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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.
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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.
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Secondary ID [1]
297962
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Suicide
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health literacy
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Condition category
Condition code
Mental Health
310927
310927
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0
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Suicide
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314183
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Prevention
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Intervention code [2]
314184
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.
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Secondary outcome [1]
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Outcome and Measure
1. Suicidal ideation and behaviours: revised version of the Suicidal Behavior Questionnaire-Revised
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Assessment method [1]
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Timepoint [1]
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Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.
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Secondary outcome [2]
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Outcome and Measure
1. Psychological distress : Kessler-6 instrument
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Assessment method [2]
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Timepoint [2]
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Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.
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Secondary outcome [3]
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Outcome and Measure
Psychosocial risks in the workplace: Psychosocial Safety Climate (PSC-12)
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Assessment method [3]
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Timepoint [3]
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Baseline assessment (a longer survey) prior to the 8 week intervention, followed by smaller assessments at 3, 6 and 12 months.
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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.
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
None
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2019
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Actual
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Date of last participant enrolment
Anticipated
31/01/2020
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
844
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC Partner Project APP1134499
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Address [1]
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414 La Trobe St, Melbourne VIC 3000
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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MATES in Construction
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Address [2]
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1/35 Astor Terrace, Spring Hill QLD 4000
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Country [2]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Cbus
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Address
Level 26, 2 Lonsdale Street, Melbourne VIC 3000
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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CPB Contractors
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Address [1]
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Level 18, 177 Pacific Highway North Sydney NSW 2060 Australia
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Country [1]
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Australia
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Secondary sponsor category [2]
302387
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Commercial sector/Industry
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Name [2]
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Lendlease
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Address [2]
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Level 14, Tower Three International Tower Sydney Exchange Place 3000 Barangaroo Avenue Barangaroo NSW 2000
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Country [2]
302387
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Australia
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Secondary sponsor category [3]
302390
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Commercial sector/Industry
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Name [3]
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Multiplex Australasia - Brookfield Company
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Address [3]
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Level 22, 135 King Street Sydney NSW 2000
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Country [3]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Medicine and Dentistry Human Ethics Sub-Committee - University of Melbourne
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Ethics committee address [1]
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Level 4, 207 Bouvrie Street Carlton Vic 3000
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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07/06/2018
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Approval date [1]
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25/07/2018
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Ethics approval number [1]
303143
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1852200
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Summary
Brief summary
Construction workers are at elevated risk of suicide. MATES in Construction (MATES) is one of the few suicide prevention programs that explicitly address this problem. The MATES program includes an integrated system of services that supports prevention, early intervention and recovery (i.e., primary, secondary and tertiary prevention) for mental health problems among construction workers. In this protocol, we describe a proposed evaluation of MATESmobile, an electronic platform which will be accessed by workers who have undergone MATES training.
In this protocol, we describe a Randomised Controlled Trial (RCT) which seeks to assess whether MATESmobile results in improved literacy regarding suicide prevention, and improved help-seeking and help-offering attitudes among those who have attended MATES training. Secondary outcomes include changes in suicide ideation, suicide attempt and psychological distress. Workers will be recruited prior to MATES face-to-face training. In total, 295 workers will be randomly assigned to the intervention condition (MATESmobile + face-to-face training) and 295 will be randomly allocated to the control (face-to-face training). The intervention will run for 8 weeks. Assessments will be run immediately post intervention, and at 3, 6, and 12 months.
MATESmobile offers the potential to reinforce and enhance the effects of face-to-face training, resulting in greater skills and knowledge in suicide prevention, as well as a reduction in suicidality and distress.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Allison Milner
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Address
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Centre for Health Equity, School of Population and Global Health, University of Melbourne
207 Bouvrie Street, Carlton, VIC 3010, Australia
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Country
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Australia
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Phone
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+613 92517215
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Humaira Maheen
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Address
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Centre for Health Equity, School of Population and Global Health, University of Melbourne
207 Bouvrie Street, Carlton, VIC 3010, Australia
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Country
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Australia
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Phone
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+61390353406
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Tania King
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Address
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Centre for Health Equity, School of Population and Global Health, University of Melbourne
207 Bouvrie Street, Carlton, VIC 3010, Australia
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Country
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Australia
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Phone
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+61383448730
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The data is owned jointly with another organisation.
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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
Source
Title
Year of Publication
DOI
Embase
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.
2019
https://dx.doi.org/10.1186/s12888-019-2142-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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