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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04982094




Registration number
NCT04982094
Ethics application status
Date submitted
21/06/2021
Date registered
29/07/2021

Titles & IDs
Public title
Counting On U: Towards Better Mental Health
Scientific title
Counting On U: Supporting SME Advisors and Owners Towards Better Mental Health
Secondary ID [1] 0 0
2020-399
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health Wellness 1 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Mental Health First Aid and Relationship Building Training
BEHAVIORAL - Mental Health First Aid

Experimental: Mental Health First Aid and Relationship Building Training (MHFA+RBT) - Mental Health First Aid training in conjunction with Relationship Building Training.

Active comparator: Mental Health First Aid (MHFA only) - Mental Health First Aid training alone.


BEHAVIORAL: Mental Health First Aid and Relationship Building Training
Relationship Building Training (RBT) is a 2 hour training session conducted live over zoom, that aims to equip business advisors the communications skills they need to enhance trustworthiness and quality of the relationship with their clients.

Mental Health First Aid (MHFA) is a certified training program. It requires 5-7 hours of online course work followed by 2 x 2.5 hour live zoom sessions, that aims to enhance mental health literacy and teach the skills needed to identify the signs of mental health conditions and to have a conversation with a person who may need professional help.

Two Booster sessions are delivered 1- and 3-months after the last MHFA session that aims to give participants the opportunity to consolidate their learning and share experiences applying the knowledge/skills gained.

Participants will also invite 2-3 of their small-business entrepreneur (SME) clients to join the study and complete 3 surveys to provide feedback on the success of the program.

BEHAVIORAL: Mental Health First Aid
Mental Health First Aid (MHFA) is a certified training program. It requires 5-7 hours of online course work followed by 2 x 2.5 hour live zoom sessions in addition to online reading, that aims to enhance mental health literacy and teach the skills needed to identify the signs of mental health conditions and to have a conversation with a person who may need professional help.

MHFA online training is conducted two-weeks before the two MHFA sessions (with a 1 day break in between each MHFA). Two Booster sessions are delivered 1- and 3-months after the last MHFA session. The Booster sessions aims to give participants the opportunity to consolidate their learning and share experiences applying the knowledge/skills gained.

Participants will also invite 2-3 of their small-business entrepreneur (SME) clients to join the study and complete 3 surveys to provide feedback on the success of the program.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the quality of the relationship between the small-medium business owner with the business advisor.
Timepoint [1] 0 0
SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training
Secondary outcome [1] 0 0
Process evaluation
Timepoint [1] 0 0
Baseline, mid-training, 5-months post training
Secondary outcome [2] 0 0
Change in psychological distress
Timepoint [2] 0 0
SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training
Secondary outcome [3] 0 0
Change in MHFA knowledge
Timepoint [3] 0 0
BAs: Baseline, 1 + 5 months post training
Secondary outcome [4] 0 0
Change in confidence to provide MHFA
Timepoint [4] 0 0
BAs: Baseline, 1 + 5 months post training
Secondary outcome [5] 0 0
Change in stigmatisation
Timepoint [5] 0 0
BAs: Baseline, 1 + 5 months post training
Secondary outcome [6] 0 0
Change in health seeking behaviour
Timepoint [6] 0 0
SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training
Secondary outcome [7] 0 0
Change in health, comfort, and happiness experienced by the individual (Quality of life).
Timepoint [7] 0 0
SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training
Secondary outcome [8] 0 0
Change in financial wellbeing of small-medium enterprise (SME) owners
Timepoint [8] 0 0
SMEs: Baseline, 5 and 11 month post-training.
Secondary outcome [9] 0 0
Change in the degree of trust the small-medium business owner has in their business advisor
Timepoint [9] 0 0
SMEs: Baseline, 5 + 11 months post training.
Secondary outcome [10] 0 0
Change in financial pressure
Timepoint [10] 0 0
SMEs: Baseline, 5 + 11 months post training.
Secondary outcome [11] 0 0
Autonomy
Timepoint [11] 0 0
BAs: Baseline + 5 months post training
Secondary outcome [12] 0 0
Emotional
Timepoint [12] 0 0
BAs: Baseline, + 5 months post training
Secondary outcome [13] 0 0
Workload
Timepoint [13] 0 0
BAs: Baseline + 5 months post training
Secondary outcome [14] 0 0
Confidence and resilience
Timepoint [14] 0 0
SMEs: Baseline, 5 + 11 months post training. BAs: 1 + 5 months post training
Secondary outcome [15] 0 0
Social support
Timepoint [15] 0 0
SMEs: Baseline, 5 + 11 months post training. BAs: Baseline + 5 months post training

Eligibility
Key inclusion criteria
* Any qualified business advisor from Australia or New Zealand who provides business advice to a small-medium enterprise client (SME). Business advice refers to the information, guidance and/or assistance provided by an external adviser that either directly or indirectly helps to prevent/reduce the financial pressures experienced by SME owner-clients.
* The SME client must be the owner-manager/operator with 1-199 employees, including the owner-manager themselves.
* The business advisor must be in contact with their SME client at least 3 times a year.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

* Any business advisor who has completed Mental Health First Aid within the last two years.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
1599
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Deakin University - Burwood
Recruitment postcode(s) [1] 0 0
3125 - Burwood

Funding & Sponsors
Primary sponsor type
Other
Name
Leanne Saxon
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institute of Public Accountants
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Beyond Blue
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
WorkSafe Victoria
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Mental Health First Aid Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Andew Noblet, PhD
Address 0 0
Deakin University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04982094