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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
Scientific title
Evaluation of Mental Health First Aid (MHFA) training on transport workers
Secondary ID [1] 311448 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 332739 0
anxiety 333052 0
depression 333053 0
suicide intention 333054 0
Condition category
Condition code
Mental Health 329460 329460 0 0
Anxiety
Mental Health 329461 329461 0 0
Depression
Mental Health 329463 329463 0 0
Suicide

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327892 0
Prevention
Comparator / control treatment
Wait-list control group, who will receive the intervention after the 3 months evaluation on the intervention group is completed.
Control group
Active

Outcomes
Primary outcome [1] 337272 0
Recognition of mental health problems
Timepoint [1] 337272 0
Pre-training, immediate post-training, 3 months post-training.
Secondary outcome [1] 431283 0
Stigmatising attitude
Timepoint [1] 431283 0
Pre-training, immediate post-training and 3-months post-training

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
Allocation is not concealed.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/07/2022
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
200
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315728 0
Commercial sector/Industry
Name [1] 315728 0
Transport Workers Union
Country [1] 315728 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 317836 0
None
Name [1] 317836 0
Address [1] 317836 0
Country [1] 317836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314589 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 314589 0
Ethics committee country [1] 314589 0
Australia
Date submitted for ethics approval [1] 314589 0
04/04/2022
Approval date [1] 314589 0
11/05/2022
Ethics approval number [1] 314589 0
HRE2022-0236

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

Contacts
Principal investigator
Name 132110 0
Dr HuiJun Chih
Address 132110 0
Curtin University, Kent Street, Bentley, WA6102
Country 132110 0
Australia
Phone 132110 0
+61 892662139
Fax 132110 0
Email 132110 0
[email protected]
Contact person for public queries
Name 132111 0
HuiJun Chih
Address 132111 0
Curtin University, Kent Street, Bentley, WA6102
Country 132111 0
Australia
Phone 132111 0
+61 892662139
Fax 132111 0
Email 132111 0
[email protected]
Contact person for scientific queries
Name 132112 0
HuiJun Chih
Address 132112 0
Curtin University, Kent Street, Bentley, WA6102
Country 132112 0
Australia
Phone 132112 0
+61 892662139
Fax 132112 0
Email 132112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21548Study protocol  [email protected] To be submitted to a journal for publication.
21549Ethical 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.