Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000289415
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
7/03/2016
Date last updated
17/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Ripple Effect: Help us beat rural suicide
Scientific title
The Ripple Effect : A digital intervention to reduce the stigma associated with a personal experience in the Australian rural community
Secondary ID [1] 288597 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 297740 0
Suicide 297741 0
Condition category
Condition code
Mental Health 297923 297923 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Ripple Effect involves the development of a sustained, flexible and planned digital intervention, implemented at a local population level, to prompt change across the knowledge, attitudinal and behavioural components of self-stigma and perceived-stigma experienced by males aged 30-64 years from the community of farming with a personal experience of suicide. In recognising that suicide affects a broad range of the population, no adult will be excluded from participating in the Ripple Effect, However, the male target group will be the primary focus.

THE RIPPLE EFFECT DEVELOPMENT TEAM

The Ripple Effect has been developed by the National Centre for Farmer Health, Deakin University, the Victorian Farmers Federation, AgChatOZ, the Mental Illness Fellowship of North Queensland, Sandpit and Western District Health Service. The development of the Ripple Effect has been guided by a Steering Group comprising 15 health professionals (psychologists, social workers, nurses), researchers (specialising in farmer health and behavioural science), farming industry professionals, digital designers, stigma experts and farming community members with an experience of suicide. All content has been reviewed by a psychologist.

The Chief Investigator of the Ripple Effect is Associate Professor Dr Susan Brumby, Director of the National Centre for Farmer Health (Ph D, RN. RM., Dip Farm. M’Ment, Grad Dip Women’s Studies, Master Health Management, Certificate IV (Workplace training and assessment) MRCNA, ACHSE, ARLF). Dr Brumby has 0ver 30 years experience in rural health and wellbeing.

The Ripple Effect Research Fellow and Senior Investigator, Alison Kennedy (PhD, BBSc(Honours), PostGradDip(Criminology)) has six years of experience in rural mental health.

THE RIPPLE EFFECT INTERVENTION

The Ripple Effect intervention will run over a period of 8 months, preceded by a 6 week pilot program.

Participants will access the Ripple Effect website where they will be required to read a Participant Information Form and complete a Consent Form before being able to register to participate in the Ripple Effect. It will be emphasised that the website is not designed for crisis response and information on seeking crisis support will be provided (information about crisis services continues to be provided on every page). Upon registration, participants will complete the Stigma of Suicide Scale (SOSS) and the Literacy of Suicide Scale (LOSS)(pre-test). The Ripple Effect goal of reducing suicide stigma will be achieved in 3 ways:

1. Shared stories and experiences - participants will have the opportunity to share aspects of the own story as well as read other people's messages (collected via hard copy and digital Ripple Effect postcards). Postcard messages will be screened, before being digitised and included on the website, to ensure they meet the Mindframe media guidelines for talking about suicide. A series of digital stories—created by members of the farming community with an experience of suicide during a professionally facilitated workshop—will also be presented to participants. These stories highlight experiences of suicide stigma and how this can be overcome.

2. Information/education - participants will answer a series of questions about their experience of suicide as they progress through the website (for example, have you spoken to anyone about your experience?), allowing for both staged and curated information to be presented to them. This information covers five topics:
a) Knowledge about suicide: Including information about risk/protective factors, warning signs, precipitating events, understanding suicide attempts/suicide thoughts and suicide stigma.
b) Everyone's experience is different: Emphasising the variability of suicide experience and including information on Culturally and Linguistically Diverse (CALD) people, Aboriginal and Torres Strait Islander people, sexuality and gender diversity, and disability/illness/ageing and how these differences can affect suicide risk and how we respond to this.
c) Talking about suicide: Emphasising the importance of talking safely about suicide to reduce risk and how this will vary depending on a person's experience of suicide (either bereaved by suicide, attempted suicide, had thoughts of suicide, cared for someone who has attempted suicide or been touched by suicide in some other way). Includes information on starting and managing conversations with people in distress, crisis response, avoiding judgement, preparation and knowledge of resources and self care. Includes guidance on becoming involved in suicide prevention activities and talking about suicide with the broader community.
d) Recognising and maximising resources to help you and others: Encourages people to be positive and proactive in seeking support, knowing what is available and identifying and overcoming barriers to support. Provides information on caring and supporting others.
e) Knowing what's needed for keeping well: Providing information on maintaining physical, emotional, intellectual and spiritual health and setting personal goals to achieve these. Participants will be asked to set personal goals and will have the opportunity to self-evaluate their achievements.

For each of the five topics, all participants will be presented with core content. This core content will take approximately 3 hours in total (across the combined topic areas) to complete. Additional tailored information will be presented depending on the nature of their experience of suicide.

3. Resources/support services - participants will be provided with an extensive list of resources and support services with national, state and local availability.

Participant involvement in the Ripple Effect is self-paced to a maximum of 12-weeks. Participants are able to move in and out of the intervention as it suits them. The nature of the registration system allows for people to pick up where they left off. A personal profile page allows participants to identify their progress through the intervention. Participants will receive an email/SMS reminder if they have not logged in to the Ripple Effect after a certain period of time (determined by the participant).

On completion of all of the core content, participants will again complete the Stigma of Suicide Scale (SOSS) and the Literacy of Suicide Scale (LOSS)(post-test).

Participants will be asked to identify their willingness to participate in a semi-structured follow-up interview about their experience participating in the Ripple Effect. 10 qualitative interviews will be conducted by a researcher with doctoral-level experience in interviewing farmers with an experience of suicide.
Intervention code [1] 293992 0
Behaviour
Intervention code [2] 294021 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297438 0
Level of self-stigma relative to an experience of suicide. Self-stigma will be measured using an adapted short-form of the Stigma of Suicide Scale (SOSS) (Batterham, Callear and Christensen, 2013). This measure will be restricted to those participants who report an experience of suicide involving their own suicidal thoughts or behaviours.
Timepoint [1] 297438 0
Pre-intervention: Immediately following registration on the Ripple Effect website.
Post-intervention: Upon completion of all of the Ripple Effect website core content.

Participants who begin the intervention but do not complete the core component will also be asked to complete an exit SOSS (short form) after 12 weeks from initial completion of the SOSS and LOSS.
Primary outcome [2] 297478 0
Level of perceived-stigma relative to an experience of suicide. Perceived-stigma will be measured using an adapted short-form of the Stigma of Suicide Scale (SOSS) (Batterham, Callear and Christensen, 2013). This measure will be completed by all participants.
Timepoint [2] 297478 0
Pre-intervention: Immediately following registration on the Ripple Effect website.
Post-intervention: Upon completion of all of the Ripple Effect website core content.
Secondary outcome [1] 321053 0
Suicide literacy will be measured using the Literacy of Suicide Scale (LOSS) (Batterham, Callear and Christensen, 2013). This measure will be completed by all participants.
Timepoint [1] 321053 0
Pre-intervention: Immediately following registration on the Ripple Effect website.
Post-intervention: Upon completion of all of the Ripple Effect website core content.

Participants who begin the intervention but do not complete the core component will also be asked to complete an exit LOSS after 12 weeks from initial completion of the SOSS and LOSS.

Eligibility
Key inclusion criteria
Includes adults from the rural community across Australia. Only participants who self- identify as having a lived experience of suicide (attempted suicide, been bereaved by suicide, cared for someone who has attempted suicide, personally experienced suicidal thoughts, or have been touched by suicide in another way) will be included in the intervention, as our preliminary results indicate these are the highest risk group for heightened self-stigma and perceived-stigma.
Minimum age
18 Years
Maximum age
64 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Males and females below the age of 18 are excluded.

Although not excluded from the intervention, females and all males who are between 18 and 30 years or older than 64 years will not be the primary focus of the intervention and will be included in secondary data analysis.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All participants will be presented with core content. Participants must be exposed to all of the core content in order to be considered part of the intervention. To compliment the core content, participants will be presented with personalised information dependent on the nature of their experience of suicide.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Ripple Effect will be evaluated through the use of nationally comparable scales—the Stigma of Suicide Scale short form (SOSS) and the 27-item Literacy of Suicide Scale (LOSS). The SOSS short form (primary outcome measure) and LOSS (secondary outcome measure) will be administered at entry to, and following completion of The Ripple Effect as an exit survey. The comparison of pre and post data will monitor both the stigma and literacy variables of participants in response to the intervention.
The Ripple Effect intervention will be undertaken flexibly—participants can self-pace over a maximum 12-week period to complete core components. Participants who begin the intervention but do not complete the core component will also be asked to complete an exit SOSS (short form) and LOSS. Analysis will be undertaken on the full analysis set (FAS) using intention to treat principle (ITT). This will be complemented with analysis of a per protocol set (PPS) that only includes those who have completed the core components (i.e. completers). Comparing the ITT with the PPS will provide a sensitivity analysis for the SOSS and LOSS. Paired t-tests will be used to assess the effect of the intervention over time (pre- and post-Ripple Effect). Based upon a small effect size (d=0.2), power of 0.80 and significance level of 5% (a=0.05), and allowing for 20% attrition, we will aim to recruit 473 participants. As was done by Taylor-Rodgers and Batterham (2014) the power calculation is conservative, as it does not account for repeated measures.
Supportive analysis of baseline data on the prevalence of both measured and self-reported indicators of suicide stigma (SOSS) and literacy (LOSS) will be compared with existing survey data to identify differences. Differences due to age and nature of personal experience of suicide will also be investigated.
Other secondary outcomes to be measured include interactions between suicide stigma and literacy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2016
Actual
30/06/2016
Date of last participant enrolment
Anticipated
28/02/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
473
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292943 0
Charities/Societies/Foundations
Name [1] 292943 0
beyondblue
Country [1] 292943 0
Australia
Primary sponsor type
University
Name
Deakin University/National Centre for Farmer Health
Address
1 Gheringhap Street
Geelong
Victoria 3220
Country
Australia
Secondary sponsor category [1] 291707 0
Commercial sector/Industry
Name [1] 291707 0
Sandpit
Address [1] 291707 0
64 North Terrace
Kent Town
South Australia 5067
Country [1] 291707 0
Australia
Secondary sponsor category [2] 291708 0
Other
Name [2] 291708 0
Victorian Farmers Federation
Address [2] 291708 0
Farrer House
Level 5, 24 Collins St
Melbourne, Victoria 3000
Country [2] 291708 0
Australia
Secondary sponsor category [3] 291709 0
Other
Name [3] 291709 0
AgChatOZ
Address [3] 291709 0
Tom Whitty
C/O Department of Economic Development, Jobs, Transport and Resources
Level 16
8 Nicholson Street
East Melbourne
Victoria, 3002
Country [3] 291709 0
Australia
Secondary sponsor category [4] 291710 0
Charities/Societies/Foundations
Name [4] 291710 0
Mental Illness Fellowship North Queensland
Address [4] 291710 0
59a Cambridge St
Vincent
Queensland 4814
Country [4] 291710 0
Australia
Secondary sponsor category [5] 291711 0
Hospital
Name [5] 291711 0
Western District Health Service
Address [5] 291711 0
20 Foster Street
Hamilton
Victoria 3300
Country [5] 291711 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294448 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 294448 0
Ethics committee country [1] 294448 0
Australia
Date submitted for ethics approval [1] 294448 0
22/05/2015
Approval date [1] 294448 0
06/07/2015
Ethics approval number [1] 294448 0
2015-136

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63414 0
A/Prof Susan Brumby
Address 63414 0
National Centre for Farmer Health
PO Box 283
Hamilton
Victoria 3300
Country 63414 0
Australia
Phone 63414 0
+61 3 5551 8460
Fax 63414 0
+61 3 5551 8267
Email 63414 0
[email protected]
Contact person for public queries
Name 63415 0
Alison Kennedy
Address 63415 0
National Centre for Farmer Health
PO Box 283
Hamilton
Victoria 3300
Country 63415 0
Australia
Phone 63415 0
+61 3 5551 8587
Fax 63415 0
+61 3 5551 8267
Email 63415 0
[email protected]
Contact person for scientific queries
Name 63416 0
Alison Kennedy
Address 63416 0
National Centre for Farmer Health
PO Box 283
Hamilton
Victoria 3300
Country 63416 0
Australia
Phone 63416 0
+61 3 5551 8587
Fax 63416 0
+61 3 5551 8267
Email 63416 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
Dimensions AIResearch protocol for a digital intervention to reduce stigma among males with a personal experience of suicide in the Australian farming community2016https://doi.org/10.1186/s12889-016-3874-3
EmbaseOnline assessment of suicide stigma, literacy and effect in Australia's rural farming community.2018https://dx.doi.org/10.1186/s12889-018-5750-9
EmbaseThe ripple effect: a digital intervention to reduce suicide stigma among farming men.2020https://dx.doi.org/10.1186/s12889-020-08954-5
N.B. These documents automatically identified may not have been verified by the study sponsor.