Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000770864
Ethics application status
Approved
Date submitted
11/05/2021
Date registered
21/06/2021
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multimodal Approach to Preventing Suicide in Schools (MAPSS): A regionally-based trial of safeTALK and Reframe IT among secondary school students (safeTALK + screening component)
Scientific title
Multimodal Approach to Preventing Suicide in Schools (MAPSS): A regionally-based trial of safeTALK and Reframe IT among secondary school students (safeTALK + screening component)
Secondary ID [1] 304114 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
MAPSS
Linked study record
This study forms part of a larger study (the MAPSS project) which also involves delivery of an online CBT-based intervention (Reframe IT) to selected students. The online CBT intervention is being evaluated using a randomised controlled trial (see ACTRN12621000279820).

Health condition
Health condition(s) or problem(s) studied:
Depression 321794 0
Suicide 321795 0
Condition category
Condition code
Mental Health 319520 319520 0 0
Depression
Mental Health 319521 319521 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The safeTALK suicide alertness program was developed by LivingWorks Education. It is suitable for delivery to anyone over the age of 15. It comprises a single 3.5-hour workshop designed to help participants better understand suicide warning signs in themselves and others, gain knowledge about appropriate sources of help for suicidal feelings, apply basic ‘TALK’ steps (Tell, Ask, Listen, and KeepSafe), and feel better-able to connect a person at risk of suicide with appropriate help. safeTALK is delivered by trained staff, to groups of up to 30 participants at a time.

The safeTALK workshop primarily takes a didactic format, with the facilitator using multimedia tools including filmed vignettes to support information given to participants. It also incorporates a number of interactive activities and role plays. For this project, the original safeTALK vignettes used in Australia were re-scripted and re-filmed with young people to increase relevance of the training program for the study populations.

Adherence to the intervention will be assessed in two ways. First, participants will be asked how much of the training program they were present for in the safeTALK evaluation survey. Second, research staff present in the training sessions will monitor attendance and record any students who miss any portion of the training (including how much of the training was missed, and why).

SafeTALK will be evaluated using a pre-test/post-test design. As part of the questionnaires used to evaluate the training, students will also be screened for suicide risk using the Suicidal Ideation Attributes Scale (SIDAS) and a purpose-designed measure of current suicidal ideation. Students who report either past-month suicidal ideation or current suicidal ideation will be referred to the school wellbeing team.
Intervention code [1] 320447 0
Early detection / Screening
Intervention code [2] 320448 0
Prevention
Intervention code [3] 320449 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327389 0
Help-seeking from formal sources, assessed using the Resource Use Questionnaire
Timepoint [1] 327389 0
2-weeks post-baseline (immediate follow up) , 12-weeks post-baseline and 24-weeks post-baseline compared to baseline (0 weeks)
Primary outcome [2] 327390 0
Attitudes towards help-seeking from adults at schools, assessed using a 4-item measure derived from the US Sources of Strength trial and used in the Australian Sources of Strength trial.
Timepoint [2] 327390 0
2-weeks post-baseline (immediate follow up) , 12-weeks post-baseline and 24-weeks post-baseline compared to baseline (0 weeks)
Primary outcome [3] 327391 0
Willingness to Intervene against Suicide Questionnaire (WIS)
Timepoint [3] 327391 0
2-weeks post-baseline (immediate follow up) , 12-weeks post-baseline and 24-weeks post-baseline compared to baseline (0 weeks)
Secondary outcome [1] 395254 0
Stigma of Suicide Scale (SOSS)
Timepoint [1] 395254 0
2-weeks post-baseline (immediate follow up) , 12-weeks post-baseline and 24-weeks post-baseline compared to baseline (0 weeks)
Secondary outcome [2] 395255 0
Literacy of Suicide Scale (LOSS)
Timepoint [2] 395255 0
2-weeks post-baseline (immediate follow up) , 12-weeks post-baseline and 24-weeks post-baseline compared to baseline (0 weeks)
Secondary outcome [3] 395256 0
Acceptability of safeTALK, assessed using a purpose-designed questionnaire.
Timepoint [3] 395256 0
2-weeks post-baseline (immediate follow up)
Secondary outcome [4] 395257 0
Current suicidal thoughts, assessed using a purpose-designed questionnaire
Timepoint [4] 395257 0
2-weeks post-baseline (immediate follow up) compared to baseline (0 weeks)
Secondary outcome [5] 396641 0
PRIMARY OUTCOME: Help-seeking from informal sources (using a purpose-designed questionnaire)
Timepoint [5] 396641 0
2-weeks post-baseline (immediate follow up) , 12-weeks post-baseline and 24-weeks post-baseline compared to baseline (0 weeks)
Secondary outcome [6] 396642 0
PRIMARY OUTCOME: Attitudes towards overcoming secrecy barriers, assessed using a 4-item measure derived from the US Sources of Strength trial and used in the Australian Sources of Strength trial,
Timepoint [6] 396642 0
2-weeks post-baseline (immediate follow up) , 12-weeks post-baseline and 24-weeks post-baseline compared to baseline (0 weeks)

Eligibility
Key inclusion criteria
1. Current year 10 or 11 student at a secondary school in North West Melbourne; AND
2. Ability to provide written parental consent to participate.
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Intellectual disability;
2. Inability to converse in, or read English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For continuous outcomes, changes in each outcome measure over time will be assessed using a linear mixed effects model, parameterised such that coefficients refer to mean scores at each time point (by including terms for all 4 time points in the model but excluding the intercept term). Post-hoc analyses will explore change over time. Current suicidal ideation, the sole binary outcome, will be modelled using a population-averaged generalised estimating equation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/02/2020
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
17/07/2024
Actual
Sample size
Target
4200
Accrual to date
400
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308493 0
Government body
Name [1] 308493 0
National Health and Medical Research Council (NHMRC)
Country [1] 308493 0
Australia
Funding source category [2] 308494 0
Charities/Societies/Foundations
Name [2] 308494 0
Lifeline Australia
Country [2] 308494 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Youth Mental Health
35 Poplar Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 309344 0
None
Name [1] 309344 0
Address [1] 309344 0
Country [1] 309344 0
Other collaborator category [1] 281765 0
University
Name [1] 281765 0
Deakin University
Address [1] 281765 0
School of Health & Soc. Dev.
Deakin University
221 Burwood Highway
Burwood VIC 3125
Australia
Country [1] 281765 0
Australia
Other collaborator category [2] 281766 0
University
Name [2] 281766 0
University of Auckland
Address [2] 281766 0
Auckland Hospital - Bldg 599
Level 12, Room 12003
2 Park Road
Grafton
Auckland 1023
New Zealand
Country [2] 281766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308450 0
The University of Melbourne Psychology Health and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 308450 0
Office of Research Ethics & Integrity
Level 4, 161 Barry Street
The University of Melbourne
VIC 3010
Ethics committee country [1] 308450 0
Australia
Date submitted for ethics approval [1] 308450 0
15/11/2018
Approval date [1] 308450 0
22/01/2019
Ethics approval number [1] 308450 0
1852317
Ethics committee name [2] 308451 0
Research, Evaluation and Analytics Branch, Performance and Evaluation Division, Department of Education and Training
Ethics committee address [2] 308451 0
Research, Evaluation and Analytics Branch, Performance and Evaluation Division
Department of Education and Training
Level 3, 33 St Andrews Place
GPO Box 4367
Melbourne
VIC 3001
Ethics committee country [2] 308451 0
Australia
Date submitted for ethics approval [2] 308451 0
31/01/2019
Approval date [2] 308451 0
29/03/2019
Ethics approval number [2] 308451 0

Summary
Brief summary
This study involves the evaluation of safeTALK workshops delivered to secondary school students in North-West Melbourne. As part of the questionnaires used to evaluate the training, students will also be screened for risk and referred to the school wellbeing team.

It is hypothesised that completion of the safeTALK workshop will be associated with: increased intentions to intervene with a suicidal person; higher levels of suicide literacy; higher levels of perceived behavioural control regarding intervening with a suicidal person; reduced stigma towards suicide and suicidal behaviour, increased health-service use; increased help-seeking from informal sources; and, improved attitudes towards help-seeking. It is hypothesised that the screening will lead to the identification of students at risk of suicide-related behaviour who had not previously sought help. Finally, it hypothesised that the safeTALK program or screening will not be associated with iatrogenic effects.
Trial website
https://www.orygen.org.au/Research/Currently-recruiting/Multimodal-approach-to-preventing-suicide-in-schoo

Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110742 0
A/Prof Jo Robinson
Address 110742 0
Orygen
35 Poplar Road
Parkville
VIC 3052
Country 110742 0
Australia
Phone 110742 0
+61 412 999 140
Fax 110742 0
Email 110742 0
jo.robinson@orygen.org.au
Contact person for public queries
Name 110743 0
A/Prof Jo Robinson
Address 110743 0
Orygen
35 Poplar Road
Parkville
VIC 3052
Country 110743 0
Australia
Phone 110743 0
+61 412 999 140
Fax 110743 0
Email 110743 0
jo.robinson@orygen.org.au
Contact person for scientific queries
Name 110744 0
A/Prof Jo Robinson
Address 110744 0
Orygen
35 Poplar Road
Parkville
VIC 3052
Country 110744 0
Australia
Phone 110744 0
+61 412 999 140
Fax 110744 0
Email 110744 0
jo.robinson@orygen.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11548Study protocolByrne, S., Bailey, E., Lamblin, M., Pirkis, J., Mihalopoulos, C., Spittal, M., ... Robinson, J. Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: A regionally-based trial of an integrated response to suicide risk among secondary school students. Submitted to BMC Trials 09/12/2020.  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: a regionally based randomised trial of an integrated response to suicide risk among secondary school students.2022https://dx.doi.org/10.1186/s13063-022-06072-8
N.B. These documents automatically identified may not have been verified by the study sponsor.