Trial Review

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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
Scientific title
Suicide Prevention Public Service Announcements (PSAs): A Randomized Controlled Trial in Young Adults
Secondary ID [1] 298236 0
nil
Universal Trial Number (UTN)
Trial acronym
SuiPSA
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
suicide 312837 0
Condition category
Condition code
Mental Health 311341 311341 0 0
Suicide
Public Health 311519 311519 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314484 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 320067 0
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”.
Timepoint [1] 320067 0
It will be measured at Time 1 at baseline, previewing the PSA and Time 3, 4 weeks post viewing the PSA.
Secondary outcome [1] 370444 0
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



Timepoint [1] 370444 0
Baseline and at 4 weeks post viewing of the CSA
Secondary outcome [2] 370445 0
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.
Timepoint [2] 370445 0

Baseline and at 4 weeks post viewing of the CSA

Eligibility
Key inclusion criteria
We will recruit 120 young people (aged 18-24) english speaking
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If participants score above 31 on the Adult Suicidal Ideation questionnaire they will be excluded from further participantion in the study

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)
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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2019
Actual
Date of last participant enrolment
Anticipated
30/11/2019
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302776 0
Charities/Societies/Foundations
Name [1] 302776 0
The American Foundation for Suicide Prevention
Country [1] 302776 0
United States of America
Primary sponsor type
University
Name
University of Melbourne
Address
The Centre for Mental Health, The Melbourne School of Population and Global Health,
The University of Melbourne,
207 Bouverie St
Victoria, 3010,
Country
Australia
Secondary sponsor category [1] 302727 0
Individual
Name [1] 302727 0
Jane Pirkis
Address [1] 302727 0
The Centre for Mental Health, The Melbourne School of Population and Global Health, The University of Melbourne, Victoria, 3010,
Country [1] 302727 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303373 0
The University of Melbourne Medicine and Dentistry Human Ethics Sub-Committee,
Ethics committee address [1] 303373 0
University of Melbourne
Parkville
Victoria
3010
Ethics committee country [1] 303373 0
Australia
Date submitted for ethics approval [1] 303373 0
Approval date [1] 303373 0
03/04/2019
Ethics approval number [1] 303373 0

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.
Trial website
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 93442 0
Prof Jane Pirkis
Address 93442 0
The University of Melbourne
Melbourne School of Population and Global Health
Centre for Mental Health
Level 4/ 207 Bouverie St
Carlton Victoria 3053
Country 93442 0
Australia
Phone 93442 0
+613 8344 0655
Fax 93442 0
Email 93442 0
j.pirkis@unimelb.edu.au
Contact person for public queries
Name 93443 0
Dr Maria Ftanou
Address 93443 0
The University of Melbourne
Melbourne School of Population and Global Health
Centre for Mental Health
Level 4/ 207 Bouverie St
Carlton Victoria 3053
Country 93443 0
Australia
Phone 93443 0
+613 8344 0655
Fax 93443 0
Email 93443 0
mftanou@unimelb.edu.au
Contact person for scientific queries
Name 93444 0
Dr Maria Ftanou
Address 93444 0
The University of Melbourne
Melbourne School of Population and Global Health
Centre for Mental Health
Level 4/ 207 Bouverie St
Carlton Victroria 3053
Country 93444 0
Australia
Phone 93444 0
+613 8344 0655
Fax 93444 0
mftanou@unimelb.edu.au
Email 93444 0
mftanou@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


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.