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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04982094
Other study ID # 2020-399
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date September 30, 2023

Study information

Verified date March 2024
Source Deakin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The widespread lockdown of broader society experienced around the world due to the COVID-190 pandemic is unprecedented. Businesses in a variety of sectors such as manufacturing, retail, and hospitality were closed due to lockdown rules, a decrease in demand, health concerns or other factors. Many of the closures are permanent because of the inability of business owners to pay ongoing expenses and market uncertainty. Small to medium enterprises (SMEs) account for 99% of all businesses in Australia and at least 95% of enterprises in all OECD countries. SMEs provide an important contribution to Australia's growth in employment, with small businesses (including micro businesses) employing approximately 4.72 million people and accounting for 41 per cent of total employment. To help citizens survive the pandemic, the Australian government provided financial support to employees via Job Keeper and cash flow boosts to eligible businesses. Nevertheless, some SME owners reported losing up to 90% of their income and continue to face ongoing challenges, including market uncertainty, loss of international skilled workers, lending restrictions, extensive legislative reform. At the same time that they're dealing with an increasingly difficult external environment, SME owners also have to content with running a business including monitoring cash flow, managing staff, and ensuring the smooth administration of the business. Of the challenges faced by SME owners, financial pressure represents a major source of psychological distress and is likely to explain why SME owners generally experience higher levels of stress and mental health disorders compared with the broader population. In Australia, 1 in 3 SMEs rated their mental health as poor to fair during the pandemic. Identifying the symptoms of depression early and encouraging help seeking are therefore critical and cost-effective methods for protecting and promoting wellbeing. Mental health literacy programs have emerged as a key strategy for the early identification of diagnosable mental health problems. The strategy has proved to be popular in the frontline human service sectors (e.g., health care, social work) where MHFA can be used to help colleagues and members of the public who may be experiencing the signs of depression, anxiety and other mental health conditions (MHC's). However, little is known about the effectiveness of mental health literacy programs where SME owners are concerned. Reaching vast numbers of owner-managers in a systematic way is thought to be particularly difficult, partly because of the absence of viable intermediaries that have ongoing contact with this group, but also because of the typical characteristics of the SME owner's role (e.g., long working hours, burden of responsibility, isolation, obligation to work when sick), coupled with their lack of financial resources. One sector that has the potential to act as an intermediary between small business and mental health services are business advisors, who include accountants, financial planners and financial counsellors. Business advisors are an important source of support for SME owners as their expertise is sought on a regular basis and clients can develop trusting, long-term relationships with their accountant. Previous work in this sector by Bond and colleagues has shown that MHFA training is an effective way of improving financial counsellors' ability to recognise mental health problems among clients and to provide appropriate support for help-seeking. Despite the importance of mental health prevention programs like MHFA, these strategies are designed to reduce the impact of mental health conditions (i.e. secondary and tertiary prevention) rather than prevent them from occurring in the first instance (i.e., primary prevention). Longitudinal evidence causally implicates adverse psychosocial working conditions (e.g., excessive workloads, inadequate support) in the development of MHCs, such as depression. Thus, if business advisors can work to alleviate these stressors, they may also help prevent the onset of MHCs. Therefore, the aim of the current project is to assess a new approach to undertaking MHFA training by incorporating a client-centred, Relationship Building Training (RBT) program that is designed to help business advisors better understand the business and personal needs of SME owners. If they better understand their needs, the business advisor can provide higher quality advice and in turn, reduce the financial stress of the SME owner. For any of this to happen, there needs to be a degree of trust generated between the business advisor and their SME client. According to Manister's trust equation, trustworthiness can be increased by improving how credible, reliable, and intimate you are and by decreasing your self-orientation. Thus, the RBT aims to equip the business advisor with the skills they need to enhance their intimacy and decrease their self-orientation. It is proposed, that if the business advisor builds a more trusting relationship with their clients that: i) it will reduce information asymmetry between the business advisor and client, enabling a better understanding of the SME's needs that leads to more personalised, tailed advice. In turn, this will alleviate the SME's financial stress and help prevent the onset of MHCs; and ii) it will allow the SME to feel more comfortable disclosing any financial concerns and/or mental health problems and when combined with the MHFA, the business advisor will better recognise the signs of MHCs and encourage them to seek help where appropriate. Thus, this study represents a crucial next step in protecting the mental health of SME owners by assessing the incremental effectiveness of combining a primary prevention strategy (RBT) with the tertiary and secondary-level prevention approach of MHFA on the prevention of MHC's. It will be the first to assess the effectiveness of the approach through a randomised control trial (RCT) using a national sample of practising business advisors and their SME owner clients. Combined with the effectiveness trial, a process evaluation will be employed to identify the programs strengths and areas for improvement and to inform the expansion of this program to other sectors.


Recruitment information / eligibility

Status Completed
Enrollment 1599
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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. Exclusion Criteria - Any business advisor who has completed Mental Health First Aid within the last two years.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Australia Deakin University Burwood Victoria

Sponsors (5)

Lead Sponsor Collaborator
Leanne Saxon Beyond Blue, Institute of Public Accountants, Mental Health First Aid Australia, WorkSafe Victoria

Country where clinical trial is conducted

Australia, 

References & Publications (42)

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Karasek RA. Job demands, job decision latitude, and mental strain: Implications for job redesign. Administrative Science Quarterly. 1979: 24: 285-308.

LaMontagne AD, Martin A, Page KM, Reavley NJ, Noblet AJ, Milner AJ, Keegel T, Smith PM. Workplace mental health: developing an integrated intervention approach. BMC Psychiatry. 2014 May 9;14:131. doi: 10.1186/1471-244X-14-131. — View Citation

LaMontagne AD, Milner AJ, Allisey AF, Page KM, Reavley NJ, Martin A, Tchernitskaia I, Noblet AJ, Purnell LJ, Witt K, Keegel TG, Smith PM. An integrated workplace mental health intervention in a policing context: Protocol for a cluster randomised control trial. BMC Psychiatry. 2016 Feb 27;16:49. doi: 10.1186/s12888-016-0741-9. — View Citation

Landells EM, Albrecht SL. Perceived Organizational Politics, Engagement, and Stress: The Mediating Influence of Meaningful Work. Front Psychol. 2019 Jul 10;10:1612. doi: 10.3389/fpsyg.2019.01612. eCollection 2019. — View Citation

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Morgan AJ, Ross A, Reavley NJ. Systematic review and meta-analysis of Mental Health First Aid training: Effects on knowledge, stigma, and helping behaviour. PLoS One. 2018 May 31;13(5):e0197102. doi: 10.1371/journal.pone.0197102. eCollection 2018. — View Citation

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Ramsden M, Bennett R. The benefits of external support to SMEs: "Hard" versus "soft" outcomes and satisfaction levels. Journal of Small Business and Enterprise Development. 2005;12(2):227-43.

Reavley NJ, Jorm AF. Stigmatizing attitudes towards people with mental disorders: findings from an Australian National Survey of Mental Health Literacy and Stigma. Aust N Z J Psychiatry. 2011 Dec;45(12):1086-93. doi: 10.3109/00048674.2011.621061. Epub 2011 Oct 24. — View Citation

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Tetrick LE, Slack KJ, Da Silva N, Sinclair RR. A comparison of the stress-strain process for business owners and nonowners: differences in job demands, emotional exhaustion, satisfaction, and social support. J Occup Health Psychol. 2000 Oct;5(4):464-76. doi: 10.1037//1076-8998.5.4.464. — View Citation

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Yap MB, Reavley NJ, Jorm AF. Is the use of accurate psychiatric labels associated with intentions and beliefs about responses to mental illness in a friend? Findings from two national surveys of Australian youth. Epidemiol Psychiatr Sci. 2015 Feb;24(1):54-68. doi: 10.1017/S2045796013000607. Epub 2013 Nov 7. — View Citation

* Note: There are 42 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Process evaluation The RE-AIM framework will be used to guide our evaluation of the intervention (Counting on U) (Glasgow 1999). RE-AIM stands for Reach, Effectiveness, Adoption, Implementation, and Maintenance. Field notes will be recorded, and structured interviews will be conducted with various stakeholders, including the business advisors, SME owners, trainers, and accounting/bookkeeper member bodies who will assist with the recruitment of business advisors. Process evaluation of Counting on U will help inform: 1) the future expansion and implementation of this program to various populations and 2) reveal both strengths and areas for improvement of the program strategies. Baseline, mid-training, 5-months post training
Secondary Change in psychological distress Psychological Distress of the SME owners and business advisors will be measured using the Kessler 6 (K6) (Kessler et al 2002). This non-specific scale screens individuals for severe mental illness as defined as a K6 score =13. The K6 asks respondents, in the past four weeks how often did they feel the following: nervous, hopeless, restless or fidgety, worthless, depressed and felt that everything was an effort. For each question, a value of zero to four is assigned (0 none of the time, 4 all of the time), and a total score summed out of 24. The scale has demonstrated excellent internal consistency and reliability (Cronbach's alpha = 0.89) (Kessler et al 2002). SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training
Secondary Change in MHFA knowledge Knowledge about mental health problems will be assessed using 18 questions adapted by Jorm et al (2010) that reviews information taught on day 1 and 2 of the Mental Health First Aid course. Questions consist of statements rated as Agree, Disagree or Unsure. The total score will be the number of questions answered correctly. An examples question is: "Half of all people who experience a mental illness have their first episode by age 18". BAs: Baseline, 1 + 5 months post training
Secondary Change in confidence to provide MHFA Provision of Mental Health First Aid questions will include whether the business advisor had talked to a SME owner about their mental health problems over the past month using a 4-point Likert scale (1 never, 4 many times) (Jorm et al 2010). If they have talked with a SME owner client, they will be asked to indicate how many out of 12 actions they had taken. A score of 1 will be allocated to any action they have taken A Few or Many Times and summing these scores. BAs: Baseline, 1 + 5 months post training
Secondary Change in stigmatisation Stigmatising attitude of the business advisors will be measured using six statements that queries their opinion of a person described in a vignette (personal stigma) (Reavley 2011). The modified vignette (Yap et al 2015) portrays a 35-year-old business owner who is showing signs of depression. An example of a personal stigma item is: "A problem like John's is a sign of personal weakness". Each item is scored on 5-point Likert scale (1 strongly agree, 5 strongly disagree) and the total score will be the number of items answered Agree or Strongly Agree. BAs: Baseline, 1 + 5 months post training
Secondary Change in health seeking behaviour Actual Health Seeking Behaviour questions will assess the SME owners and business advisor's behaviour of actively seeking assistance for mental health problems (Rickwood et al. 2005). The scale covers the informal, formal as well as physical and emotional aspect of help-seeking behaviour. The participant is asked to select from a list of people they have gone to for advice or help in the past two weeks. SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training
Secondary Change in health, comfort, and happiness experienced by the individual (Quality of life). Quality of Life questions will measure the general health of the business advisors and SME owners. The Short Form-12 questionnaire (SF-12) produces two summary scores - a mental component score (MCS-12) and a physical component score (PCS-12). This questionnaire has a test re-test reliability of 0.76 to 0.89 for the mental (MCS-12) and physical (PCS-12) health components (Ware 1996). Both components can discriminate among groups known to differ in their physical and mental conditions, yielding relative validities of 0.63 to 1.07 (Ware 1996). The answers are weighted, and the results are presented in reference to the United States population profile at the time of the original publication in 1994. A higher score for MCS and PCS indicates a better health state. SMEs: Baseline, 5 + 11 months post training. BAs: Baseline, 1 + 5 months post training
Secondary Change in financial wellbeing of small-medium enterprise (SME) owners Financial Wellbeing Questionnaire (Prawitz 2006) consists of 8 items designed to gather information on how positively the SME owners view their financial situation. Each answer is scored from 1 to 10, and the total is summed and divided by 8. A higher score indicates no financial distress/ high financial well-being. The internal reliability of the scale is robust with a Cronbach's alpha of 0.956 indicating that the items contributing to the measurement of financial well-being, consistently yielded similar results. Factor loadings ranged from 0.83 to 0.93, indicating the measurement of only one latent construct. SMEs: Baseline, 5 and 11 month post-training.
Secondary Change in the degree of trust the small-medium business owner has in their business advisor Trust in Business Advisor Questionnaire measures the three elements of trust defined by Cherry et al. (2018): confidence, acting proactively and not exploiting vulnerabilities. In addition, the SME owner's confidence in the services (i.e., beyond compliance services) offered by the business advisor will be measured. Eleven questions will assess trust on a 5-point Likert scale (1 strongly disagree, 5 strongly agree) with a higher total score indicating a more trusting relationship. Factor loading for the items range from 0.43 to 0.95 and shows good reliability, with a Cronbach's alpha of 0.931 to 0.937. SMEs: Baseline, 5 + 11 months post training.
Secondary Change in financial pressure Perceived Financial Wellbeing questions developed by Netemeyer et al 2018, asks the SME owners to consider how much they agree with 5 statements such as "I am behind with my finances". Their answers will be scored on a 5-point Likert scale (1 strongly agree, 5 strongly disagree) and a lower total mean score will indicate a more positive outlook. Perceived financial wellbeing is a strong predictor of overall well-being and has a Cronbach's alpha of 0.86 to 0.94 (Netemeyer et al. 2018). SMEs: Baseline, 5 + 11 months post training.
Secondary Autonomy Autonomy will be measured using a 3-item scale that asks how much control the business advisor feels they have over their work and scored on a 5-point Likert scale (1 strongly disagree, 5 strongly agree) (Bakker et al, 2004, Karasek 1985). A mean score will be generated and a higher score indicating greater autonomy. The Cronbach's alpha is 0.68. BAs: Baseline + 5 months post training
Secondary Emotional Emotional Demands on the business advisors will be measured using the second version of the Copenhagen Psychosocial Questionnaire (Pejtersen et al, 2010). There are four items exploring how emotionally demanding they find their work, two items are measured on one 5-point Likert scale (1 never, hardly, 5 always) and two on a different 5-point Likert scale (1 to a very small extent, 5 to a large extent). The Cronbach's alpha is 0.87. BAs: Baseline, + 5 months post training
Secondary Workload Workload of the business advisors will be measuring using 3 items on a 5-point scale (1, not at all, 5 to a great extent) (Albrecht 2015, Karasek 1979). They will be asked their thoughts on statements such as "to what extent is there not enough time for you to do your job?" A mean score will be generated, and a higher score indicates a more demanding workload. The Cronbach's alpha is: 0.85 to 0.88. BAs: Baseline + 5 months post training
Secondary Confidence and resilience Psychological Capital Short Form (PCQ-12) questionnaire measures wellbeing as a function of four emotions, two of which will be measured in the SME owners and business advisors: resilience and self-efficacy (Kamei et al 2018). Participants will respond to six statements on a 6-point Likert scale (1 strongly disagree, 6 strongly agree). PCQ-12 is designed for working adults and both resilience and self-efficacy statements are significantly correlated with measures of satisfaction with life, happiness and perceived stress (-0.36 to 0.50). The factor loadings of the questions range from 0.30 to 0.87. SMEs: Baseline, 5 + 11 months post training. BAs: 1 + 5 months post training
Secondary Social support Social Support questions assess the extent of emotional social support the participant receives from clients, family and friends, or colleagues and peers (Totterdal et al. 2006). The business advisors and SME owners will be asked two questions about each source: how easy is to talk to the people concerned and are the people concerned willing to listen to your problems. Responses are recorded on a 5-point Likert scale (1 not at all, 5 a great deal). The higher the score, the higher the social support. The Cronbach's alpha is 0.81. SMEs: Baseline, 5 + 11 months post training. BAs: Baseline + 5 months post training
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