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Trial registered on ANZCTR


Registration number
ACTRN12622000122752
Ethics application status
Approved
Date submitted
3/11/2021
Date registered
25/01/2022
Date last updated
25/01/2022
Date data sharing statement initially provided
25/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
MATES in Manufacturing: A workplace suicide prevention program cluster randomised controlled trial (RCT) for employees in the manufacturing industry
Scientific title
MATES in Manufacturing: A cluster RCT evaluation of the effect of a workplace suicide prevention program on suicide prevention literacy and help-seeking behaviours in employees in the manufacturing industry
Secondary ID [1] 305717 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide prevention literacy 324184 0
help-seeking behaviours 324185 0
suicidality 324186 0
psychological distress 324187 0
Condition category
Condition code
Mental Health 321664 321664 0 0
Suicide
Public Health 321665 321665 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MATES in Manufacturing is an adaptation of the MATES in Construction workplace suicide prevention program. A detailed program logic is available at https://mates.org.au/programlogic. In brief, MATES is an industry-based community development approach to mental health and suicide prevention. MATES does not provide clinical services but seeks to connect distressed workers to help. A one-hour universal General Awareness Training (GAT) is provided for all workers on a site. Volunteers are recruited during the GAT, and subsequently trained as 'Connectors'--the persons on site who can ‘connect’ workers in need to appropriate sources of help. Workers potentially in need of help can either approach a Connector him- or herself, or Connector might approach someone based on concerns expressed by a workmate. ‘Help’ in this context is for mental health or suicidality, and for financial, gambling, relationship, and other issues that could affect mental health. Volunteers are the key to the fabric of the MATES program, by design aiming for an average of 1/20 workers on-site trained as Connectors.

Implementation of GAT training on site is the starting point of the intervention. For those sites randomly assigned to intervention, the intervention will occur for 12 months during the study period, and then will continue beyond then at the discretion of the participating sites. Similarly, for sites randomly assigned to wait-list control, the intervention will begin 6 months from the date of initiation at intervention sites, and continue beyond the study period at the discretion of the participating sites.

The MATES program also includes Field Officers, who are employed directly by MATES to provide ongoing support to MATES sites through fortnightly site visits, establishing and maintaining relationships with workers on-site, and supporting Connectors in their role. In addition, MATES employs Case managers, who are qualified to assist troubled workers with a plan to effectively address their problems and concerns. This could include connecting workers with such services as their EAP, financial counselling, mental health services, drug and alcohol services, grief counselling, or family and relationship counselling MATES also has a national toll-free help line. The MATES in Manufacturing intervention will be delivered by the MATES in Construction organisation (https://mates.org.au/).

Further details on the three levels of training include:
• General Awareness Training (GAT) – a one-hour suicide literacy program delivered face-to-face on site. Includes information on suicide rates, possible contributing causes, and actions that can be taken to prevent suicide. Main take-away message to workers is—if you or a mate need help, talk to a Connector, and they’ll connect you or your mate to the help they need. Participants are given a white ‘MATES Inducted’ sticker to wear on their hard hat identifying them as ‘GAT-trained’. For a site to be designated ‘MATES compliant’, a minimum 80% training level must be maintained even with staff turnover.
• Connector Training – a four-hour gatekeeper program including Livingworks’ SafeTALK, delivered by LivingWorks-trained MATES staff (https://www.livingworks.com.au/). Connectors wear a green ‘MATES Connector’ sticker on their hard hats for easy identification.
• ASIST Worker Training – a 16-hour LivingWorks’ suicide intervention training program, delivered by LivingWorks-trained MATES staff. ASIST-workers wear a blue ‘MATES ASIST’ ’ sticker on their hard hats for easy identification.
Intervention code [1] 322105 0
Prevention
Intervention code [2] 322106 0
Behaviour
Comparator / control treatment
Wait-list control.
The MATES in Manufacturing program will be evaluated using a cluster RCT (randomised controlled trial) design, with waitlist controls. Those initially randomised to the intervention condition will start the program at month 0 (continuing through month 12), and waitlist control sites will start the program at month 6 (continuing through month 12). The trial will run for 12 months in total.
Control group
Active

Outcomes
Primary outcome [1] 329440 0
Help-seeking intentions will be measured using the General Help-seeking Behaviour Questionnaire (GHSQ). GSHQ questions will be modified to present twelve different sources of help seeking (including a MATES worker or Connector and an open-ended option for ‘other’), and participants will be asked to rank their help-seeking intentions “if you were feeling overwhelmed and unable to cope”; this phrasing was derived from a qualitative study in blue-collar male workers when asked about the best language to capture experiences of either personal/emotional problems or suicidal thoughts. Intentions will be ranked from extremely unlikely to extremely likely on a 7-point scale (Wilson, Deane, Ciarrochi, & Rickwood, 2005). A single summary measure across all the 12 options will be computed by summing the responses (reverse scoring the ‘no one’ option).

Wilson, C. J., Deane, F. P., Ciarrochi, J. V., & Rickwood, D. (2005). Measuring help seeking intentions: Properties of the general help seeking questionnaire. Canadian Journal of Counselling, 39(1), 15-28. https://ro.uow.edu.au/hbspapers/1527/
Timepoint [1] 329440 0
Baseline, pre-randomisation assessments will be conducted within one-two months before initiation of the intervention. For sites randomly assigned to treatment/intervention, intervention initiation will mark time 0, and outcomes will be assessed again at 6 and 12 months post-initiation of intervention. For sites randomly assigned to wait-list control, intervention initiation at treatment sites will mark time 0, and outcomes will be assessed again at 6 and 12 months.
Secondary outcome [1] 402633 0
Suicidality: Suicidal ideation and likelihood of future suicidal behaviour will be measured using 2-items from the 4-item version of the Suicidal Behaviour Questionnaire-Revised (SBQ-R) (Osman et al., 2001). The first item assesses the frequency of suicidal ideation in the past 6 months, and responses will be dichotomised (never/ever). The second item measures the likelihood of suicidal behaviour in the future (no chance/unlikely/likely).

Osman, A., Bagge, C. L., Gutierrez, P. M., Konick, L. C., Kopper, B. A., & Barrios, F. X. (2001). The Suicidal Behaviors Questionnaire-Revised (SBQ-R): Validation with clinical and nonclinical samples. Assessment, 8(4), 443-454. https://doi.org/10.1177/107319110100800409
Timepoint [1] 402633 0
Baseline, pre-randomisation assessments will be conducted within one-two months before initiation of the intervention. For sites randomly assigned to treatment/intervention, intervention initiation will mark time 0, and outcomes will be assessed again at 6 and 12 months post-initiation of intervention. For sites randomly assigned to wait-list control, intervention initiation at treatment sites will mark time 0, and outcomes will be assessed again at 6 and 12 months.
Secondary outcome [2] 402634 0
Psychological distress: Psychological distress will be measured using items from the Kessler-6 instrument (K6) (Kessler et al., 2003). Participants will be asked to indicate the response that best described their feelings in the past four weeks. Their responses will be ranked from 0 (none of the time) to 4 (all of the time). The six items will be combined to give a set of responses ranging from 0 to 24.

Kessler, R. C., Barker, P. R., Colpe, L. J., Epstein, J. F., Gfroerer, J. C., Hiripi, E., Howes, M. J., Normand, S. T., Manderscheid, R. W., & Walters, E. E. (2003). Screening for serious mental illness in the general population. Archives of General Psychiatry, 60(2), 184-189. https://doi.org/10.1001/archpsyc.60.2.184
Timepoint [2] 402634 0
Baseline, pre-randomisation assessments will be conducted within one-two months before initiation of the intervention. For sites randomly assigned to treatment/intervention, intervention initiation will mark time 0, and outcomes will be assessed again at 6 and 12 months post-initiation of intervention. For sites randomly assigned to wait-list control, intervention initiation at treatment sites will mark time 0, and outcomes will be assessed again at 6 and 12 months.

Eligibility
Key inclusion criteria
Employees in the manufacturing industry who are working at participating sites of the MATES in Manufacturing program, including permanent and casual employees.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals aged under 18 years.

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 concealed by having randomisation conducted off-site by a statistician who has had no contact with worksites or potential participants in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by a statistician who has had no contact with worksites or potential participants in the trial using a minimisation procedure as follows:
1. Sites will be allocated to intervention arms using minimisation implemented with the rct_minim procedure in Stata. Balance will be sought for a single factor – site size – with sites of less than 150 worker classified as ‘small’ and sites of 150 or more workers classed as ‘large.’
2. Where a single site has been recruited from an organisation, it will be assigned directly using the above method.
3. Where multiple sites from the same organisation are to be assigned to intervention arms, an additional step will be taken to assure balance within organisations.
a. A randomisation list will be created before any assignments are made using a block size of two.
b. This list will be used to allocate multiple sites in an organisation to direct assignment by minimisation or contingent assignment to the ‘other’ intervention by virtue of the assignment of other site in the block. A block size of two will ensure that for any pair of sites, one will be assigment to the active arm and the other to waitlist.
c. Where an even number of sites from the same organisation are to be assigned, multiple blocks will be used as necessary
d. Where an odd number of sites from the same organisation are to be assigned, the last site will be directly assigned using minimisation. The randomisation list will not be used for this site.
e. After contingent assignments are made, the balance table maintained by rct_minim will be updated manually so that the calculation of balance will reflect all assignments of sites to arm.
4. Sites will be assigned in order received and in order on recorded on lists received
5. If additional sites are recruited from the same organisation on different occasions, additional assignments will be independent of previous ones: contingency will not apply.
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
The primary analysis will be intention-to-treat: including all participants as randomised, regardless of treatment actually received or withdrawal from the study. Mixed-model Repeated Measures (MMRM) analyses will be used because of the ability of this approach to include participants with missing data. Cluster effects will be modelled using a random site effect. An unstructured residual variance-covariance matrix will accommodate within-participant dependency. The statistical significance of the primary outcome will be evaluated in a planned comparison of change from baseline to 6 months post-initiation of intervention in the active arm compared to change in the waitlist group. Tests of significance will use appropriate degrees of freedom adjustment where necessary (i.e., the Kenward-Roger method based on the observed information matrix). Where necessary, transformation of the outcome variable will be undertaken to ensure distributional assumptions of the model are met.

For binary outcomes (prevalence of suicidal ideation) and other non-continuous outcomes (severity of suicidal thoughts and behaviours), comparable generalized mixed models will be used with population average effects of intervention being compared.

As assignment to intervention is by site rather than individual, the possibility of imbalance in participant demographic or other factors can occur (Bolzern, Mitchell & Torgerson,2019).

We based our power and sample size calculations on the primary outcomes: intention to seek help from formal sources. From a current on-going MATES trial in construction workers (NMMRC Partnership Project entitled “MATES Mobile”, ACTRN12619000625178, Milner et al 2019), we have clustered data with which to estimate intra-class correlation (ICC) and the corresponding design effect. Our measure of intention to seek help for emotional problems from formal sources yielded an ICC estimate of 0.0112. To be conservative, we will use an ICC of 0.020. For our target effect size, or Minimally Important Difference (Cohen’s d, standardised difference in change between intervention and control groups in a two-arm trial), we have used 0.30; this effect size is very modest, but in the range of what has been achieved in previous workplace suicide prevention trials. Other inputs into power calculations included: Alpha = 0.05 and Beta = 0.80. Because we do not know in advance what our cluster sizes will be, a set of calculations has been done assuming a range of anticipated cluster sizes (30, 50 and 100). The above inputs yield the following sample and cluster size estimates for ICC = 0.02: 19 sites of cluster size = 30; 14 sites of cluster size = 50; and 10 sites of cluster size = 100.

In summary, at the lower cluster size of 30, we would need 19 sites, whereas if our cluster sizes average 100 or more, we will need roughly half the number of sites (10). Hence the target sample size in this protocol is estimated at 1000 is based on recruiting 10 sites of 100 workers each, acknowledging that the final sample size may vary based on worksite size.

In addition, we will conduct exploratory analyses to investigate whether intervention-associated changes differ by gender or by blue-collar versus white-collar/other workers.

References:
Bolzern, J. E., Mitchell, A., & Torgerson, D. J. (2019). Baseline testing in cluster randomised controlled trials: should this be done? BMC Medical Research Methodology, 19(1), 106. doi:10.1186/s12874-019-0750-8

Milner A, King TL, Scovelle AJ, Batterham PJ, Kelly B, LaMontagne AD, et al. A blended face-to-face and smartphone intervention for suicide prevention in the construction industry: Protocol for a randomized controlled trial with mates in construction. BMC Psychiatry 2019;19(1). https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-019-2142-3

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/11/2021
Date of last participant enrolment
Anticipated
1/02/2022
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
1000
Accrual to date
576
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 310075 0
Government body
Name [1] 310075 0
National Health & Medical Research Council (NHMRC)
Country [1] 310075 0
Australia
Primary sponsor type
Individual
Name
Professor Anthony D. LaMontagne
Address
Deakin University
Institute for Health Transformation
Level 3, Bldg BC
221 Burwood Highway
Burwood, VIC 3125
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 311130 0
None
Name [1] 311130 0
Address [1] 311130 0
Country [1] 311130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309766 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 309766 0
Ethics committee country [1] 309766 0
Australia
Date submitted for ethics approval [1] 309766 0
28/07/2021
Approval date [1] 309766 0
03/09/2021
Ethics approval number [1] 309766 0
2021-276

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

Contacts
Principal investigator
Name 115314 0
Prof Anthony D. LaMontagne
Address 115314 0
Deakin University
Institute for Health Transformation
Bldg BC, Level 3
221 Burwood Highway
Burwood, VIC 3125
AUSTRALIA
Country 115314 0
Australia
Phone 115314 0
+61392446802
Fax 115314 0
Email 115314 0
tony.lamontagne@deakin.edu.au
Contact person for public queries
Name 115315 0
Anthony D. LaMontagne
Address 115315 0
Deakin University
Institute for Health Transformation
Bldg BC, Level 3
221 Burwood Highway
Burwood, VIC 3125
AUSTRALIA
Country 115315 0
Australia
Phone 115315 0
+61392446802
Fax 115315 0
Email 115315 0
tony.lamontagne@deakin.edu.au
Contact person for scientific queries
Name 115316 0
Anthony D. LaMontagne
Address 115316 0
Deakin University
Institute for Health Transformation
Bldg BC, Level 3
221 Burwood Highway
Burwood, VIC 3125
AUSTRALIA
Country 115316 0
Australia
Phone 115316 0
+61392446802
Fax 115316 0
Email 115316 0
tony.lamontagne@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Permission from participating companies as well as individuals will be required.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14710Study protocol  tony.lamontagne@deakin.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of a workplace suicide prevention program in the Australian manufacturing industry: protocol for a cluster-randomised trial of MATES in manufacturing.2022https://dx.doi.org/10.1186/s12888-022-04464-3
N.B. These documents automatically identified may not have been verified by the study sponsor.