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Trial registered on ANZCTR
Registration number
ACTRN12619000814178
Ethics application status
Approved
Date submitted
20/05/2019
Date registered
4/06/2019
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Suicide Prevention Public Service Announcements (PSAs): A Randomized Controlled Trial in Young Adults
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Scientific title
Suicide Prevention Public Service Announcements (PSAs): A Randomized Controlled Trial in Young Adults
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Secondary ID [1]
298236
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nil
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Universal Trial Number (UTN)
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Trial acronym
SuiPSA
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Linked study record
not applicable
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Health condition
Health condition(s) or problem(s) studied:
suicide
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Condition category
Condition code
Mental Health
311341
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0
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Suicide
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Public Health
311519
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
We will conduct a randomized
A total of 120 18-24 year olds will be recruited from the community and randomly allocated to view (a) suicide prevention Public Service Announcement or (b) a control PSA on an unrelated health
issue.
The suicide prevention PSA is a 30 second ad. The ad has been specifically designed for the project by young people. It features young people and it is about reaching to help a friend or peer who might be experiencing suicidal thought. It has never been viewed before.
Young people will not be able to proceed to completing the questionnaires if the video is not watched twice. This is monitored via the electronic data base .
At Time 1 (pre-viewing), participant will complete a series of outcome measures, At Time 2 (immediately post-viewing), participants will complete a questionnaire about the PSA itself and a measure of distress. At Time 3 (four weeks post-viewing), participants will re complete previously completed outcome measures.
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Intervention code [1]
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Prevention
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Comparator / control treatment
The control PSA is a 30 second ad about the health impacts of sugary drinks. It has been produced by the Cancer Council and has been shown on television.
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Control group
Active
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Outcomes
Primary outcome [1]
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Willingness to Intervene. The willingness to intervene will be assessed using the Willingness to intervene against suicide (WIS), a 22 item subscale that examines ones intention to
intervene and help one who might be experiencing suicidal thoughts and feelings. Items are rated on a 5-point Likert scale ranging from “very unlikely” to “Very Likely”.
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Assessment method [1]
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Timepoint [1]
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It will be measured at Time 1 at baseline, previewing the PSA and Time 3, 4 weeks post viewing the PSA.
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Secondary outcome [1]
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A change in psychological distress as measured by the Kessler-10 scale (K10). Short screening scales to monitor population prevalences and trends in non-specific psychological distress.
The K10 is a ten item scale that asks about symptoms of psychological distress in the past four weeks
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Assessment method [1]
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Timepoint [1]
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Baseline and at 4 weeks post viewing of the CSA
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Secondary outcome [2]
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The Adult Suicidal Ideation Questionnaire (ASIQ) is a 25 item scale that is designed to evaluate the presence and frequency of suicidal thoughts in an individual during the past month.
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Assessment method [2]
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Timepoint [2]
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Baseline and at 4 weeks post viewing of the CSA
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Eligibility
Key inclusion criteria
We will recruit 120 young people (aged 18-24) english speaking
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Minimum age
18
Years
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Maximum age
24
Years
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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
If participants score above 31 on the Adult Suicidal Ideation questionnaire they will be excluded from further participantion in the study
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data will be analysed on an intention-to-treat basis using standard techniques for longitudinal data analysis. We will analyse changes in each outcome measure by treatment group and time.
Changes in the willingness to intervene (as measured by the Willingness to Intervene (WIQ) Questionnaire) will be used as the primary outcome measure. A linear regression analyses using scores on the WIQ as the primary outcome of interest with the key predictor being the treatment group participants were randomised to. The analysis will also include a range of socio-demographic, clinical and treatment variables as covariates.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
11/06/2019
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Actual
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Date of last participant enrolment
Anticipated
30/11/2019
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Actual
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Date of last data collection
Anticipated
31/03/2020
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The American Foundation for Suicide Prevention
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Address [1]
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440 First Street, NW Suite 300. Washington, DC 20001
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Country [1]
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United States of America
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Primary sponsor type
University
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Name
University of Melbourne
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Address
The Centre for Mental Health, The Melbourne School of Population and Global Health,
The University of Melbourne,
207 Bouverie St
Victoria, 3010,
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Jane Pirkis
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Address [1]
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The Centre for Mental Health, The Melbourne School of Population and Global Health, The University of Melbourne, Victoria, 3010,
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Country [1]
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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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The University of Melbourne Medicine and Dentistry Human Ethics Sub-Committee,
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Ethics committee address [1]
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University of Melbourne
Parkville
Victoria
3010
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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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Approval date [1]
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03/04/2019
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Ethics approval number [1]
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Summary
Brief summary
Youth suicide is a major public health problem in Australia and worldwide. This study aims to build the evidence base for an effective public education campaign for young people. In particular we are testing to see if a 30 second ad can lead to reaching out and helping a peer at risk of suicide.120 young people will be recruited from the general population randomly allocated to view one of two PSA. The intervention PSA is about helping someone at risk of suicide and the control PSA is about the impact of sugary drinks. Participants will answer questions pre-viewing, post-viewing and four weeks later to permit an examination of several positive and negative outcomes.
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Trial website
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Trial related presentations / publications
nil
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Public notes
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Contacts
Principal investigator
Name
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Prof Jane Pirkis
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Address
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The University of Melbourne
Melbourne School of Population and Global Health
Centre for Mental Health
Level 4/ 207 Bouverie St
Carlton Victoria 3053
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Country
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Australia
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Phone
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+613 8344 0655
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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 Maria Ftanou
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Address
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The University of Melbourne
Melbourne School of Population and Global Health
Centre for Mental Health
Level 4/ 207 Bouverie St
Carlton Victoria 3053
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Country
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Australia
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Phone
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+613 8344 0655
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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 Maria Ftanou
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Address
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The University of Melbourne
Melbourne School of Population and Global Health
Centre for Mental Health
Level 4/ 207 Bouverie St
Carlton Victroria 3053
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Country
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Australia
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Phone
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+613 8344 0655
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Fax
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[email protected]
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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
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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
No additional documents have been identified.
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