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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
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.
Secondary ID [1] 295646 0
None.
Universal Trial Number (UTN)
U1111-1217-9652
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide prevention 308984 0
Condition category
Condition code
Mental Health 307887 307887 0 0
Suicide

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 301963 0
Behaviour
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
Control group
Active

Outcomes
Primary outcome [1] 306860 0
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.
Timepoint [1] 306860 0
Post intervention only - immediately after.
Primary outcome [2] 306861 0
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.
Timepoint [2] 306861 0
Post intervention only - immediately after.
Secondary outcome [1] 349964 0
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.
Timepoint [1] 349964 0
Post Intervention Only - immediately after.

Eligibility
Key inclusion criteria
Males and females from general adult population.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
31/01/2019
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300227 0
University
Name [1] 300227 0
Australian Catholic University
Country [1] 300227 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Rd, Banyo QLD 4014
Country
Australia
Secondary sponsor category [1] 299638 0
Individual
Name [1] 299638 0
Karien Hill
Address [1] 299638 0
Australian Catholic University
1100 Nudgee Rd, Banyo QLD 4014
Country [1] 299638 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301050 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 301050 0
Ethics committee country [1] 301050 0
Australia
Date submitted for ethics approval [1] 301050 0
24/07/2018
Approval date [1] 301050 0
Ethics approval number [1] 301050 0

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

Contacts
Principal investigator
Name 85710 0
Dr Keong Yap
Address 85710 0
Australian Catholic University
Edward Clancy Building, 25A Barker Road, Strathfield, NSW 2135
Country 85710 0
Australia
Phone 85710 0
+61 2 9701 4574
Fax 85710 0
Email 85710 0
keong.yap@acu.edu.au
Contact person for public queries
Name 85711 0
Karien Hill
Address 85711 0
Australian Catholic University
1100 Nudgee Rd
Banyo QLD 4014
Country 85711 0
Australia
Phone 85711 0
+61402 437 210
Fax 85711 0
Email 85711 0
karien.hill@myacu.edu.au
Contact person for scientific queries
Name 85712 0
Karien Hill
Address 85712 0
Australian Catholic University
1100 Nudgee Rd
Banyo QLD 4014
Country 85712 0
Australia
Phone 85712 0
+61402 437 210
Fax 85712 0
Email 85712 0
karien.hill@myacu.edu.au

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.