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Trial registered on ANZCTR


Registration number
ACTRN12619000625178
Ethics application status
Approved
Date submitted
15/04/2019
Date registered
26/04/2019
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A blended face-to-face and smartphone intervention for suicide prevention in the construction industry (MATESMobile): protocol for a randomized controlled trial with MATES in Construction.
Scientific title
A blended face-to-face and smartphone intervention for suicide prevention in the construction industry (MATESMobile): protocol for a randomized controlled trial with MATES in Construction.
Secondary ID [1] 297962 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 312369 0
health literacy 312370 0
Condition category
Condition code
Mental Health 310927 310927 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Introduction
Mates in Construction (MATES) is an industry-based multi-component prevention and early intervention program, consistent with the Australian National Suicide Prevention Strategy. The core component of the MATES training is the General Awareness Training (GAT), a 45-minute face-to-face awareness session on ‘suicidality and associated help seeking behaviour’ provided to all construction workers on site. The other components of MATES programs include training to the gatekeepers, field officers, and case managers but they are outside the scope of this study.

MATESmobile program will send information about suicide prevention literacy, help offering skills and help seeking behaviour through text based messages and online videos.

Intervention

After completion of standard GAT face-to-face training, we will allocate participants to intervention and control groups. Those allocated to the MATESmobile program (intervention group) will be contacted via smartphone application every two weeks for 8 weeks with information about how to access the program. We will conduct baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months. The controls will receive all components of GAT training but would not be allocated to the program content via MATESmobile.

Participants in both conditions will complete online surveys (following the written baseline survey), which will be delivered to their smart phone via “alerts”. The “alerts” will re-direct respondents to an online survey. The surveys will be confidential, but not anonymous, as we will need to link baseline to follow up surveys, which will be done using mobile telephone numbers. Identifying information will also enable personalized re-contacts for non-response (which may be conducted via email and/or text messaging). The app will be available on Android, iOS and Windows mobile systems.

The MATESmobile app will send reminders to complete the online survey for participants in both groups. If individuals do not complete a survey within three days of receiving it, they will receive a text message reminder every three days to encourage them to take the survey. A total of 3 text messages will be sent. If the participant has still not responded within three days after the final text message, the Program Manager will phone them once and contact them directly.
Intervention code [1] 314183 0
Prevention
Intervention code [2] 314184 0
Behaviour
Comparator / control treatment
Control condition
Those in the control arm will complete a baseline survey, GAT training, and additional surveys at 3, 6 and 12 months following baseline.
Control group
Active

Outcomes
Primary outcome [1] 319743 0
Composite primary outcomes and Measures
1. Socio-demographic data: Survey questions include age, sex and educational levels as collected by the Australian Bureau of Statistics
2. Suicide prevention literacy: GAT suicide awareness questionnaire, which asks about suicide knowledge, attitudes, and behaviours
3. Help-seeking and help-offering behaviour: General Help-Seeking Questionnaire and the GAT help-seeking and help-offering items.
Timepoint [1] 319743 0
Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.
Secondary outcome [1] 369382 0

Outcome and Measure
1. Suicidal ideation and behaviours: revised version of the Suicidal Behavior Questionnaire-Revised
Timepoint [1] 369382 0
Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.

Secondary outcome [2] 369577 0
Outcome and Measure
1. Psychological distress : Kessler-6 instrument

Timepoint [2] 369577 0
Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.
Secondary outcome [3] 369692 0
Outcome and Measure
Psychosocial risks in the workplace: Psychosocial Safety Climate (PSC-12)
Timepoint [3] 369692 0
Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.

Eligibility
Key inclusion criteria
Participants need to be recruited from a site where MATES is operational. Workers attending GAT will be considered eligible for the study.
Minimum age
15 Years
Maximum age
No limit
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 concealment will be achieved by generating a set of computerised random numbers which will be assigned to participants. We will randomise in blocks of 50 participants. Hence, once 50 persons have returned their consent form, they will be allocated a random number. Once a block of 50 participants is obtained, the random numbers will be sent to a statistician external to the trial for allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The project manager will enrol participants.Participation numbers will be provided to a statistician external to the trial who will randomise participants into either the MATESmobile condition or control condition (MATES face-to-face only). The statistician will generate the allocation sequence for randomisation using a computer-based randomisation algorithm. The statistician will not reveal which of the participants are allocated to the intervention or control conditions to those involved in the design and evaluation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
31/01/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
844
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 302481 0
Government body
Name [1] 302481 0
NHMRC Partner Project APP1134499
Country [1] 302481 0
Australia
Funding source category [2] 302487 0
Charities/Societies/Foundations
Name [2] 302487 0
MATES in Construction
Country [2] 302487 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cbus
Address
Level 26, 2 Lonsdale Street, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 302386 0
Commercial sector/Industry
Name [1] 302386 0
CPB Contractors
Address [1] 302386 0
Level 18, 177 Pacific Highway North Sydney NSW 2060 Australia
Country [1] 302386 0
Australia
Secondary sponsor category [2] 302387 0
Commercial sector/Industry
Name [2] 302387 0
Lendlease
Address [2] 302387 0
Level 14, Tower Three International Tower Sydney Exchange Place 3000 Barangaroo Avenue Barangaroo NSW 2000
Country [2] 302387 0
Australia
Secondary sponsor category [3] 302390 0
Commercial sector/Industry
Name [3] 302390 0
Multiplex Australasia - Brookfield Company
Address [3] 302390 0
Level 22, 135 King Street Sydney NSW 2000
Country [3] 302390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303143 0
Medicine and Dentistry Human Ethics Sub-Committee - University of Melbourne
Ethics committee address [1] 303143 0
Ethics committee country [1] 303143 0
Australia
Date submitted for ethics approval [1] 303143 0
07/06/2018
Approval date [1] 303143 0
25/07/2018
Ethics approval number [1] 303143 0
1852200

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

Contacts
Principal investigator
Name 92622 0
A/Prof Allison Milner
Address 92622 0
Centre for Health Equity, School of Population and Global Health, University of Melbourne
207 Bouvrie Street, Carlton, VIC 3010, Australia
Country 92622 0
Australia
Phone 92622 0
+613 92517215
Fax 92622 0
Email 92622 0
allison.milner@unimelb.edu.au
Contact person for public queries
Name 92623 0
Humaira Maheen
Address 92623 0
Centre for Health Equity, School of Population and Global Health, University of Melbourne
207 Bouvrie Street, Carlton, VIC 3010, Australia
Country 92623 0
Australia
Phone 92623 0
+61390353406
Fax 92623 0
Email 92623 0
humaira.maheen@unimelb.edu.au
Contact person for scientific queries
Name 92624 0
Tania King
Address 92624 0
Centre for Health Equity, School of Population and Global Health, University of Melbourne
207 Bouvrie Street, Carlton, VIC 3010, Australia
Country 92624 0
Australia
Phone 92624 0
+61383448730
Fax 92624 0
Email 92624 0
tania.king@unimelb.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
The data is owned jointly with another organisation.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA blended face-to-face and smartphone intervention for suicide prevention in the construction industry: Protocol for a randomized controlled trial with MATES in Construction.2019https://dx.doi.org/10.1186/s12888-019-2142-3
N.B. These documents automatically identified may not have been verified by the study sponsor.