Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000553572
Ethics application status
Approved
Date submitted
25/03/2024
Date registered
1/05/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
1/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
COMPAS: Checking on mental health, providing alternatives to suicide
Scientific title
COMPAS (Checking on mental health, providing alternatives to suicide): Effect of a telehealth intervention on suicidality in first-year university students
Secondary ID [1] 311821 0
2032058
Universal Trial Number (UTN)
Trial acronym
COMPAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 333351 0
Mental health 333352 0
Condition category
Condition code
Mental Health 330031 330031 0 0
Suicide
Mental Health 330032 330032 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telehealth intervention for people identified at risk of suicidal behaviour in the future, Telehealth includes safety planning, assessment, and referral.

We have developed a multivariable algorithm, embedded in an online survey, that accurately identified individuals at increased risk of suicidal behaviour within the next 12 months. We work with our clinical psychology trainees to proactively reach out to these people to offer a telehealth intervention comprising risk assessment, safety planning, and linking with appropriate resources.

In the telehealth intervention, clinical trainees will talk with at risk students one-on-one (via phone or text) to determine their current needs. All students will complete safety planning. Resources and supports offered vary based on student need. Examples include linking in with student clubs and societies, facilitating visits to the GP for medication or a mental health care plan, and in rare cases encouraging students to attend to the emergency department. Phone calls average 30 minutes in duration. We aim to contact students within one hour of survey completion.

We will invite all first-year students across the universities to participate in an online survey, administered using Qualtrics, accessible on any smart device. To recruit participants we will:

1. Embed invitations to participate in Orientation activities, encouraging students to complete the screening survey as a normalised part of the orientation process;
2. Use flyers and present talks at information sessions during Orientation week;
3. Market the study on social media, digital screens, videos, and lecture theatre screens across campus;
4. Present in lectures, and post notices on Blackboard, for mandatory first year lectures;
5. Work with our Partner Organisations to host mental health awareness events on campus;
6. Provide regular updates of our progress with the project to participating universities.

Participants will respond to a range of questions regarding mental health and wellbeing. Items from the CIDI screener are used to assess psychological disorders (e.g., major depressive disorder, bipolar disorder, generalised anxiety disorder, panic disorder, conduct disorder, ADHD, eating disorder, alcohol/substance use disorders). Items from well-validated measures are used to assess suicide risk and protective factors: Physical health/health behaviours; Alcohol/drug use; Sexual orientation; Adverse childhood experiences, Sexual and physical abuse; Bullying, Recent stressful events; Academic stress; Religiosity, Spirituality; Family/peer support; Reasons for living. We will include the Acquired Capability for Suicide Questionnaire assessing fearlessness of death, pain tolerance, and perceived ability to take one’s life, and the 10-item Interpersonal Needs Questionnaire to assess perceived burdensomeness and thwarted belongingness, key theoretical components underlying suicide. The survey will take approximately 20 minute to complete..

All students will receive a comprehensive list of searchable local and national mental health resources, including resources for diverse groups of students. Examples of these include: Lifeline, Beyond Blue, University counselling services, drug and alcohol services etc. They will also have free access to an online emotion regulation program developed by CI Hasking and Prof James Gross from Stanford University. This online program contains 5 modules: 1. introduction to emotion regulation; 2. drawing your attention; 3. how we think is how we feel; 4. taking action and putting it all together; and 5. summary guide and feedback. The modules are focused on cognitive reappraisal as the key emotion regulation strategy and include text, videos, worksheets, and online exercises. This is self-paced and non-guided.

Students reporting suicide plan or suicide attempt in the last 12 months will additionally be directed to the BeyondNow smartphone safety planning App, ensuring no wait time to online support. Students can freely download the App to their phone and progress through a series of safety planning questions:

1. My warning signs
2. Things I can do to make my space safe
3. My reasons to live
4. Things I can do by myself
5. People and places I can connect with
6. People I can talk or yarn to
7. Professional support

Students can do this on their own or in conjunction with someone else (eg a friend, a therapist). Students can download their completed plan to their phone and update it any time. They can also share their plan with someone else. Completion time will vary depending on how much detail students enter into their plan.

Master of Clinical Psychology trainees undergo a 2-day manualised training program (half online modules, half face-to-face) that includes: information about COMPAS values and the evidence-base; adopting a person-centred approach to suicide prevention; talking compassionately with students in distress; safety planning and referral; and self-care. This training is delivered at least one week before recruitment starts. Clinical training was originally developed in collaboration with Lifeline WA, who will continue to provide input on training materials. Training is delivered by the research team or a trained clinician at sites interstate. Online module will be developed by the research team to ensure fidelity of training across sites. Clinical trainees will receive fortnightly 1 hour group supervision, as well as on-call support, for the duration of the call period (6 months each year). Supervision will include discussion of the calls (eg case review), individualised feedback for trainees, and review of referral pathways.

In conjunction with headspace we will also deliver free online workshops for supervisors, offering professional development in current approaches to suicide assessment and prevention, and developing a professional network of staff working on suicide prevention in university settings. These will include the headspace workshops: Real Talk (1 hour) - A presentation that builds the capacity of all university staff to engage in relevant conversations around mental health, including introducing the NIP it in the bud framework; what to Notice, how to Inquire and what supports to Provide someone experiencing mental health difficulties; Real Talk 2 in practice (2 hours) - An interactive session that takes a deep dive into case studies to build on the knowledge and skills from Real Talk 1 to engage in conversations and offer a variety of supports relevant to individuals at your university.; Responding to suicide (90 minutes) - This session focuses on the planning and response phases of postvention activities following a suicide, including guiding principles of postvention and immediate responses; Recovery after suicide (90 minutes) - This session focuses on the recovery phase of postvention, to support all staff to engage in activities to build mentally healthy universities following a suicide. This session is appropriate regardless of whether your university has been impacted by a suicide previously.

This is a 5 year project with a 6 month call period delivered to each incoming group of first-year university students
Intervention code [1] 328269 0
Prevention
Comparator / control treatment
In the first 2 years of the study we will collect baseline and 1 year follow up data that will be used to refine the algorithm, but also be used as a no-treatment control against which to evaluate the intervention. Although data are yet to be collected, at the time of analysis this will serve as a retrospective control. This cohort will receive a comprehensive list of searchable local and national mental health resources, including resources for diverse groups of students. Examples of these include: Lifeline, Beyond Blue, University counselling services, drug and alcohol services etc. They will also have free access to an online emotion regulation program developed by CI Hasking and Prof James Gross from Stanford University. This online program contains 5 modules: 1. introduction to emotion regulation; 2. drawing your attention; 3. how we think is how we feel; 4. taking action and putting it all together; and 5. summary guide and feedback. The modules are focused on cognitive reappraisal as the key emotion regulation strategy and include text, videos, worksheets, and online exercises. This is self-paced and non-guided.
Control group
Historical

Outcomes
Primary outcome [1] 337785 0
Suicide plans and/or attempts will be assessed as a composite outcome
Timepoint [1] 337785 0
Baseline, 4 weeks, one year follow-up post baseline
Primary outcome [2] 338066 0
Depression
Timepoint [2] 338066 0
Baseline, one year follow-up post baseline
Primary outcome [3] 338067 0
Anxiety
Timepoint [3] 338067 0
Baseline, one year follow-up post baseline
Secondary outcome [1] 433326 0
Student retention
Timepoint [1] 433326 0
Baseline, one year follow-up post baseline
Secondary outcome [2] 433327 0
Academic performance
Timepoint [2] 433327 0
Baseline, one year follow-up post baseline

Eligibility
Key inclusion criteria
Student enrolled at an Australian university in their first year of study.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
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
Other
Other design features
Outcomes for the intervention group will be compared to a historical control group who did not receive the intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Effectiveness on outcome measures: We will retrospectively fit the algorithm to data provided by students in Yrs 1-2, as a historical control to establish whether COMPAS-S confers additional benefit over existing approaches (e.g., Beyond Now). A hierarchical binary logistic regression will test the utility of the intervention [cohort (COMPAS-S vs. Control) by algorithm outcome (at risk vs. not at risk)] on the outcome variables (suicidal behaviour, depression, anxiety, academic outcomes). Lifetime and 12-month suicidal behaviour at baseline will be entered as covariates.

Generalised linear mixed models will be used to test proposed moderators of the relationship between receiving COMPAS-S and all outcomes. Fixed (e.g., geographic location, university size) and random effects will be included to account for clustering within universities and states. Using 1000 simulations in the Interaction PoweR package confirms we are powered (1-ß = 1.0) to detect small-medium interaction effects. Mediational analyses testing direct and indirect effects will assess the effect of our proposed mechanisms of change. Tests of indirect effects will be conducted with bias-corrected bootstrapping with 5,000 resampling draws, assessing effects at 95% confidence intervals. To achieve 1-ß = .8, with small effect sizes, 462 participants are required to test indirect effects..

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
7/02/2028
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316157 0
Government body
Name [1] 316157 0
National Health and Medical Research Council
Country [1] 316157 0
Australia
Funding source category [2] 316158 0
Charities/Societies/Foundations
Name [2] 316158 0
BeyondBlue
Country [2] 316158 0
Australia
Funding source category [3] 316159 0
Charities/Societies/Foundations
Name [3] 316159 0
Lifeline WA
Country [3] 316159 0
Australia
Funding source category [4] 316160 0
Charities/Societies/Foundations
Name [4] 316160 0
Headspace
Country [4] 316160 0
Australia
Funding source category [5] 316161 0
Government body
Name [5] 316161 0
Department of Health WA
Country [5] 316161 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 318337 0
University
Name [1] 318337 0
Deakin University
Address [1] 318337 0
Country [1] 318337 0
Australia
Secondary sponsor category [2] 318338 0
University
Name [2] 318338 0
Harvard Medical School
Address [2] 318338 0
Country [2] 318338 0
United States of America
Secondary sponsor category [3] 318339 0
University
Name [3] 318339 0
Massey University
Address [3] 318339 0
Country [3] 318339 0
New Zealand
Secondary sponsor category [4] 318340 0
University
Name [4] 318340 0
Australian National University
Address [4] 318340 0
Country [4] 318340 0
Australia
Secondary sponsor category [5] 318341 0
University
Name [5] 318341 0
University of New South Wales
Address [5] 318341 0
Country [5] 318341 0
Australia
Other collaborator category [1] 282988 0
Government body
Name [1] 282988 0
Department of Health WA
Address [1] 282988 0
Country [1] 282988 0
Australia
Other collaborator category [2] 282989 0
Charities/Societies/Foundations
Name [2] 282989 0
BeyondBlue
Address [2] 282989 0
Country [2] 282989 0
Australia
Other collaborator category [3] 282990 0
Charities/Societies/Foundations
Name [3] 282990 0
Lifeline WA
Address [3] 282990 0
Country [3] 282990 0
Australia
Other collaborator category [4] 282991 0
Charities/Societies/Foundations
Name [4] 282991 0
Headspace
Address [4] 282991 0
Country [4] 282991 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314987 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 314987 0
Ethics committee country [1] 314987 0
Australia
Date submitted for ethics approval [1] 314987 0
23/04/2024
Approval date [1] 314987 0
02/07/2024
Ethics approval number [1] 314987 0
HRE2024-0356

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

Contacts
Principal investigator
Name 133330 0
Prof Penelope Hasking
Address 133330 0
School of Population Health, Curtin University, Kent St, Bentely, 6102, WA
Country 133330 0
Australia
Phone 133330 0
+61 0892663437
Fax 133330 0
Email 133330 0
[email protected]
Contact person for public queries
Name 133331 0
Penelope Hasking
Address 133331 0
School of Population Health, Curtin University, Kent St, Bentely, 6102, WA
Country 133331 0
Australia
Phone 133331 0
+61 0892663437
Fax 133331 0
Email 133331 0
[email protected]
Contact person for scientific queries
Name 133332 0
Penelope Hasking
Address 133332 0
School of Population Health, Curtin University, Kent St, Bentely, 6102, WA
Country 133332 0
Australia
Phone 133332 0
+61 0892663437
Fax 133332 0
Email 133332 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
Only de-identified aggregate data will be shared upon reasonable request


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.