Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000489998p
Ethics application status
Submitted, not yet approved
Date submitted
7/11/2019
Date registered
20/04/2020
Date last updated
20/04/2020
Date data sharing statement initially provided
20/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Black Dog Institute (BDI) Gatekeeper program non-inferiority trial
Scientific title
Non-inferiority trial of Black Dog Institute (BDI) online gatekeeper training and Question Persuade Refer (QPR) online gatekeeper training for Australian adults.
Secondary ID [1] 299742 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide Prevention 315095 0
Condition category
Condition code
Mental Health 313428 313428 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BDI gatekeeper program is an interactive online program taking approximately one hour to complete. The structure and content were designed in consultation with clinicians, researchers, and people with a lived experience of suicide. Training content is primarily delivered in the form of acted scenarios portraying interactions between an individual experiencing thoughts of suicide and a person providing support. Through watching these videos and accompanying text descriptions, learners are taught to recognise the signs of suicide, have a conversation with the person, and provide help to the person. A fourth component of BDI’s program involves advice on self-care.

At any point during the training, learners can complete a ‘challenge’ component of the course. The challenge involves selecting one of three possible character-based scenarios describing someone who might be having thoughts of suicide. Individuals then answer a series of questions about the appropriate actions to take to approach and provide support.



Intervention code [1] 316006 0
Prevention
Comparator / control treatment
Question Persuade Refer (QPR) online training is a one hour program that aims to provide participants with the knowledge and skills to identify warning signs that someone may be suicidal, confidence to talk to them about suicidal thoughts, and connect them with professional care. The program covers common myths and misconceptions about suicide, warning signs of suicide (direct verbal, indirect verbal, behavioural, situational), how to ask the suicide question (direct and less direct methods), how to persuade someone to stay alive, and how to refer individuals to help.
Control group
Active

Outcomes
Primary outcome [1] 321908 0
Ability to recognise signs of suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [1] 321908 0
Two weeks after completing the pre-training survey (which is completed immediately before commencing the online training module)
Primary outcome [2] 322183 0
Ability to ask someone directly about suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [2] 322183 0
Two weeks after completing the pre-training survey (which is completed immediately before commencing the online training module)
Primary outcome [3] 322184 0
Ability to have a conversation with someone about their thoughts of suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [3] 322184 0
Two weeks after completing pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [1] 376648 0
Attitudes towards professional help-seeking (assessed with a modified version of the Attitudes Towards Professional Help-Seeking Scale)
Timepoint [1] 376648 0
Two weeks after completing pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [2] 376649 0
Knowledge of appropriate responses to suicide (assessed with a modified version of the Suicide Intervention Response Inventory)
Timepoint [2] 376649 0
Two weeks after completing pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [3] 376650 0
Actions towards someone suspected of being suicidal (assessed with a series of open-ended questions designed specifically for this study)
Timepoint [3] 376650 0
Two weeks after completing pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [4] 377607 0
Ability to intervene safely and constructively will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [4] 377607 0
Two weeks after completing pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [5] 377608 0
Ability to work with someone to keep them safe from suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [5] 377608 0
Two weeks after completing the pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [6] 377609 0
Ability to support a person to seek professional help will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [6] 377609 0
Two weeks after completing the pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [7] 377634 0
Ability to recognise signs of suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [7] 377634 0
Three months after completing the pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [8] 377635 0
Ability to ask someone directly about suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [8] 377635 0
Three months after completing the pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [9] 377636 0
Ability to have a conversation with someone about their thoughts of suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [9] 377636 0
Three months after completing the pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [10] 377637 0
Ability to intervene safely and constructively will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [10] 377637 0
Three months after completing the pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [11] 377638 0
Ability to work with someone to keep them safe from suicide will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [11] 377638 0
Three months after completing the pre-training survey (which is completed immediately before commencing the online training module)
Secondary outcome [12] 381342 0
Ability to support a person to seek professional help will be assessed by online questionnaire (Question, Persuade, Refer (QPR) training program questionnaire).
Timepoint [12] 381342 0
Three months after completing the pre-training survey (which is completed immediately before commencing the online training module)

Eligibility
Key inclusion criteria
Participation is open to all Australian residents 18 years old and over. Participants are required to have sufficient English literacy skills and access to a computer, smart phone, or tablet in order to complete the training and surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Yes, simple randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To test that there is no difference between the two programs (i.e. non-inferiority), 170 patients are required to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will be above the non-inferiority limit of -5. We have boosted the required sample size to allow for participant attrition between measurement points: 30% at time 2, and 25% at time 3, bringing the initial sample size to 276.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2020
Actual
Date of last participant enrolment
Anticipated
30/05/2020
Actual
Date of last data collection
Anticipated
30/08/2020
Actual
Sample size
Target
276
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304217 0
Charities/Societies/Foundations
Name [1] 304217 0
Buxton Foundation
Country [1] 304217 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
The University of New South Wales, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 304452 0
Charities/Societies/Foundations
Name [1] 304452 0
Black Dog Institute
Address [1] 304452 0
Hospital Rd, Randwick NSW 2031
Country [1] 304452 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304678 0
University of New South Wales HREC
Ethics committee address [1] 304678 0
Ethics committee country [1] 304678 0
Australia
Date submitted for ethics approval [1] 304678 0
17/02/2020
Approval date [1] 304678 0
Ethics approval number [1] 304678 0

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

Contacts
Principal investigator
Name 97830 0
Dr Fiona Shand
Address 97830 0
Black Dog Institute
Hospital Road, Randwick
NSW 2031
Country 97830 0
Australia
Phone 97830 0
+612 9382 4530
Fax 97830 0
Email 97830 0
[email protected]
Contact person for public queries
Name 97831 0
Banafsheh Moradmand Badie
Address 97831 0
Black Dog Institute
Hospital Road, Randwick
NSW 2031
Country 97831 0
Australia
Phone 97831 0
+612 9382 4530
Fax 97831 0
Email 97831 0
[email protected]
Contact person for scientific queries
Name 97832 0
Banafsheh Moradmand Badie
Address 97832 0
Black Dog Institute
Hospital Road, Randwick
NSW 2031
Country 97832 0
Australia
Phone 97832 0
+612 9382 4530
Fax 97832 0
Email 97832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.