Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001156774
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
16/10/2013
Date last updated
19/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of mental health training for managers
Scientific title
The effectiveness of mental health training for managers working in Fire and Rescue NSW on knowledge, attitudes, confidence and behaviour.
Secondary ID [1] 281980 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
RESPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The proposed study seeks to test the effectiveness of a combined program of mental health literacy and sickness absence management for Duty Commanders within Fire and Rescue NSW. Specifically, the study will examine the effectiveness of the combined program in increasing mental health literacy, reducing stigma around mental illness, increasing manager knowledge of their role in sickness absence management as well as increasing confidence and encouraging early communication with employees on sickness absence leave. Importantly, we will also investigate the potential impact of the training in reducing overall sickness absence rates within Fire and Rescue NSW. 288409 0
Condition category
Condition code
Mental Health 288760 288760 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new type of manager training, which combines mental health literacy with sickness absence management is soon to be rolled out across Fire and Rescue NSW. This single session training will be delivered by the Black Dog Institute to groups of 8 to 12 managers over a 4 hour period. The training is designed to be very interactive and to focus on the enhancing of confidence and skills rather than didactic lectures. Following the face to face training, there will also be two follow up phone contacts to provide additional support and evaluation. The first of these phone calls (which will be made by an EAP Manager Support Service) will be between 3 and 4 weeks after the training, while the second will occur between 6 to 8 weeks after the training.
Intervention code [1] 286552 0
Behaviour
Intervention code [2] 287808 0
Other interventions
Comparator / control treatment
All Duty Commanders within Fire and Rescue NSW will be asked to attend this training. It is planned that the new training will be rolled out across Sydney Metropolitan NSW Fire and Rescue over a period of six months. In order to facilitate evaluation of the program, Fire NSW have agreed to randomly allocate the order in which Duty Commanders receive this training, with half receiving the training in the first wave of teaching and the half receiving the training in a second wave of teaching which will occur six months later (wait-list control group). This will allow those receiving the training in the second wave to act as a comparison group over a six month follow up period following the first wave of teaching.
Control group
Active

Outcomes
Primary outcome [1] 288899 0
The primary outcome of interest in this study is the rate of sickness absence. This is calculated as the total number of hours of sickness absence divided by the sum of the total number of hours of sickness absence and hours of attendance.
Timepoint [1] 288899 0
Baseline and 6 months after training intervention
Secondary outcome [1] 301265 0
Mental health literacy questionnaire developed by the researchers
Timepoint [1] 301265 0
Baseline, immediately after training, and 6 months after training intervention
Secondary outcome [2] 301266 0
Attitudes towards mental illness (Stigma) using modified versions of measures of personal stigma towards depression, anxiety and PTSD (Griffiths, Christensen, Jorm, Evans and Groves, 2004; Griffiths et al. 2011, Greenberg, Gould, Langston and Brayne, 2009)
Timepoint [2] 301266 0
Baseline, immediately after training, and 6 months after training intervention.
Secondary outcome [3] 301267 0
Confidence in communicating with employees who might have mental illness. The measure was developed by the researchers and will be assessed using a questionnaire.
Timepoint [3] 301267 0
Baseline, immediately after training, and 6 months after training intervention.
Secondary outcome [4] 301268 0
Knowledge on manager's role in managing employees on sickness absence leave. The measure was developed by the researchers and will be assessed using a questionnaire.
Timepoint [4] 301268 0
Baseline, immediately after training, and 6 months after training intervention.
Secondary outcome [5] 301269 0
Early communication with employees on sickness absence leave possibly due to mental illness. The measure was developed by the researchers and will be assessed using a questionnaire.
Timepoint [5] 301269 0
Baseline, immediately after training, and 6 months after training intervention.

Eligibility
Key inclusion criteria
Duty Commander (or equivalent or higher level of seniority) in Fire and Rescue NSW, Metropolitan region
Good English comprehension
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to provide informed consent

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)
Participants will be recruited as part of the ongoing standard training for Duty Commanders within Fire and Rescue NSW. It is planned that the new training will be rolled out to all Duty Commanders within Fire and Rescue NSW over a period of six months. Allocation will be concealed so the researchers would be unable to which group the subject would be allocated during the decision to determine eligibility.

In order to facilitate evaluation of the program, Fire NSW have agreed to randomly allocate the order in which Duty Commanders receive this training, with half receiving the training in the first wave of teaching and the half receiving the training in a second wave of teaching after a 6 month delay. An email/memo from Fire NSW to all Duty Commanders will be sent notifying them of the upcoming training and the associated research study. Following this memo, all Duty Commanders will then be approached and provided with the Participant Information Sheet and Consent Form. As outlined in the information sheet, it will be made clear to all potential participants that participation in the research study is entirely voluntary and that they can still receive the training without participating in the evaluation. Duty Commanders who are to receive the new training during the second wave of teaching (six months after the first wave) will be sent a letter in November informing them that will be receiving their training at a later date and introducing the associated research project. This letter will include the Participant Information Sheet and Consent Form . As outlined above, they will have previously received a memo from NSW Fire and Rescue informing them of this research study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be given a participant number. Randomisation computer software will be used to provide a random assignment of participants to each group. Block randomisation according to shift patterns will be used to aid the logistics of providing the training
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
The statistical analysis for this project will be conducted using STATA statistical software. The primary outcome will be comparison of the mean number of hours sickness absence between the intervention and control groups, which will be tested for using multivariate linear regression with appropriate controls for clustered data. Currently, the average number of hours of sickness absence taken by Fire and Rescue NSW staff is 118 hours per year. An average reduction of 10 hours per annum in the intervention group would be considered a meaningful and important effect. As the intervention is being delivered at the level of duty commanders, the potential clustering of sickness absence within staff groups needs to be accounted for in the power calculations. Based on an average of 25 staff members per group, a standard deviation in the number of hours of sickness absence of 60 and an intragroup correlation of 0.05, a total of 98 duty commanders would need to be recruited to this study to achieve 0.8 power with an alpha of 0.05 (two sided). A total of 130 duty commanders within the metropolitan NSW Fire and Rescue service will be required to undertake this new training. Assuming at least 75% agree to participate with the training evaluation, adequate power should be achieved.

Differences in other outcome measures, such as levels of mental health literacy, stigma, awareness of a manager’s role, confidence in communicating with ill staff and self-reported levels of communication will also be tested.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/11/2013
Actual
18/02/2014
Date of last participant enrolment
Anticipated
29/11/2013
Actual
29/04/2014
Date of last data collection
Anticipated
29/05/2014
Actual
29/10/2014
Sample size
Target
130
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6356 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 286758 0
Commercial sector/Industry
Name [1] 286758 0
Employers Mutual
Country [1] 286758 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychiatry
Black Dog Institute
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 285539 0
Charities/Societies/Foundations
Name [1] 285539 0
The Black Dog Institute
Address [1] 285539 0
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country [1] 285539 0
Australia
Other collaborator category [1] 277292 0
Government body
Name [1] 277292 0
Fire and Rescue New South Wales
Health and Safety
Address [1] 277292 0
Health and Safety
Fire and Rescue New South Wales
Level 8, 227 Elizabeth Street,
Sydney, NSW 2000
Country [1] 277292 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288828 0
UNSW HUMAN RESEARCH ETHICS COMMITTEE (HREC)
Ethics committee address [1] 288828 0
Ethics committee country [1] 288828 0
Australia
Date submitted for ethics approval [1] 288828 0
02/10/2012
Approval date [1] 288828 0
29/11/2012
Ethics approval number [1] 288828 0
HC12562

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

Contacts
Principal investigator
Name 37958 0
Dr Samuel Harvey
Address 37958 0
School of Psychiatry, UNSW
G06, Black Dog Institute
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country 37958 0
Australia
Phone 37958 0
+612 9382 8356
Fax 37958 0
+612 9382 8151
Email 37958 0
[email protected]
Contact person for public queries
Name 37959 0
Samuel Harvey
Address 37959 0
School of Psychiatry, UNSW
G06, Black Dog Institute
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country 37959 0
Australia
Phone 37959 0
+612 9382 8356
Fax 37959 0
+612 9382 8151
Email 37959 0
[email protected]
Contact person for scientific queries
Name 37960 0
Samuel Harvey
Address 37960 0
School of Psychiatry, UNSW
G06, Black Dog Institute
Hospital Road, Prince of Wales Hospital
Randwick NSW 2031
Country 37960 0
Australia
Phone 37960 0
+612 9382 8356
Fax 37960 0
+612 9382 8151
Email 37960 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
SourceTitleYear of PublicationDOI
EmbaseWorkplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial.2017https://dx.doi.org/10.1016/S2215-0366%2817%2930372-3
N.B. These documents automatically identified may not have been verified by the study sponsor.