Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001330235
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
7/08/2018
Date last updated
7/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Suicide Prevention Education for the Public: How effective is Addressing the Bystander Effect through the Bystander Intervention Model in increasing knowledge, confidence and intent to intervene?
Scientific title
The Efficacy of Online Suicide Prevention Education for the Public Addressing the Bystander Effect through the Bystander Intervention Model in increasing knowledge, confidence and intent to intervene: An RCT.
Secondary ID [1] 295650 0
Nil known.
Universal Trial Number (UTN)
U1111-1217-9666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide. 308986 0
Condition category
Condition code
Mental Health 307889 307889 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, 'Bystander Intervention Model Performance Scale' (BIMPS), hypothetical scenario of someone presenting with suicide risk, 'Confidence and Intent to Intervene Scale' (CITIS), education PDF, BIMPS time 2, CITIS time 2, Manipulation Check Questions asking how much the education information aligned with the BIM, debrief page. The total questionnaire takes approx. 30-45 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.
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.
Intervention code [1] 301965 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] 306862 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. This measure was adapted to suit a scenario of suicide risk. The adapted measure was assessed for reliability and validity in the current study. With a sample of 281 participants, it was found to have good internal consistency and convergent validity.
Timepoint [1] 306862 0
Immediately Pre-intervention.
Immediately Post-intervention (primary endpoint).
6-month follow-up.
Secondary outcome [1] 349965 0
Mean Confidence and Intent to Intervene Scale Score.
This scale was specifically designed for the currents study to assess participants' level of confidence and intent to intervene in a hypothetical scenario involving suicide risk. It was assessed for reliability and validity in the current study. With a sample of 281 participants, it was found to have good internal consistency and convergent validity.
Timepoint [1] 349965 0
Immediately Pre-intervention.
Immediately Post-intervention.
6-month follow-up.

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.
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


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study required a minimum 64 participants per group to gain sufficient power (optimally .80) and a large effect size (optimally a Cohen’s d of .50) at alpha .05 (Cohen, 1992). As the study involved factor analysis however, the study aimed to recruit at least 300 participants for robust analysis and interpretation. SPSS was used to analysis quantitative data exported from qualtrics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
31/12/2017
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
300
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300230 0
University
Name [1] 300230 0
Australian Catholic Univeristy
Country [1] 300230 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Rd
Banyo QLD 4014
Country
Australia
Secondary sponsor category [1] 299645 0
Individual
Name [1] 299645 0
Karien Hill
Address [1] 299645 0
Australian Catholic University
1100 Nudgee Rd
Banyo QLD 4014
Country [1] 299645 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301053 0
ACU Human Research Ethics Committee
Ethics committee address [1] 301053 0
1100 Nudgee Rd, Banyo 4014
Ethics committee country [1] 301053 0
Australia
Date submitted for ethics approval [1] 301053 0
03/04/2017
Approval date [1] 301053 0
28/04/2017
Ethics approval number [1] 301053 0
2016-281E

Summary
Brief summary
PURPOSE:
The aim of the study is to evaluate whether a BIM-guided factsheet about suicide prevention can improve participants’ knowledge, confidence and intent to intervene more than a standard condition when presented with a peer at risk of suicide.
HYPOTHESIS:
A public suicide prevention strategy which addresses the BIM will be more effective at increasing knowledge, confidence and intent to intervene when presented with someone at risk of suicide than a standard condition which does not address the BIM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85722 0
Dr Carina Chan
Address 85722 0
Australian Catholic University
1100 Nudgee Rd
Banyo 4014
Country 85722 0
Australia
Phone 85722 0
+61 7 3861 6093
Fax 85722 0
Email 85722 0
[email protected]
Contact person for public queries
Name 85723 0
Karien Hill
Address 85723 0
Australian Catholic University
1100 Nudgee Rd
Banyo QLD 4014
Country 85723 0
Australia
Phone 85723 0
+61402 437 210
Fax 85723 0
Email 85723 0
[email protected]
Contact person for scientific queries
Name 85724 0
Karien Hill
Address 85724 0
Australian Catholic University
1100 Nudgee Rd
Banyo QLD 4014
Country 85724 0
Australia
Phone 85724 0
+61402 437 210
Fax 85724 0
Email 85724 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
No additional documents have been identified.