Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000043336
Ethics application status
Approved
Date submitted
7/12/2016
Date registered
10/01/2017
Date last updated
10/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mass media campaign material designed to prevent youth suicide: A randomised controlled trial
Scientific title
Mass media campaign material designed to prevent youth suicide: A randomised controlled trial among healthy young adults
Secondary ID [1] 290695 0
None
Universal Trial Number (UTN)
U1111-1190-6202
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 301242 0
emergency contraception 301243 0
mental health 301247 0
Condition category
Condition code
Mental Health 300999 300999 0 0
Suicide
Public Health 301006 301006 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aims
This study aims to build the evidence base for an effective public education campaign which raises community awareness of suicide and encourages help-seeking behaviour among vulnerable young people, without running the risk of causing distress or other forms of harm.

Research questions
This study aims to address two research questions
1) Do certain media messages have positive effects (e.g., improving knowledge about risk factors and warning signs, encouraging help-seeking)

2) Do certain media messages have negative effects (e.g., perpetuating myths about suicide, triggering suicidal thoughts
This study takes the form of a four-arm randomised controlled trial (three active suicide prevention intervention Community Service Announcements (CSAs) and one control group- an emergency contraception CSA) with three measurement occasions (pre-viewing, post-viewing, four -week follow-up). We will recruit 240 young people (aged 18-24). Recruitment will occur via a range of approaches including advertisements on noticeboards and websites. The young people who agree to participate will be randomly allocated to one of four conditions – viewing one of the three CSAs on suicide prevention or viewing the control emergency contraception CSA.

Each CSA was 30 seconds long and featured the same young people but had a different message. CSA 1: featured young people doing things to improve their mood and suicidal thinking. The main message was find what works for you. CSA2: featured young people discussing the importance of talking and concludes "talk to someone".CSA3 fetures young people overcoming suicidal thoughts and concludes that life gets better". The control CSA is about emergency contraception and lets young people know that the can access it at a pharmacy.

All viewing of CSAs was conducted undersupervsion and participant had to mark that the they viewed the CSA before the Time 2 survey was made available to them to complete.
CSA viewing

Each participant will view his or her allocated CSA on an individual ipad or laptop with headphones in a quiet room at their own health service.

Data collection
Data collection will occur at three time points (T1 pre-viewing, T2 immediately post-viewing &T3 1 month post viewing).

Randomisation
Upon consenting to participate in the study, participants are randomised at the individual level using computer generated randomisation. This gives each potential participant an equal chance of being assigned to watch each of the four CSAs. At the time of randomization researcher are unaware of which CSA participants will be randomly assigned to watch.
Intervention code [1] 296577 0
Prevention
Intervention code [2] 296578 0
Behaviour
Comparator / control treatment
Participants in the control arm will view an unrelated to CSA. All other conditions are the same as the intervention treatment. The control CSA is about emergency contraception
Control group
Active

Outcomes
Primary outcome [1] 300417 0
Changes in attitudes towards suicide as measured by The Questionnaire on Attitudes Towards Suicide (ATTS)(Renberg & Jacobsson, 2003): The 34-item ATTS asks respondents to indicate their level agreement with 34 suicide-related statements on a 5-point Likert scale from ‘agree completely’ to ‘agree not at all’. The ATTS will be used to gauge participants’ beliefs and attitudes about suicide. Suicide and Life-Threatening Behavior 33(1), 52-57.
Timepoint [1] 300417 0
Baseline and at 4 weeks post viewing of the CSA
Secondary outcome [1] 329937 0
A change in intentions to seek help as measured by an adapted version of the General Help Seeking Questionnaire (GHSQ) (Wilson et al. 2005. Measuring help seeking intentions: Properties of the General Help Seeking Questionnaire. Canadian Journal of Counselling, Vol. 39(1), 15-28.).

This questionnaire asks: If you were having a personal or emotional problem, how likely is it that you would seek help from the following people or services? eleven responses are provided: intimate partner, friend, parent, other family member, mental health professional, phone helpline, doctor, minister or religious leader, I would not seek help from anyone, I would seek help from another not listed above. Respondents rate the likelihood on a seven-point scale. We modified this scale by providing an additional three responses: online health chat rooms, online searches for health information, and social media. We also repeated the questionnaire twice asking the same question regarding recommending help for a male or female friend. The primary outcome is the questionnaire related to intentions to seek help for self.
Timepoint [1] 329937 0
Baseline and at 4 weeks post viewing of the CSA
Secondary outcome [2] 329938 0
A change in psychological distress as measured by the Kessler-10 scale (K10) (Kessler RC, Andrews G, Colpe LJ e t al . Short screening scales to monitor population prevalences and trends in non-specifi c psychological distress. Psychol Med 2002; 32:959 – 976).

The K10 is a ten item scale that asks about symptoms of psychological distress in the past four weeks documentary
Timepoint [2] 329938 0
Baseline and at 4 weeks post viewing of the CSA
Secondary outcome [3] 329939 0
A change in suicidality as measured by the Adult Suicide Ideation Questionnaire (ASIQ) (Reynolds W.M. (1991). Psychometric characteristics of the Adult Suicidal Ideation Questionnaire in college students. Journal of Personality assessment, 56, 289-307)

The 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. It was chosen both for it’s potential to be used as an outcome measure and as a screener for the study.
Timepoint [3] 329939 0
Baseline and at 4 weeks post viewing of the CSA
Secondary outcome [4] 329940 0
A change in alcohol use as measured by The Alcohol Use Disorders Identification Test (AUDIT)(Babor, Higgins-Biddle, Saunders, & Monteiro, 2001): The AUDIT has three questions on alcohol consumption, three questions on drinking behaviour and dependence and four questions on the consequences or problems related to drinking. The Alcohol Use Disorders Identification Test, Guidelines for Use in Primary Care, (Second Edition ed.). Geneva: Department of Mental Health and Substance Dependence, Department of Mental Health and Substance Dependence.
Timepoint [4] 329940 0
At Baseline and four weeks post viewing the CSA
Secondary outcome [5] 329941 0
A change in risk taking behaviour as measured by The Risk Taking Behaviour Scale (RTBS)(Dohmen T et al., 2011): The RTBS is a one item measure that asks participant to rate their willingness to take risks. .Journal of the European Economic Association, 9(3), 522-550.
Timepoint [5] 329941 0
At baseline and four weeks post intervention
Secondary outcome [6] 329942 0
Changes in mood and distress as measured by The Brunel Mood Scale (BRUMS)(McNair, Lorr, & DopplemanmL., 1992; Terry, Lane, Lane, & Keohane, 1999): is a 24-item instrument that assesses current levels of mood and distress. Respondents are asked to describe the extent to which they feel ‘right now’ with respect to various descriptors, using a 5-point Likert scale from ‘not at all’ to ‘extremely’. This will be used to assess participants’ immediate levels of distress. Revised Manual for the Profile of Mood States. San Diego, CA: Educational and Industrial Testing Service.
Timepoint [6] 329942 0
At Baseline, immediately post viewing CSA and for weeks post viewing the CSA
Secondary outcome [7] 329943 0
Changes in actual help seeking as measured by the The Actual Help-Seeking Questionnaire (AHSQ)(Rickwood, Deane, Wilson, & Ciarrochi, 2005): The AHSQ is structured in a similar manner to the GHSQ but instead of asking respondents about their likelihood of seeking help from a range of sources it asks whether they have sought help from these sources in the past 2 weeks. The AHSQ will be used to assess actual help-seeking in the past 2 weeks. Australian e-Journal for the Advancement of Mental Health 4(3)
Timepoint [7] 329943 0
At Baselines and four weeks post viewing CSA
Secondary outcome [8] 329944 0
Changes in sexual attitudes as measured by The Brief Sexual Attitudes Scale (BSAS)(Hendrick, Hendrick, & Reich, 2006): The BSAS is made up of four subscales: Permissiveness, Birth Control, Communion, and Instrumentality It consist of 23 items and asks respondents to indicate their level of agreement with each statements on a 5-point Likert scale from ‘ strongly agree’ to ‘strongly disagree’. Journal of Sex Research, 43, 76-86.
Timepoint [8] 329944 0
At baseline and 4 weeks post intervention

Eligibility
Key inclusion criteria
18 -24 year old attending a university health service or a headspace centre
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
With the exception of participants attending one headspace centre, If a participant scores highly on the Adult Suicide Ideation Questionnaire they will be excluded from 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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. To answer the research question about the positive and negative effects of certain media messages, we will analyse changes in each outcome measure by treatment group and time.

Changes in attitudes towards suicide (as measured by the ATTS) will be used as the primary outcome measure. A linear regression analyses using scores on the ATTS 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
Completed
Date of first participant enrolment
Anticipated
Actual
16/06/2015
Date of last participant enrolment
Anticipated
Actual
15/12/2016
Date of last data collection
Anticipated
Actual
15/12/2016
Sample size
Target
240
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295125 0
Charities/Societies/Foundations
Name [1] 295125 0
Rotary Australia
Country [1] 295125 0
Australia
Primary sponsor type
Individual
Name
Prof. Jane Pirkis
Address
The Centre for Mental Health, The Melbourne School of Population and Global Health, The University of Melbourne, Victoria, 3010, Australia
Country
Australia
Secondary sponsor category [1] 293944 0
None
Name [1] 293944 0
Address [1] 293944 0
Country [1] 293944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296474 0
The Office of Researtch Integrity The University of Melbourne
Ethics committee address [1] 296474 0
Level 1 780 Elizabeth st Melbourne Victoria 2010
Ethics committee country [1] 296474 0
Australia
Date submitted for ethics approval [1] 296474 0
Approval date [1] 296474 0
27/05/2014
Ethics approval number [1] 296474 0
1341188
Ethics committee name [2] 296475 0
the Alfred hospital ethics comittee
Ethics committee address [2] 296475 0
55 Commercial Road Prahran Victoria 3181
Ethics committee country [2] 296475 0
Australia
Date submitted for ethics approval [2] 296475 0
19/08/2015
Approval date [2] 296475 0
02/09/2015
Ethics approval number [2] 296475 0
322/15

Summary
Brief summary
This study aims to build the evidence base for an effective public education campaign for young people. It involves the development and testing of content which will culminate in the production of four Community Service Announcements (CSAs) with different key messages, designed for television or cinema. 240 young people will be recruited from the general population and headspace, and randomly allocated to view one of the 3 suicide prevention intervention CSAs or a control CSA on accessing emergency contraception.
Participants will answer questions pre-viewing, post-viewing and four weeks later to permit an examination of several positive and negative outcomes. In addition to understanding the impact of three suicide CSAs this project provides a unique opportunity
to collect information about how well a CSA about emergency contraception may work at improving knowledge among young adults.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1302 1302 0 0
/AnzctrAttachments/371979-322-15 ETHICS COMMITTEE CERTIFICATE OF APPROVAL.pdf (Ethics approval)
Attachments [2] 1303 1303 0 0
/AnzctrAttachments/371979-1341188-28052014142314 Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 70974 0
Prof Jane Pirkis
Address 70974 0
Centre for Mental Health
School of Population and Global Health
University of Melbourne
level 4 207 Bouverie St Carlton Victoria 3000
Country 70974 0
Australia
Phone 70974 0
+613 8344 0655
Fax 70974 0
Email 70974 0
[email protected]
Contact person for public queries
Name 70975 0
Maria Ftanou
Address 70975 0
Centre for Mental Health
School of Population and Global Health
University of Melbourne
level 4 207 Bouverie St Carlton Victoria 3000
Country 70975 0
Australia
Phone 70975 0
+61383440655
Fax 70975 0
Email 70975 0
[email protected]
Contact person for scientific queries
Name 70976 0
Maria Ftanou
Address 70976 0
Centre for Mental Health
School of Population and Global Health
University of Melbourne
level 4 207 Bouverie St Carlton Victoria 3000
Country 70976 0
Australia
Phone 70976 0
+613 8344 0655
Fax 70976 0
Email 70976 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseInterventions for youth suicide and suicide-related behaviour: An update to a systematic review.2023https://dx.doi.org/10.1177/10398562231187972
N.B. These documents automatically identified may not have been verified by the study sponsor.