Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000876695
Ethics application status
Approved
Date submitted
1/08/2023
Date registered
15/08/2023
Date last updated
15/08/2023
Date data sharing statement initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the effectiveness of the Engaging Men in Crisis Support training program for Crisis Supporters at Lifeline Australia
Scientific title
A randomised controlled trial evaluating the effectiveness of the Engaging Men in Crisis Support training program for Crisis Supporters at Lifeline Australia
Secondary ID [1] 309543 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 329828 0
Condition category
Condition code
Mental Health 326729 326729 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Engaging Men in Crisis Support.

The intervention is an online professional development (PD) module for telephone Crisis Supporters (CSs) entitled Engaging Men in Crisis Support (EMICS). This is an e-learning consisting of three modules designed to supplement and extend upon Lifeline’s existing training frameworks, and as such has been developed with specific considerations of the helpline context in mind. The goal of the training program is to increase Crisis Supporters’ ability to engage with male help-seekers through the provision of targeted information about men’s gender socialization and skills to work with masculinities within the context of a Lifeline call. The PD consists of three modules: (1) Introduction: The Gender Agenda (2) The role of masculine norms in men’s distress and (3) How to best engage and support male help-seekers. Specifically, the modules focuse on three presentations that were identified as prevalent in male help-seekers and challenging to respond to by Lifeline Crisis Supporters: help-seekers who present as angry, help-seekers who may not communicate their emotions, and help-seekers looking for solutions or advice. The module is an interactive e-learning which uses character personas to illustrate interactions between the Crisis Supporter and male help-seekers and provide Crisis Supporters with opportunity to practice the demonstrated skills. The module also includes multiple self-reflection prompts for Crisis Supporters to reflect on their assumptions and beliefs about male help-seeking. Finally, the module includes information about how to access a tailored list of male-friendly referral resources for Crisis Supporters to utilise with male help-seekers.

Materials: EMICS is delivered as an interactive self-paced e-learning. Learning materials include informational text and images, self-reflection activities and self-check quizzes, and character vignettes and example phone interactions between men and crisis supporters developed to build skills in responding to the presentations discussed above. Key skills taught have been converted to resource sheets that are downloadable for Crisis Supporters to keep after the training.
Procedures and mode of delivery: Once pre-training surveys are completed, Crisis Supporters will be provided access to the EMICS training via Lifeline's e-learning platform delivered through Moodle. They will access all training materials though this platform and will work through the training individually at their own pace. Crisis Supporters will be able to contact the Lifeline Research Manager, who co-wrote the training, should they have any questions about training content or completing the training.
Dose: Approximately 3 hours, completed at participants' own pace.
Duration: Participants will have 4 weeks to complete the training module prior to the post-training survey. They will have ongoing access to the module for the duration of the trial should they wish to revisit the content. So Crisis Supporters will be exposed to the training content a minimum of 1 time but with no upper limit.
Location: Training delivery location is online.
Adherence to intervention: Crisis Supporters will be sent reminder emails during the training period to maximize completion rates. Completion status of the training with be confirmed via the e-learning system prior to phase 2 of the trial.

Intervention development
The development of EMICS involved extensive collaboration between researchers, Lifeline practice staff, lived experience consumers and consultants, and learning and user design experts. Training development was informed by the research team’s prior work in developing training for mental health practitioners in engaging male clients (see Men in Mind, Seidler et al., 2022; ACTRN12621001669886) and qualitative research with male consumers of helplines, Lifeline Crisis Supporters and Lifeline staff (HREC ID 22987). The Lifeline Lived Experience Advisory Group (LLEAG) provided input into the development of the module at various points across the life of the project. Consultation was completed to gain lived experience insight into identification and refinement of content areas for the module, development of the character personas, review of the training content, and user experience testing. Two Crisis Supporters and two supervisors who participated in the qualitative research were also engaged in user experience testing of the final module.

Study timeline
This study will take place over two main phases.

Phase 1 will consist of gathering data from and providing training to CSs. After consenting CSs complete the eligibility (T0) survey, eligible CSs will then complete the T1 survey, after which they will be randomised to the intervention group (group A) or the control group (group B). Group A will be provided access to the Engaging Men in Crisis Support (EMICS) training: a self-paced e-learning module developed to provide CSs with additional skills in engaging with male callers at Lifeline, expected to take approximately 3-hours. Group B will be provided access to an existing e-learning training, Child Safety and Crisis Support: a self-paced e-learning focused on identifying and responding to child safety concerns during interactions with callers, expected to take approximately 2 hours. Both groups will have four weeks to complete their designated training. The T2 survey will then be sent to participants in both groups at the end of this 4-week period. Participants in group B will also be provided access to the EMICS after the trial is complete.

Phase 2 will gather data from callers receiving support from participating CSs. CSs who do not complete their assigned training intervention will not be included in Phase 2. Callers waiting in Lifeline’s 13 11 14 queue will be notified that they may be provided with the opportunity to complete a brief survey after their interaction with a CS has concluded. Callers will be randomly allocated to CSs in either group A or group B and will complete their call based on CS availability (i.e., minimising caller wait times will take precedence over even allocation to conditions). Callers who wait more than five minutes to speak to a trial CS will be transferred back to Lifeline’s 13 11 14 queue with priority. At the end of their call, the CS will invite eligible callers to participate in a survey delivered through the Interactive Voice Response (IVR) system to provide their anonymous data for the purpose of service evaluation. Callers will be able to decline participation verbally, or by opting-out of the survey by hanging up at any point.
Callers will enter Lifeline’s 13 11 14 queue as per normal. Prior to their call while waiting to be connected to an available CS, they will be informed via a recorded message that they may have the option of completing a short survey after their interaction with a CS has concluded. Callers will provide opt-in consent by remaining on the line at the end of their interaction and completing the evaluation items. Callers will then be presented with the service evaluation questions and will answer using the number keys on their phone or cellular device. Callers can withdraw consent at any time by hanging up the phone. It is conservatively estimated that additional required time for callers in the trial to complete the post-call survey is 2-5 minutes.

Intervention code [1] 325969 0
Behaviour
Comparator / control treatment
Crisis Supporters randomised to the control condition will complete Child Safety and Crisis Support: a self-paced e-learning focused on identifying and responding to child safety concerns during interactions with callers, expected to take approximately 2 hours
Control group
Active

Outcomes
Primary outcome [1] 334594 0
Post-call male caller ratings of distress. This item was chosen because it was the most highly rated outcome in a recent three-panel Delphi study on key outcomes in crisis support (pre-print available at https://doi.org/10.31234/osf.io/x3guz). Items are rated on a 5-point Likert scale of (1) strongly disagree to (5) strongly agree. Callers can also select (0) for non-applicable. Callers can enter their response using the number key on their telephone/cellular device.
Timepoint [1] 334594 0
Completed by callers immediately after their call with a Lifeline Crisis Supporter. This outcome will be collected from callers who interact with participating Crisis Supporters from Phase 2 start (i.e., once CSs have completed their assigned training module) until target sample number of callers reached (estimated to be 12-18 months after Phase 2 start)
Secondary outcome [1] 421399 0
Post-call male caller ratings of feeling heard after speaking with Lifeline. This item was chosen because it was the second-most highly rated outcome in a recent three-panel Delphi study on key outcomes in crisis support (pre-print available at https://doi.org/10.31234/osf.io/x3guz). Items are rated on a 5-point Likert scale of (1) strongly disagree to (5) strongly agree. Callers can also select (0) for non-applicable. Callers can enter their response using the number key on their telephone/cellular device.
Timepoint [1] 421399 0
Completed by callers immediately after their call with a Lifeline Crisis Supporter. This outcome will be collected from callers who interact with participating Crisis Supporters from Phase 2 start until target sample number of callers reached (estimated to be 12-18 months after Phase 2 start)
Secondary outcome [2] 421400 0
Post-call male caller ratings of suicide risk after speaking with Lifeline. This item was chosen because it was the third-most highly rated outcome in a recent three-panel Delphi study on key outcomes in crisis support (pre-print available at https://doi.org/10.31234/osf.io/x3guz). Items are rated on a 5-point Likert scale of (1) strongly disagree to (5) strongly agree. Callers can also select (0) for non-applicable. Callers can enter their response using the number key on their telephone/cellular device.
Timepoint [2] 421400 0
Completed by callers immediately after their call with a Lifeline Crisis Supporter. This outcome will be collected from callers who interact with participating Crisis Supporters from Phase 2 start until target sample number of callers reached (estimated to be 12-18 months after Phase 2 start)
Secondary outcome [3] 421401 0
Adapted Clinical Skills subscale of the Development of Psychotherapists Common Core Questionnaire (DPCCQ).
Timepoint [3] 421401 0
Completed by Crisis Supporters at T1 (start of Phase 1 - prior to group assignment) and T2 (4 weeks after assignment to conditions - after Crisis Supporters have completed their assigned training module).
Secondary outcome [4] 421402 0
Adapted Professional Self-Doubt subscale of the Development of Psychotherapists Common Core Questionnaire (DPCCQ).
Timepoint [4] 421402 0
Completed by Crisis Supporters at T1 (start of Phase 1 ) and T2 (End of Phase 1 - 4 weeks after assignment to conditions).
Secondary outcome [5] 421403 0
Adapted Session Management subscale of the Counsellor Activities Self Efficacy Scale (CASES).
Timepoint [5] 421403 0
Completed by Crisis Supporters at T1 (start of Phase 1 ) and T2 (End of Phase 1 - 4 weeks after assignment to conditions).
Secondary outcome [6] 421404 0
Confidence to respond to male callers using bespoke items adapted from Seidler and colleagues’ (2022).
Timepoint [6] 421404 0
Completed by Crisis Supporters at T1 (start of Phase 1 ) and T2 (End of Phase 1 - 4 weeks after assignment to conditions).
Secondary outcome [7] 421405 0
Exploratory: Open-ended survey questions regarding training experiences, reflections on how learnings are implemented into practice, areas for future training refinement.
Timepoint [7] 421405 0
Completed by Crisis Supporters in the intervention condition only at T2 (End of Phase 1 - 4 weeks after assignment to conditions).

Eligibility
Key inclusion criteria
Lifeline centres:
Lifeline’s 4 largest members, comprising 22 individual centres, will be invited to advertise the study to their CSs. Centres must commit to continuing to provide their CSs with their standard support approaches, including reflexive practice sessions and debriefing with their in-shift supervisor, in the unlikely event that there is distress due to participating in the research study.

Callers:
• Provide opt-in consent to the post-call survey by staying on the line after interaction with CS ends.
While the focus of the trial is on male caller outcomes, data from callers of all genders will be collected. This data will be used to compare the effectiveness of the EMICS intervention between gender groups.

Crisis Supporters:
• Completes paid shifts at a participating Lifeline centre, and normally completes a minimum of 1 four hour shift per fortnight.
• Is able to partake in online study elements including completion of training module and study assessments.
• Phase 2 only: Has completed assigned Phase 1 training module.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Callers:
• The CS has followed the Decision Support Tool protocols to the SUPPORT stage and deems that the help seeker's (HS) safety is still at immediate risk/experiencing a high level of distress at the end of the call.
• Deemed as ‘unwelcome’ calls by CSs (i.e., inappropriate or abusive). These calls will be ended prior to being transferred to the post-call survey in line with Lifeline policy.

Crisis Supporters:
• Previous completion of Men in Mind training program (Seidler, Wilson, Owen, et al., 2021) or the Male-Friendly Counselling: Enhancing Therapy Work with Men professional development training (Flyer available at https://psychology.org.au/aps/media/events/attachments/21160/male-friendly-counselling-2020_1.pdf).
• Previous participation in qualitative interview or focus group regarding experiences of supporting male callers at Lifeline conducted by The University of Melbourne (conducted in May-April 2022).
• Prior exposure to or completion of the Engaging Men in Crisis Support training program.

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)
Callers:
Allocation of callers will occur automatically through Lifeline's telephony system based on Crisis Supporter availability to ensure all calls are answered as promptly as possible. Callers’ phone numbers will be de-identified through allocation of a unique ID in order to filter by repeated callers. The statistician will access caller data in this anonymised format through Lifeline’s specialised data platform.

Crisis Supporters:
The statistician will provide the allocation sequence to Logicly, the data management sub-contractor, who will be responsible for allocating Crisis Supporters into the control and intervention group, and providing them with email links to complete the evaluation surveys. Logicly will provide the final data to the researchers in de-identified, blinded format.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Callers
Callers will enter Lifeline’s 13 11 14 call queue as per normal. Callers will be randomly allocated to CSs participating in the trial in either the control or intervention group based on CS availability to ensure every call is answered as promptly as possible. This is anticipated to result in a randomisation of callers into the control or the intervention group with approximately a 1:1 ratio.

Crisis Supporters:
CSs will be randomised in a 1:1 ratio to the intervention or control group using an allocation sequence stratified by participant gender. The statistician will generate the randomisation sequence before recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This study is a two-stage, double-randomized RCT. In Phase 1, CSs will be randomized to the intervention group (group A: Engaging Men in Crisis Support module) or control group (group B: Child Safety and Crisis Support module) with a 1:1 allocation with stratification by CS gender (male; female/non-binary). Phase 1 consists of training CSs with their allocated module and obtaining evaluative data via online surveys. Data collection in phase 1 will occur at three time points for CSs: informed consent and eligibility screening, pre-training survey, and post-training survey.
In phase 2, callers will be randomised to receive support from CSs either in the intervention or control group with a 1:1 allocation randomised based on CS availability. For callers, data collection will occur at one time point via a post-call survey (immediately after their Lifeline call) with no follow up.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical methods used to determine the required sample size for this trial are outlined in section 4.2 of the attached protocol.
The statistical methods that will be used to analyse the results are outlined in section 9 of the attached protocol.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3640
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 313734 0
Government body
Name [1] 313734 0
NHMRC Medical Research Future Fund (MRFF)
Country [1] 313734 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 315549 0
None
Name [1] 315549 0
Address [1] 315549 0
Country [1] 315549 0
Other collaborator category [1] 282671 0
Other
Name [1] 282671 0
Lifeline Australia
Address [1] 282671 0
L 12, 70 Phillip Street
Sydney NSW, 2000
Australia
Country [1] 282671 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312906 0
Office of Research Ethics and Integrity (OREI), University of Melbourne
Ethics committee address [1] 312906 0
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010, Australia
Ethics committee country [1] 312906 0
Australia
Date submitted for ethics approval [1] 312906 0
12/04/2023
Approval date [1] 312906 0
10/05/2023
Ethics approval number [1] 312906 0
2023-26011-40150-3

Summary
Brief summary
This project represents a partnership between the Lifeline Research Office, Lifeline Australia and the Centre for Mental Health, The University of Melbourne.

Men represent approximately 40% of callers to Lifeline, however they account for 75% of suicide deaths in Australia. Past research has highlighted that many men struggle to engage with mental health services such as helplines due to the influence of traditional masculine norms, such as the expectation that men be self-reliant and in control of their emotions. These norms also influence the way men experience mental distress, making them more likely to experience anger, irritability, substance misuse, and risk-taking. In interviews with Lifeline Crisis Supporters, we found that Crisis Supporters felt they would benefit from further training around understanding male presentations of distress, and how to engage with callers to Lifeline.

The objective of the trial is to determine the impact of the Engaging Men in Crisis Support professional development (PD) program on male callers’ outcomes at Lifeline measured via a caller outcome survey. Lifeline have partnered with The University of Melbourne’s Centre for Mental health to develop a world-first training program Crisis Supporters, called Engaging Men in Crisis Support. The development of this training was guided by lived/living experience interviews with Crisis Supporters and male consumers of helplines, subject matter experts, and best-practice guidelines. This training aims to inform Crisis Supporters regarding common presentations among male-identifying help-seekers and provide the skills to effectively engage and support these help-seekers

It is hypothesised that male callers who receive care from a Crisis Supporter (CS) who has completed the Engaging Men in Crisis Support training will report lower ratings of feeling distressed than male callers receiving standard care following a call to Lifeline.
Trial website
https://lifeinmind.org.au/buoy-project/lifeline-australia
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126290 0
Prof Jane Pirkis
Address 126290 0
Melbourne School of Population and Global Health
The University of Melbourne
Grattan Street, Parkville,
Victoria, 3010, Australia
Country 126290 0
Australia
Phone 126290 0
+61 3 8344 0647
Fax 126290 0
Email 126290 0
j.pirkis@unimelb.edu.au
Contact person for public queries
Name 126291 0
Prof Jane Pirkis
Address 126291 0
Melbourne School of Population and Global Health
The University of Melbourne
Grattan Street, Parkville,
Victoria, 3010, Australia
Country 126291 0
Australia
Phone 126291 0
+61 3 8344 0647
Fax 126291 0
Email 126291 0
j.pirkis@unimelb.edu.au
Contact person for scientific queries
Name 126292 0
Prof Jane Pirkis
Address 126292 0
Melbourne School of Population and Global Health
The University of Melbourne
Grattan Street, Parkville,
Victoria, 3010, Australia
Country 126292 0
Australia
Phone 126292 0
+61 3 8344 0647
Fax 126292 0
Email 126292 0
j.pirkis@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant outcome data. Statistical code used for analyses will be included in any relevant publications resulting from the trial.
When will data be available (start and end dates)?
Following publication of primary results; no end date determined.
Available to whom?
Researchers who provide a methodologically sound proposal and who have ethics approval from a research institution. This will be determined on a case-by-case basis at the discretion of Lifeline and the Principal Investigator.
Available for what types of analyses?
All.
How or where can data be obtained?
The data will be stored on servers at the University of Melbourne. Participant level-data will only be shared under conditions allowed by the Services Agreement between the University of Melbourne and Lifeline and by the Data Access Agreement between the research team members and Lifeline. Interested parties can email Jane Pirkis (j.pirkis@unimelb.edu.au) to organise a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19121Ethical approval    Attached 385808-(Uploaded-01-08-2023-11-35-19)-Study-related document.pdf
19122Informed consent form    385808-(Uploaded-01-08-2023-11-35-52)-Study-related document.docx
19845Study protocol    385808-(Uploaded-01-08-2023-11-36-05)-Study-related document.docx



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