Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000756820
Ethics application status
Approved
Date submitted
22/04/2021
Date registered
16/06/2021
Date last updated
28/07/2024
Date data sharing statement initially provided
16/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Conversations about Suicide in Australian Men's Sheds
Scientific title
Effect of the Mental Health First Aid Conversations about Suicide course on intentions to assist a person at risk of suicide in Australian Men's Sheds: A cluster randomised controlled trial
Secondary ID [1] 303539 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 320886 0
Condition category
Condition code
Mental Health 318701 318701 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mental Health First Aid Conversations about Suicide (MHFA-CaS) course is a specialised four-hour course that teaches community members to recognise when someone is experiencing suicidal thoughts and provide them with appropriate support. Participants will learn how to identify warning signs for suicide, support a person in crisis, help a person at risk of suicide stay safe and connect someone to appropriate professional help. The curriculum has been developed by MHFA and is based on guidelines developed through the expert consensus of people with lived experience of mental health problems and professionals. The course will include the use of a handbook, PowerPoint slides, videos and offers role-play to practice help giving. The course will be delivered in Men’s Sheds by instructors who are trained and accredited by MHFA Australia. It will be offered to approximately 15 participants per course group by online videoconferencing or face to face, depending on the preference of the local Men’s Shed coordinator and Shed members. The face to face courses will be delivered at a suitable location within the local community, e.g. the Men’s Shed or neighbourhood house. Each Men’s Shed cluster will be offered one or two MHFA-CaS courses depending on the number of enrolments. The intervention group will receive the course between July 2021 and June 2023. The waitlist control group will receive the course between February 2022 and January 2024. There will be minor adaptations to the course to make it more suitable for older men. This will include tailoring of scenarios and the artwork to include male peers.
Intervention code [1] 319822 0
Prevention
Intervention code [2] 320599 0
Behaviour
Comparator / control treatment
Waitlist control. The control group will receive the intervention after a waiting period of 7 months, during which registered participants will be asked to fill in three surveys at similar time intervals as the intervention group (baseline, 1 month and 7 months after baseline).
Control group
Active

Outcomes
Primary outcome [1] 326635 0
Change in intentions to assist a person who is at risk of suicide in response to a vignette used in previous studies (Jorm et al, 2018; Nicholas et al, 2020). Participants will be asked to indicate their likelihood of undertaking 15 helping actions.

Jorm, A.F., et al., Associations of training to assist a suicidal person with subsequent quality of support: results from a national survey of the Australian public. BMC psychiatry, 2018. 18(1): p. 1-7.
Nicholas, A., et al., Confidence and intentions to help a person at risk of suicide. Suicide Life-Threatening Behavior, 2020. 50(1): p. 138-150.
Timepoint [1] 326635 0
Baseline (pre-intervention) and 1 month (post-intervention) and 7 months after baseline (follow-up, primary endpoint)
Secondary outcome [1] 392216 0
Changes in helping actions taken to assist a person who is at risk of suicide (based on Jorm et al, 2018; Nicholas et al, 2019). Participants will be asked to indicate whether they performed any of 15 helping actions to support someone in the last 6 months.

Jorm, A.F., et al., Associations of training to assist a suicidal person with subsequent quality of support: results from a national survey of the Australian public. BMC psychiatry, 2018. 18(1): p. 1-7.
Nicholas, A., et al., Helping actions given and received in response to suicide risk: Findings from an Australian nationally representative telephone survey. SSM-population health, 2019. 9: p. 100483.
Timepoint [1] 392216 0
Baseline (pre-intervention) and 7 months after baseline (follow-up)
Secondary outcome [2] 392217 0
Changes in confidence to assist a person who is at risk of suicide. Participants will be asked to rate how confident they would feel supporting the person depicted in a vignette (Nicholas at al, 2020).

Nicholas, A., et al., Confidence and intentions to help a person at risk of suicide. Suicide Life-Threatening Behavior, 2020. 50(1): p. 138-150.
Timepoint [2] 392217 0
Baseline (pre-intervention) and 1 month (post-intervention) and 7 months after baseline (follow-up)
Secondary outcome [3] 392218 0
Changes in the endorsement of suicide prevention myths. Participants will be asked to indicate their agreement with items representing common suicide myths, the items will be based on previous research (Nicholas et al, 2020)

Nicholas, A., et al., Belief in suicide prevention myths and its effect on helping: a nationally representative survey of Australian adults. BMC psychiatry, 2020. 20(1): p. 1-12.
Timepoint [3] 392218 0
Baseline (pre-intervention) and 1 month (post-intervention) and 7 months after baseline (follow-up)
Secondary outcome [4] 392219 0
Changes in stigmatising attitudes about suicide, Participants will be asked to what extent they agree with statements designed to measure stigmatising attitudes. The stigma items will be based on the Depression Stigma Scale (Griffiths et al, 2004).

Griffiths, K.M., et al., Effect of web-based depression literacy and cognitive–behavioural therapy interventions on stigmatising attitudes to depression: Randomised controlled trial. The British Journal of Psychiatry, 2004. 185(4): p. 342-349.
Timepoint [4] 392219 0
Baseline (pre-intervention) and 1 month (post-intervention) and 7 months after baseline (follow-up)
Secondary outcome [5] 392220 0
Changes in the desire for social distance measured by the Social Distance Scale (Link et al, 1999).

Link, B.G., et al., Public conceptions of mental illness: labels, causes, dangerousness, and social distance. American journal of public health, 1999. 89(9): p. 1328-1333.
Timepoint [5] 392220 0
Baseline (pre-intervention) and 1 month (post-intervention) and 7 months after baseline (follow-up)
Secondary outcome [6] 392221 0
Changes in disclosure norms about suicide. Participants will be asked to what extent they agree with four statements adopted from other studies (LaMontagne et al, 2016; Martin, 2010).

LaMontagne, A.D., et al., An integrated workplace mental health intervention in a policing context: Protocol for a cluster randomised control trial. BMC psychiatry, 2016. 16(1): p. 1-13.
Martin, A., Individual and contextual correlates of managers' attitudes toward depressed employees. Human Resource Management, 2010. 49(4): p. 647-668.
Timepoint [6] 392221 0
Baseline (pre-intervention) and 1 month (post-intervention) and 7 months after baseline (follow-up)
Secondary outcome [7] 392222 0
Changes in helping actions received in response to suicide risk (based on Nicholas et al., 2019). Participants will be asked to indicate whether they received any of 15 helping actions in response to suicide risk in the last 6 months.

Nicholas, A., et al., Helping actions given and received in response to suicide risk: Findings from an Australian nationally representative telephone survey. SSM-population health, 2019. 9: p. 100483.
Timepoint [7] 392222 0
Baseline (pre-intervention) and 7 months after baseline (follow-up)
Secondary outcome [8] 392223 0
Changes in health related quality of life. Participants’ health related quality of life will be measured using the brief version of the assessment of quality of life instrument (AQoL-4D; Hawthorne, Richardson & Osborne, 1999).

Hawthorne, G., J. Richardson, and R. Osborne, The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Quality of life research, 1999. 8(3): p. 209-224.
Timepoint [8] 392223 0
Baseline (pre-intervention) and 7 months after baseline (follow-up)
Secondary outcome [9] 392415 0
Changes in mental health resource usage. Health care utilisation will be measured using adjusted items from the resource use questionnaire (RUQ; Chatterton, et al, 2018).

Chatterton, M.L., et al., Economic evaluation of a dietary intervention for adults with major depression (the “SMILES” trial). BMC Public Health, 2018. 18(1): p. 1-11.
Timepoint [9] 392415 0
Baseline (pre-intervention) and 7 months after baseline (follow-up)
Secondary outcome [10] 393441 0
Course quality and satisfaction. Five items will be used asking participants how new the information in the course was to them, how much of the information in the program they understood, how well the program was presented, how relevant the content was to them and how much they liked the different parts of the program (ie, handbook, PowerPoint slides, videos and activities). Additionally, two open-ended questions will ask participants what aspects of the course they find most helpful and if there is anything in the course that could be improved. This questionnaire was used in a previous MHFA study (Bond et al, 2021).

Bond, K.S., et al., Effects of the Mental Health First Aid for the suicidal person course on beliefs about suicide, stigmatising attitudes, confidence to help, and intended and actual helping actions: an evaluation. International Journal of Mental Health Systems, 2021. 15(1): p. 1-12.
Timepoint [10] 393441 0
One month after baseline (post-intervention)

Eligibility
Key inclusion criteria
Cluster: The local Men's Shed coordinator agrees to offer the MHFA Conversations about Suicide course to Shed members in their area and agrees to randomisation to the intervention or wait list group.
Participants: Male, member of a participating Men's Shed and agrees to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
No

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)
The allocation of clusters to the intervention or control group will be concealed. After a cluster is recruited by the trial manager, an off-site independent statistician will perform the stratified randomisation. They will inform the trial manager of the cluster allocation.
It will not be possible to blind participants to allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To minimise imbalance in cluster size and location across conditions, randomisation will occur via minimisation with the Stata package rct_minim. Cluster size and region will be the strata variables. Once a cluster is enrolled, the trial manager will send an independent statistician blinded details about the cluster (strata level) in order to generate the allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The course will be rolled out across 24 Men’s Shed clusters across Australia. We aim to include 24 participants per cluster (576 in total; 288 per arm). We will have 90% power, at a 2-sided 5% significance level, to detect a 0.3 standardised difference in mean intentions scores between intervention and control group at follow-up. This sample size calculation accounts for the clustering effect of Men’s Sheds (ICC=0.03), assumes a correlation of 0.50 between individual measurements over time, and allows for 20% loss to follow-up.

The effectiveness analyses will be undertaken on an intent-to-treat (ITT) basis. Mixed model repeated measures (MMRM) will be used including all available data, including that from participants who didn’t complete all surveys. A random effect of clusters will be estimated within each model, to account for clustering within Sheds. This method of analysis is well suited to the data as it takes into account the hierarchical structure of the data, i.e. the correlation of participants within clusters and measurement occasions within participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2021
Actual
14/07/2021
Date of last participant enrolment
Anticipated
31/05/2023
Actual
20/10/2023
Date of last data collection
Anticipated
30/04/2024
Actual
8/07/2024
Sample size
Target
576
Accrual to date
Final
340
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307962 0
Government body
Name [1] 307962 0
National Health and Medical Research Council
Country [1] 307962 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne School of Population and Global Health
207 Bouverie Street
Carlton VIC 3010
Country
Australia
Secondary sponsor category [1] 308678 0
None
Name [1] 308678 0
Address [1] 308678 0
Country [1] 308678 0
Other collaborator category [1] 281662 0
Other Collaborative groups
Name [1] 281662 0
Mental Health First Aid Australia
Address [1] 281662 0
Level 6/ 369 Royal Parade
Parkville VIC 3052
Country [1] 281662 0
Australia
Other collaborator category [2] 281663 0
Charities/Societies/Foundations
Name [2] 281663 0
Victorian Men Shed Association
Address [2] 281663 0
PO Box 211
Bulleen Vic 3105
Country [2] 281663 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307957 0
University of Melbourne Human Ethics Research Committee
Ethics committee address [1] 307957 0
Ethics committee country [1] 307957 0
Australia
Date submitted for ethics approval [1] 307957 0
17/02/2021
Approval date [1] 307957 0
07/04/2021
Ethics approval number [1] 307957 0
2021-20866-16138-3

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

Contacts
Principal investigator
Name 109038 0
Prof Nicola Reavley
Address 109038 0
Melbourne School of Population and Global Health
The University of Melbourne
Level 4/ 207 Bouverie Street
Carlton, Victoria 3010 Australia
Country 109038 0
Australia
Phone 109038 0
+61 390357628
Fax 109038 0
Email 109038 0
[email protected]
Contact person for public queries
Name 109039 0
Anna Ross
Address 109039 0
Melbourne School of Population and Global Health
The University of Melbourne
Level 4/ 207 Bouverie Street
Carlton, Victoria 3010 Australia
Country 109039 0
Australia
Phone 109039 0
+61 3 83447888
Fax 109039 0
Email 109039 0
[email protected]
Contact person for scientific queries
Name 109040 0
Nicola Reavley
Address 109040 0
Melbourne School of Population and Global Health
The University of Melbourne
Level 4/ 207 Bouverie Street
Carlton, Victoria 3010 Australia
Country 109040 0
Australia
Phone 109040 0
+61 390357628
Fax 109040 0
Email 109040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data after de-identification only.
When will data be available (start and end dates)?
Data will be available after publication of the main results, the end date is currently not determined.
Available to whom?
Data will be available upon request only and on a case-by-case basis.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator Prof. Nicola Reavley T: +61 3 9035 7628 E: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17823Study protocolOostermeijer S, Morgan A, Rossetto A, Kelly C, Pirkis J, Le LK, Mihalopoulos C, Reavley N. (2022). Mental Health First Aid suicide prevention training for men: Protocol for a cluster randomised controlled trial in Australian Men's Sheds. Mental Health & Prevention, 200250. doi: 10.1016/j.mhp.2022.200250https://www.sciencedirect.com/science/article/abs/pii/S2212657022000228 



Results publications and other study-related documents

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