a t-test or a non-parametric Wilcoxon 2-sample test), number of training lessons (t-test or Wilcoxon) and changes in driving performance score after training. The changes in the driving performance score for will be calculated for each participant (post minus pre scores). These changes in scores will then be compared between the intervention and control groups using either a t-test or Wilcoxon test (depending on skewness). A t-test or Wilcoxon test will also be used to determine the statistical significance of difference between intervention and control groups in the post-test measure outcomes including the Manchester Driving Behaviour and the Adelaide Driving Self-Efficacy Scale.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2018
Actual
11/09/2018
Date of last participant enrolment
Anticipated
31/03/2019
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
60
Accrual to date
44
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 294198 0
Government body
Name [1] 294198 0
Autism CRC Limited
Country [1] 294198 0
Australia
Primary sponsor type
Individual
Name
Hoe Lee
Address
Associate Professor Hoe Lee
Curtin University
GPO Box U1987
Perth Western Australia
6845
Country
Australia
Secondary sponsor category [1] 293028 0
None
Name [1] 293028 0
None
Address [1] 293028 0
None
Country [1] 293028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295602 0
Curtin Human Research Ethics
Ethics committee address [1] 295602 0
Ethics committee country [1] 295602 0
Australia
Date submitted for ethics approval [1] 295602 0
19/04/2016
Approval date [1] 295602 0
15/07/2016
Ethics approval number [1] 295602 0
HRE2016-0130
Ethics committee name [2] 295604 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [2] 295604 0
Ethics committee country [2] 295604 0
Australia
Date submitted for ethics approval [2] 295604 0
19/07/2016
Approval date [2] 295604 0
20/07/2016
Ethics approval number [2] 295604 0
RH11772

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 983 983 0 0
/AnzctrAttachments/371154-20160715 Driving Curtin HREC Approved.pdf
Attachments [2] 984 984 0 0
/AnzctrAttachments/371154-H11772 - UWS_Driving Human Ethics Reciprocal Approval - Jul 2016.pdf
Attachments [3] 985 985 0 0
/AnzctrAttachments/371154-20160801 Driving_Proposal_RCT Registration.docx

Contacts
Principal investigator
Name 67674 0
A/Prof Hoe Lee
Address 67674 0
Curtin University
GPO Box U1987
Perth
Western Australia
6845
Country 67674 0
Australia
Phone 67674 0
+618 9266 4652
Fax 67674 0
+618 9266 3636
Email 67674 0
[email protected]
Contact person for public queries
Name 67675 0
Hoe Lee
Address 67675 0
Curtin University
GPO Box U1987
Perth
Western Australia
6845
Country 67675 0
Australia
Phone 67675 0
+618 9266 4652
Fax 67675 0
+618 9266 3636
Email 67675 0
[email protected]
Contact person for scientific queries
Name 67676 0
Hoe Lee
Address 67676 0
Curtin University
GPO Box U1987
Perth
Western Australia
6845
Country 67676 0
Australia
Phone 67676 0
+618 9266 4652
Fax 67676 0
+618 9266 3636
Email 67676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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.