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Trial registered on ANZCTR


Registration number
ACTRN12624001110572
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
16/09/2024
Date last updated
16/09/2024
Date data sharing statement initially provided
16/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The development and pilot evaluation of an online mental health training program for managers in the aged care sector
Scientific title
The development and pilot evaluation of the impact of an online mental health training program on manager confidence, knowledge, stigma and behaviour in supporting employee mental health in the aged care sector
Secondary ID [1] 312748 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Confidence in supporting employee mental health 334783 0
Mental health knowledge 334784 0
Mental health stigma 334787 0
Behaviour towards employee mental health 335133 0
Condition category
Condition code
Mental Health 331345 331345 0 0
Depression
Mental Health 331346 331346 0 0
Anxiety
Mental Health 331347 331347 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A previously evaluated skills-based manager mental health training program (ACTRN12619001496101) will be adapted, in partnership with advisors from the aged care sector to ensure the program addresses the unique needs of this cohort of workers. The program will consist of three modules covering the following content:

1. An introduction to mental disorders commonly seen in the workplace
- How to recognise mental illness
- Your responsibilities as a manager
2. How to respond to workers who are symptomatic or unwell due to mental health reasons (responsive strategies)
- Identifying people at risk
- Providing support
- Talking to employees about mental health
- Encouraging someone to get help
- Modifying work to help recovery
- Helping employees return to work
3. How to minimise work-related mental health risk factors for staff (preventive strategies).
- How to be a responsible manager
- Creating a collaborative workplace
- Managing your team
- Managing difficult situations

Each training module comprises of text, activities, short videos and practice exercises to complete as part of the training. It is expected the entire program will take approximately 2 hours. The program has been designed for participants to complete at their own pace, at any time within the 6-month data collection period. The intervention will be delivered through a mobile responsive website and participants can complete the intervention on a desktop, laptop, tablet or smart phone.

Adherence to the online training program will be monitored through the online training platform. Reminder emails will be sent to participants who have not completed the program. Data will be available through the research platform on what percentage of the training program has been completed.
Intervention code [1] 329280 0
Behaviour
Comparator / control treatment
No control group in this pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339111 0
Manager confidence in effectively responding to employees experiencing mental health issues and in implementing techniques to create a mentally healthy work environment.
Timepoint [1] 339111 0
Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
Primary outcome [2] 339112 0
User experience of training program
Timepoint [2] 339112 0
Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
Secondary outcome [1] 438605 0
Managers' knowledge about common mental health conditions within the workplace.
Timepoint [1] 438605 0
Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
Secondary outcome [2] 438606 0
Managers' attitudes towards mental health in the workplace
Timepoint [2] 438606 0
Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
Secondary outcome [3] 438607 0
Managerial stigma towards employees experiencing mental health issues
Timepoint [3] 438607 0
Baseline and post-intervention (available to complete any time up to 1-month post-intervention)
Secondary outcome [4] 438608 0
Manager behaviour (both responsive behaviour to employees experiencing mental illness and preventative behaviour to prevent and reduce stress at work)
Timepoint [4] 438608 0
Baseline and post-intervention (available to complete any time up to 1-month post-intervention)

Eligibility
Key inclusion criteria
- Working in the aged care sector
- Supervising at least one employee in the aged care sector
- 18 years or above
- Residing and working in Australia
Minimum age
18 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
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/06/2024
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
200
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317179 0
Other
Name [1] 317179 0
Philanthropic funding from John and Anna Belfer (Belanna Pty Ltd)
Country [1] 317179 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Country
Australia
Secondary sponsor category [1] 319443 0
None
Name [1] 319443 0
Address [1] 319443 0
Country [1] 319443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315923 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 315923 0
https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
Ethics committee country [1] 315923 0
Australia
Date submitted for ethics approval [1] 315923 0
22/11/2023
Approval date [1] 315923 0
01/12/2023
Ethics approval number [1] 315923 0
iRECS4812

Summary
Brief summary
This research aims to evaluate the feasibility, acceptability and preliminary efficacy of a mental health training program for managers in the aged care industry. This skills-based mental health training program has been shown to be effective in other occupational groups and has been tailored, alongside representatives from the aged care workforce, to suit the needs of those working in the aged care sector.

The efficacy of the program will be evaluated through a pre-post intervention pilot trial design which aims to address the following research questions:
1. Is the delivery and content an adapted version of a previously evaluated manager training program tailored to managers working in Aged Care meeting the needs for this group?
2. Does training managers through a tailored workplace mental health program increase a) their knowledge in how to best support the mental health needs of the staff they supervise, b) their confidence to support the mental health needs of the staff they supervise and c) their application of responsive and preventive strategies to minimise psychosocial hazards in the workplace for the staff they supervise?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136230 0
Dr Mark Deady
Address 136230 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136230 0
Australia
Phone 136230 0
+61 29065 9144
Fax 136230 0
Email 136230 0
[email protected]
Contact person for public queries
Name 136231 0
Dr Aimee Gayed
Address 136231 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136231 0
Australia
Phone 136231 0
+61290659043
Fax 136231 0
Email 136231 0
[email protected]
Contact person for scientific queries
Name 136232 0
Dr Aimee Gayed
Address 136232 0
Black Dog Institute, Hospital Road Randwick NSW 2031
Country 136232 0
Australia
Phone 136232 0
+61290659043
Fax 136232 0
Email 136232 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24109Ethical approval    388293-(Uploaded-19-08-2024-11-03-03)-231122 iRECS4812 More than low risk application - Approved.pdf



Results publications and other study-related documents

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