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Trial registered on ANZCTR
Registration number
ACTRN12624000323527
Ethics application status
Approved
Date submitted
31/01/2024
Date registered
25/03/2024
Date last updated
25/03/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Mental Health First Aid (MHFA) training and transport workers
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Scientific title
Evaluation of Mental Health First Aid (MHFA) training on transport workers
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Secondary ID [1]
311448
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
mental health
332739
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anxiety
333052
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depression
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suicide intention
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Condition category
Condition code
Mental Health
329460
329460
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0
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Anxiety
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Mental Health
329461
329461
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0
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Depression
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Mental Health
329463
329463
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0
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Suicide
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is the training of Mental Health First Aid (MHFA) program. Informational materials and activities used will include the standard MHFA manual (written by Betty Kitchener, Anthony Jorm and Claire Kelly, which covers "Introduction to Mental Health Problems and MHFA", "First Aid for Developing Mental Health Problems" (including anxiety, depression, psychosis, substance use problems, gambling problems, eating disorders) and "First Aid for Mental Health Crises" (including suicidal thoughts and behaviours, non-suicidal self-injury, panic attacks, traumatic event, severe psychotic states, severe effects from alcohol and drug use, aggressive behaviours). The manual includes statistics of various mental illnesses and strategies (e.g. mental health plan, resources for help seeking) that the participants will be introduced to by the MHFA trainer. There will also be MHFA videos that cover role-play scenarios (played by professional actors) of various mental health conditions, and other role-play activities that the participants can act on with their peers during the training session. The training session will be delivered by accredited MHFA trainer in person (face-to-face mode) for 12 hours over a 2-day period (6 hours/day). The 2-day intervention will be delivered once to the participants on site, either at the TWU branch offices or the participating companies, in a small group setting (<15 people in a room). Having the accredited MHFA trainer delivering the intervention helps to maintain adherence and fidelity to the intervention.
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Intervention code [1]
327892
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Prevention
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Comparator / control treatment
Wait-list control group, who will receive the intervention after the 3 months evaluation on the intervention group is completed.
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Control group
Active
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Outcomes
Primary outcome [1]
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Recognition of mental health problems
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Assessment method [1]
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Validated Mental Health First Aid (MHFA) vignette from previous study (DOI: 10.1186/1471-244X-4-23)
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Timepoint [1]
337272
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Pre-training, immediate post-training, 3 months post-training.
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Secondary outcome [1]
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Stigmatising attitude
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Assessment method [1]
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Validated MHFA vignette from previous study (DOI:10.1186/1471-244X-4-23)
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Timepoint [1]
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Pre-training, immediate post-training and 3-months post-training
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Eligibility
Key inclusion criteria
(i) staff aged above 18 years old,
(ii) staff who have not previously completed the MHFA training,
(iii) staff who are currently employed and
(iv) staff who have access to a device that can be connected to the internet to complete the baseline and post-training surveys.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling where the TWU study coordinator selects participants into the intervention group or the wait-list control group.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
5/07/2022
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
30/06/2026
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Actual
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Sample size
Target
200
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Accrual to date
29
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Transport Workers Union
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Address [1]
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Country [1]
315728
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
317836
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Country [1]
317836
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Curtin University Human Research Ethics Committee
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Ethics committee address [1]
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GPO Box U1987 Perth, Western Australia 6845, Australia.
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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04/04/2022
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Approval date [1]
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11/05/2022
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Ethics approval number [1]
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HRE2022-0236
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Summary
Brief summary
The study will evaluate the impact of MHFA training on the workers' ability to recognise mental health problems and stigmatising attitudes, along with their shared stories about their confidence in having conversations about mental health issues and perceptions of the value of MHFA training. It is hypothesised that the prevalence of workers who can recognise mental health problems immediately after the training is 5% more than those who were not trained, and such ability to recognise mental health problems remains after 3 months of the MHFA training.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr HuiJun Chih
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Address
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Curtin University, Kent Street, Bentley, WA6102
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Country
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Australia
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Phone
132110
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+61 892662139
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Fax
132110
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Email
132110
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[email protected]
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Contact person for public queries
Name
132111
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HuiJun Chih
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Address
132111
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Curtin University, Kent Street, Bentley, WA6102
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Country
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Australia
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Phone
132111
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+61 892662139
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Fax
132111
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Email
132111
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[email protected]
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Contact person for scientific queries
Name
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HuiJun Chih
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Address
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Curtin University, Kent Street, Bentley, WA6102
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Country
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Australia
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Phone
132112
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+61 892662139
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Fax
132112
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Email
132112
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The datasets generated and/or analysed during the current study are not publicly available due to privacy of the participants and their companies but aggregated data are available from the corresponding author on reasonable request.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21548
Study protocol
[email protected]
To be submitted to a journal for publication.
21549
Ethical approval
[email protected]
Approval number: HRE2022-0236
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.
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