NCT04982094

Brief Summary

The financial state of a business and the mental health of the business owner are closely related. Thus, the devastating impact of COVID-19 on businesses means small-medium enterprises (SMEs) owners are particularly vulnerable to experiencing depression, anxiety and other mental health conditions (MHC). However, there is a tendency for SME owners to seek help about their financial concerns, rather than their mental wellbeing. For this reason, trusted business advisors (accountants, bookkeepers, coaches) who engage with their SME clients on a regular basis, are well-placed to provide advice about both the financial and mental health concerns of their SME clients. To provide business advisors with the skills they need to have a conversation with their clients about their mental wellbeing and to encourage help-seeking where appropriate, mental health first aid (MHFA) training will be offered. And to help the business advisor forge a more trusting relationship with their client and provide higher quality advice that may alleviate their financial stresses, Relationship Building Training (RBT) will also be provided. Thus, the aim of this randomised control trial is to assess the additional benefit of combining RBT with MHFA compared with MHFA alone on the financial wellbeing of SME clients and the quality of their relationship with their business advisor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,599

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

June 21, 2021

Last Update Submit

March 27, 2024

Conditions

Keywords

PreventionMental HealthAccountantsSmall business owner

Outcome Measures

Primary Outcomes (1)

  • Change in the quality of the relationship between the small-medium business owner with the business advisor.

    Quality of the Relationship Questionnaire aims to measure the SME owner's satisfaction with the level of attention they are receiving from the business advisor, and the business advisor's belief about how much attention they are providing. For the business advisors, 10 items will be used, four are from the Relationship Flourishing Scale (Fowers et al. 2016) that has a Cronbach's alpha of 0.93, and six are from a newly developed tool by principal investigators (AN, GT) with factor loadings of 0.81 to 0.87. The SME's will answer the latter six items. All items are on a 7-point Likert scale (1 strongly disagree, 7 strongly agree) with a higher total score indicating a stronger relationship.

    SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training

Secondary Outcomes (15)

  • Process evaluation

    Baseline, mid-training, 5-months post training

  • Change in psychological distress

    SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training

  • Change in MHFA knowledge

    BAs: Baseline, 1 + 5 months post training

  • Change in confidence to provide MHFA

    BAs: Baseline, 1 + 5 months post training

  • Change in stigmatisation

    BAs: Baseline, 1 + 5 months post training

  • +10 more secondary outcomes

Study Arms (2)

Mental Health First Aid and Relationship Building Training (MHFA+RBT)

EXPERIMENTAL

Mental Health First Aid training in conjunction with Relationship Building Training.

Behavioral: Mental Health First Aid and Relationship Building Training

Mental Health First Aid (MHFA only)

ACTIVE COMPARATOR

Mental Health First Aid training alone.

Behavioral: Mental Health First Aid

Interventions

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.

Also known as: MHFA and RBT
Mental Health First Aid and Relationship Building Training (MHFA+RBT)

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.

Also known as: MHFA alone
Mental Health First Aid (MHFA only)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deakin University

Burwood, Victoria, 3125, Australia

Location

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MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Andew Noblet, PhD

    Deakin University

    PRINCIPAL INVESTIGATOR
  • George Tanewski, PhD

    Deakin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Business advisor participants will be randomised to the treatment or control group using block randomisation. This process will be conducted by an external organisation who the participants are members of, so the trial investigators are blind to what study arm the participants are randomised to. The external organisation will provide potential participants with a computer generated unique ID, then order the IDs from highest to lowest, divide the list in half and allocate a block to the treatment or control arm. Allocation concealment will be achieved because the external organisation will not be able to predict the unique ID allocated to each participant before they are randomised to a group. The outcome assessor will be blinded to the participants study arm for the preliminary analysis. There are no subjective measures in this study. The participants will be blinded to their study group before they agree to participate to avoid self-selection bias.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 29, 2021

Study Start

March 1, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations