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Trial registered on ANZCTR
Registration number
ACTRN12618001331224p
Ethics application status
Submitted, not yet approved
Date submitted
24/07/2018
Date registered
7/08/2018
Date last updated
7/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Promoting suicide prevention action planning in the community: A randomised controlled trial guided by the Bystander Intervention Model
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Scientific title
Promoting suicide prevention action planning in the community: A randomised controlled trial guided by the Bystander Intervention Model Assessing Risk Assessment and Protective Action Ability.
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Secondary ID [1]
295646
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None.
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Universal Trial Number (UTN)
U1111-1217-9652
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Suicide prevention
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Condition category
Condition code
Mental Health
307887
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0
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Suicide
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is Bystander Intervention Model (BIM)-informed suicide prevention education material. This material is a PDF factsheet teaching participants about suicide risk factors, warning signs and protective factors and teaching them how to intervene. This is provided in the online questionnaire of this study. Participants are provided with a link to the online questionnaire in the study advertisement. The questionnaire presents the following information in order: demographics, education PDF, hypothetical scenario of someone presenting with suicide risk, an open question asking how they would respond, Bystander Intervention Model Performance Scale (BIMPS), Manipulation Check Questions asking how much the education information aligned with the BIM, debrief page. The total questionnaire takes approx. 30 min to complete.
As stated, the intervention is only delivered once during the overall questionnaire. Adherence is assessed through timing how long participants spend on reading the page and asking a 5 point scale question: 'I read the factsheet carefully and in full' - 'strong disagree, disagree, neutral, agree, strongly agree'.
This factsheet was designed specifically for this study based on evidence-based, best practice guidelines in suicide risk assessment and intervention.
The factsheet is 8 pages - mostly graphics and bullet points - taking approx 10 min to read.
Participants are asked to provide a typed response of how they would respond to a hypothetical scenario of suicide risk after reading the sheet. Their response is then compared to a checklist of behaviours based on best practice guidelines. The total number of appropriate responses are then totalled and entered into SPSS as a total score on the 'Risk Assessment Ability Checklist' and 'Protective Action Ability Checklist' and differences between groups compared.
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Intervention code [1]
301963
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Behaviour
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Comparator / control treatment
This group will receive suicide prevention education material which is NOT BIM-informed and based on currently available information and delivered as above.
This sheet is compiled from readily available resources for the public from RUOK? and Sane: https://irp-cdn.multiscreensite.com/22b3e3c9/files/uploaded/RUOK_MobileTipSheet_HowToAsk_265x470_V1%5B2%5D.pdf
https://www.sane.org/mental-health-and-illness/facts-and-guides/fvm-mental-illness-basics
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Control group
Active
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Outcomes
Primary outcome [1]
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Mean suicide risk assessment ability score.
This score is derived from a checklist of evidence-based, best practice guidelines in suicide risk assessments. Participants' qualitative responses through an 'action plan' is manually compared to this checklist and rated 0 (not mentioned), 1 (mentioned in little detail) or 2 (mentioned in great detail) on each factor including for example asking about suicide ideation, asking about suicide plan, asking about mental health history, asking about social support. Each participants score on this checklist is then totalled and entered into SPSS to compare the mean scores between the experimental and control group.
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Assessment method [1]
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Timepoint [1]
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Post intervention only - immediately after.
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Primary outcome [2]
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Mean suicide risk protective action ability score.
This score is derived from a checklist of evidence-based, best practice guidelines in keeping a person at risk of suicide safe. Participants' qualitative responses through an 'action plan' is manually compared to this checklist and rated 0 (not mentioned), 1 (mentioned in little detail) or 2 (mentioned in great detail) on each factor including for example taking the person to see a Psychologist or taking them to hospital for further assessment and providing ongoing support. Each participants score on this checklist is then totalled and entered into SPSS to compare the mean scores between the experimental and control group.
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Assessment method [2]
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Timepoint [2]
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Post intervention only - immediately after.
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Secondary outcome [1]
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Mean Bystander Intervention Model Performance Scale Score. This is an adapted measure from a previously validated measure which assessed self-reproted bystander intervention in persons exposed to a scenario involving witnessing bullying or sexual harassment - the 'Bystander intervention in bullying and sexual harassment' Scale (Nickerson et al., 2014). The adapted measure has been validated by the author in a previous study with 281 participants were good internal consistency and congruent validity was found.
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Assessment method [1]
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Timepoint [1]
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Post Intervention Only - immediately after.
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Eligibility
Key inclusion criteria
Males and females from general adult population.
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Minimum age
18
Years
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Maximum age
No limit
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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
Previous bereavement by suicide.
Distressed by topic of suicide.
Having participated in previous study to this overall project.
Personal suicide ideation.
Aged under 18 years.
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Study design
Purpose of the study
Educational / counselling / training
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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)
Central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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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
Both qualitative and quantitative data will be collected. According to Francis et al. (2010), to reach saturation of ideas in qualitative data, approximately 12-17 participants per group are required. According to Cohen (1992), for quantitative data, to detect a moderate effect size between two independent sample means at an alpha level of .05, with power at .80, the study will require at least 64 participants in total. Qualtrics will record the length of time participants spent on reading the experimental factsheet. If participants’ time is 30+ seconds less than the average time it takes for pilot participants, their full response will be excluded from analysis. Further, Factor Analysis will be conducted on the BIMP measure below which will require at least 200 participants. To meet all of the aforementioned requirements, the study aims to recruit at least 250 participants.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/09/2018
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Actual
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Date of last participant enrolment
Anticipated
31/01/2019
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Actual
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Date of last data collection
Anticipated
31/01/2019
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Australian Catholic University
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Address [1]
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1100 Nudgee Rd, Banyo QLD 4014
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Australian Catholic University
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Address
1100 Nudgee Rd, Banyo QLD 4014
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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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Karien Hill
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Address [1]
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Australian Catholic University
1100 Nudgee Rd, Banyo QLD 4014
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Country [1]
299638
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Australian Catholic University Human Research Ethics Committee
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Ethics committee address [1]
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Australian Catholic University
1100 Nudgee Rd
BANYO QLD 4014
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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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24/07/2018
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Approval date [1]
301050
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Ethics approval number [1]
301050
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Summary
Brief summary
PURPOSE:
To compare the efficacy of Bystander Intervention Model-informed suicide prevention material with standard existing material in promoting appropriate suicide risk assessment and protective action in the general community according to best-practice to suicide prevention.
HYPOTHESES:
1. The experimental condition will have a significantly higher suicide risk assessment ability score than the standard condition.
2. The experimental condition will have a significantly higher suicide protective action ability score than the standard condition.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Keong Yap
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Address
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Australian Catholic University
Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
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Country
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Australia
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Phone
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+61 2 9701 4574
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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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Mrs Karien Hill
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Address
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Australian Catholic University
1100 Nudgee Rd
Banyo QLD 4014
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Country
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Australia
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Phone
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+61402 437 210
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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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Mrs Karien Hill
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Address
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Australian Catholic University
1100 Nudgee Rd
Banyo QLD 4014
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Country
85712
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Australia
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Phone
85712
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+61402 437 210
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Fax
85712
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Email
85712
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[email protected]
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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
No additional documents have been identified.
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