Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001156572
Ethics application status
Approved
Date submitted
3/09/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of mental health training on the confidence of university staff in supporting student mental health: a quasi-experimental trial
Scientific title
The impact of mental health training on the confidence of university staff in supporting student mental health: a quasi-experimental trial
Secondary ID [1] 312867 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Confidence in supporting student mental health 335006 0
Stigmatising attitudes towards mental health 335007 0
Mental health knowledge 335008 0
Behavioural responsiveness towards student mental health 335009 0
Psychological distress 335010 0
Condition category
Condition code
Mental Health 331521 331521 0 0
Anxiety
Mental Health 331522 331522 0 0
Depression
Mental Health 331523 331523 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was skills-based mental health training, 3-hours in duration and delivered online through interactive workshops (including interaction group discussions, short videos and workbooks to fill out) facilitated by experienced, independent clinicians. Each participant attends one single workshop. The workshops were adapted from previous mental health training for workplace managers (Gayed et al., 2019; Milligan-Saville et al., 2017) and tailored in partnership with representatives from the participating university to reflect the needs of staff within the faculty who had regular contact with students. The training comprised ten modules covering the following topics:
1. Acknowledgement of Country & Introductions 9 mins
2. Prevalence of mental illness 4 mins
3. Recognising changes in behaviour 11 mins
4. Disclosure of mental health conditions 14 mins
5. Approaching a conversation about mental health 10 mins
6. Help-seeking 4 mins
7. Practicing the conversation 40 mins
Break 5 mins
8. Self-harm and suicidality 32 mins
9. Remaining at university or being absent? 30 mins
10. How to maintain wellbeing 18 mins
Conclusion 3 mins

Attendance at the workshop is recorded to monitor adherence, including if participants attend only part of the workshop.

Gayed, A., Bryan, B. T., LaMontagne, A. D., Milner, A., Deady, M., Calvo, R. A., Mackinnon, A., Christensen, H., Mykletun, A., & Glozier, N. (2019). A cluster randomized controlled trial to evaluate HeadCoach: an online mental health training program for workplace managers. Journal of occupational and environmental medicine, 61(7), 545-551.
Milligan-Saville, J. S., Tan, L., Gayed, A., Barnes, C., Madan, I., Dobson, M., Bryant, R. A., Christensen, H., Mykletun, A., & Harvey, S. B. (2017). Workplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial. The Lancet Psychiatry, 4(11), 850-858
Intervention code [1] 329407 0
Behaviour
Comparator / control treatment
A waitlist-control group was used for comparison. The effectiveness of the training workshops was evaluated through a quasi-controlled trial. Three sessions were held in March 2023 and three in June 2023. Although participants were blinded to allocation, staff who chose to attend one of the earlier sessions were assigned to the intervention group, while those who opted to attend one of the later training sessions were allocated to the waitlist-control group.
Control group
Active

Outcomes
Primary outcome [1] 339268 0
Confidence in supporting student mental health
Timepoint [1] 339268 0
Baseline, 1-month post-intervention and 3-month follow-up (primary timepoint)
Secondary outcome [1] 439317 0
Mental health stigma
Timepoint [1] 439317 0
Baseline, 1-month post-intervention, and 3-month follow-up
Secondary outcome [2] 439318 0
Responsiveness to student mental health
Timepoint [2] 439318 0
Baseline, 1-month post-intervention, 3-months follow-up
Secondary outcome [3] 439322 0
Mental health knowledge
Timepoint [3] 439322 0
Baseline, 1-month post-intervention, and 3-month follow-up
Secondary outcome [4] 439323 0
Psychological distress
Timepoint [4] 439323 0
Baseline, 1-month post-intervention and 3-month follow-up

Eligibility
Key inclusion criteria
- 18 years or older
- Working within the participating faculty at the participating university
- Frequent contact with students
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Involved in any other mental health training programs ongoing at the Black Dog Institute (manager mental health training program for university staff or general staff mental health training program)

Study design
Purpose of the study
Educational / counselling / training
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be conducted using SPSSv27 statistical software. Baseline participant demographics between the intervention and control groups will be compared using chi squared and t tests. Logistic regression will be used to compare baseline scale total scores between groups to identify whether underlying differences in mental health knowledge, stigma, confidence or responsiveness influenced the choice of earlier or later workshops and subsequently intervention or control group allocation. Comparisons across outcomes over time between the intervention and control group will be analysed using an intent-to-treat framework utilising mixed-model repeated measure (MMRM) with an alpha of 0.05. Contrast estimates across each outcome for the intervention group compared to the control group will be analysed at post-intervention and 3-month follow-up from baseline.

Based on previous research into mental health training programs (Gayed, Bryan, et al., 2018), in order to detect a moderate effect size of 0.54 with 80% power using an alpha of 0.05, it was calculated that 126 participants were required. Anticipating a 20% dropout, we aim to recruit 150 participants.

Gayed, A., Bryan, B. T., Petrie, K., Deady, M., Milner, A., LaMontagne, A. D., Calvo, R. A., Mackinnon, A., Christensen, H., & Mykletun, A. (2018). A protocol for the HeadCoach trial: the development and evaluation of an online mental health training program for workplace managers. BMC psychiatry, 18, 1-9.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/03/2022
Date of last participant enrolment
Anticipated
Actual
30/03/2022
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
150
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317313 0
Government body
Name [1] 317313 0
NHMRC Investigator Grant
Country [1] 317313 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Country
Australia
Secondary sponsor category [1] 319592 0
None
Name [1] 319592 0
Address [1] 319592 0
Country [1] 319592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316043 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 316043 0
Ethics committee country [1] 316043 0
Australia
Date submitted for ethics approval [1] 316043 0
28/07/2022
Approval date [1] 316043 0
01/08/2022
Ethics approval number [1] 316043 0
HC220374

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

Contacts
Principal investigator
Name 136598 0
Dr Aimee Gayed
Address 136598 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136598 0
Australia
Phone 136598 0
+610290659043
Fax 136598 0
Email 136598 0
a.gayed@unsw.edu.au
Contact person for public queries
Name 136599 0
Aimee Gayed
Address 136599 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136599 0
Australia
Phone 136599 0
+610290659043
Fax 136599 0
Email 136599 0
a.gayed@unsw.edu.au
Contact person for scientific queries
Name 136600 0
Aimee Gayed
Address 136600 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136600 0
Australia
Phone 136600 0
+610290659043
Fax 136600 0
Email 136600 0
a.gayed@unsw.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24153Ethical approval    388385-(Uploaded-03-09-2024-10-20-52)-UNSW Ethics Approval_01082022.Pdf



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.