Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000786796
Ethics application status
Approved
Date submitted
23/05/2022
Date registered
2/06/2022
Date last updated
2/06/2022
Date data sharing statement initially provided
2/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
BETTER MAN: A healthy relationship tool to encourage help seeking for men who use violence in their intimate relationships
Scientific title
A randomised controlled trial of the impact of a healthy relationship tool on help-seeking behaviour of men who use intimate partner violence (BETTER MAN)
Secondary ID [1] 307066 0
University of Melbourne CT ID: 23836
Universal Trial Number (UTN)
U1111-1278-2546
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Domestic violence 326288 0
Condition category
Condition code
Public Health 323600 323600 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BETTER MAN is a healthy relationship website for early intervention that offers a private, accessible and non-judgemental resource for men who use intimate partner violence.
The website uses interactive quizzes with feedback messaging to participants and short videos and animations. There is no interaction with the research team. Motivational interviewing techniques are used across the three sequential modules (Better Communication, Better Values, Better Relationships) that compose BETTER MAN. The exercises in each module aim to encourage awareness and self-reflection, reduce stigma to seek help, and improve communication skills. The final module (Take Action) provides men with an action plan with specific strategies to seek help for their behaviour in relationships, any mental health, alcohol, drug and gambling issues and if they have children, addressing parenting issues.

All modules have online messaging tailored to user input and below we describe each module and provide an example of feedback.

The BETTER COMMUNICATION module looks at how a man’s communication style may differ with a partner compared to others, and promotes positive communication (listening, staying calm), use of a grounding breathing exercise and recognising signals of potentially abusive behaviour. At the end of the module, participants are invited to set communication goals and reflect on how they would like to respond next time they have an argument with their partner or ex-partner.

The BETTER VALUES module explores how men’s behaviour in relationships aligns with his self-identified values using hypothetical scenarios to highlight discrepancy between values and behaviour. In the core activity of this module, participants choose the values that are most important to them in their intimate relationships, answer how they would likely respond to certain relationship issues, rate how true they think their responses are to their values, and receive feedback (e.g., "You have indicated that your responses and values are somewhat true to each other. It's great that your values and behaviours match sometimes, but there might be other things in your life that are distracting you from being true to what is truly important to you. Taking time out to consider the kind of person and partner you want to be can help to bring your values and behaviours closer together").

The BETTER RELATIONSHIPS module encourages a man to reflect on the health of his relationship, his behaviours (physical, emotional, sexual abuse), and weigh up pros/cons of his relationship, including reflecting on his relationship with his children. In one of the activities, participants are invite to reflect on their behaviours in their intimate relationships. They first selected within a list of risk behaviours (e.g., "called my partner names or told them they're crazy", "used physical force against my partner and/or children?") those that they might have done, and then receive feedback (e.g., "Remember: We are talking about your behaviours, not you as a person. Behaviours can be changed! Better Man will help you to see that it's never too late to change and that it is easier with the right help. High risk: The answers you have given suggest your behaviours are putting your partner or family in danger. There is help available to reduce this danger. Men's Referral Service are available 24/7 and are trained to help support safety in situations such as yours.")

A final TAKE BETTER ACTION section reinforces help seeking, and provides resources for related areas (parenting, alcohol/drug use, mental health). The modules take 30 minutes and men can go back to the website any time over the six month period. We will access web-portal analytics to understand adherence to the intervention module.
Intervention code [1] 323581 0
Behaviour
Comparator / control treatment
Men in the comparison arm will be randomised to an alternate website, specially built for the study representing the usual available standard resources for men seeking help online for relationship issues. This comparison website has been adapted from HealthDirect (www.healthdirect.gov.au), which is a government-funded service providing free quality, approved health information and advice. The comparator website covers information and advice for people to build and maintain healthy relationships with their partners and family members. Men will spend time on this website at their own discretion. The website includes the following information: What is a healthy relationship? Healthy communication for healthy relationships, Maintaining healthy relationships, Relationship issues, and a list of resources for support and further related information.
The website will be available for the 6 months of the implementation period.


Control group
Active

Outcomes
Primary outcome [1] 331373 0
Percentage of men who self-report undertaking help seeking behaviours for relationship issues in the last six months (as measured by an audit of records to men's self reported use of Men’s Referral Service, MensLine, Men's Behaviour Change Programs and other counselling services for relationships) .
Timepoint [1] 331373 0
baseline, 6 months after baseline.
Secondary outcome [1] 409642 0
Awareness of behaviours in relationships as abusive as measured by the Understanding Violence against Women scale from The National Community Attitudes Survey, (Webster et al, 2014)
Timepoint [1] 409642 0
baseline, immediately post-use of website.
Secondary outcome [2] 409643 0
Mean score on Readiness to Change scale as measured by 10 items adapted from The Contemplation Ladder (Biener & Abrams, 1991; Slavet et al, 2006).
Timepoint [2] 409643 0
baseline, immediately post-use of website, and 3 months after baseline

Eligibility
Key inclusion criteria
To be included in the study, a person must:
· Identify as a male
· Live in Australia
· Be aged from 18 to 50 years
· Report concerns about his behaviours towards any partner or concerns by others about his behaviour in the last twelve months
· Have safe access to a computer or similar device and an internet connection
· Provide a current valid email address and mobile number

All men who fulfil the eligibility criteria (and give informed consent) will be included in the study.

As part of the evaluation, 15% of female or male partners of men will be surveyed if they are English speaking and the male participant provides partner contact details for them to be invited to receive study information.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those people who cannot read in English, or have cognitive ability to answer the surveys will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligibility will be determined online prior to randomisation by the computer. All BETTER MAN Chief Investigators and the research team will be blinded to the allocation of participants, until after collection and analysis of the 6-month data; an administrator not connected to the research team will implement the randomisation process, and will be unblinded to the participants allocation. Until this time, the two groups will be referred to in tracking systems and other data collection as Group A and Group B (with the intervention group randomly allocated to either letter by the administrator).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned with a 1:1 allocation ratio automatically after they complete the baseline measures for BETTER MAN using blocked randomisation using permuted blocks of random sizes. To ensure concealment, the block sizes will be concealed. The allocation schedule will be computer generated by the statistician and uploaded into the REDCAP randomisation module.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Participants characteristics in each of the two study groups will be summarised using means and standard deviations (or percentiles as appropriate) for continuous data, and frequencies and percentages for categorical data. Primary analysis will use an intention to treat approach, where all individuals will be included in the analysis according to the study group they were assigned, whether they completed all, part or none of the intended intervention.

For the primary analysis, we will use logistic regression to estimate the odds ratio of men’s help seeking activities at 6 months for the intervention against the comparison group. Generalised linear model with the identity link function and binomial family will be used to estimate the absolute difference in the percentage of men’s help seeking activities between the two-study groups. Both models will adjust for whether the participant had children or did not have children at baseline. The estimated intervention effect for the primary outcome will be presented as both an odds ratio (relative effect) and between-group difference in the percentages (absolute effect) with their respective 95% confidence interval (CI), and the p-value estimated using logistic regression.

For secondary outcomes, linear mixed effects linear regression model to estimate the difference in the mean scores between the two study groups on continuous outcomes. Study group and time of measurement (baseline, immediate post-intervention, 3 and 6 months) will be included as fixed effect and random intercept terms for individuals (to account for the repeated measurement on individuals). A two-way interaction between the study group and time will be fitted to estimate the between-group difference in mean outcome at each measurement time point, but we will constrain the baseline means between the study groups to be equal. The estimates for the continuous secondary outcomes will be presented as difference in the mean outcome between the intervention and comparison groups at immediate post-intervention, 3 and 6 months, with 95% confidence intervals and p-values.

Marginal logistic regression using Generalised Estimating Equations with robust standard errors will be used to compare the two study groups on secondary binary outcomes, with study group and time point of measurement as fixed effects. Similarly, the estimates for the binary secondary outcomes will be presented as odds ratio comparing the intervention to the comparison group at immediate post-intervention, 3 and 6 months, with respective 95% confidence intervals and p-values.

All regression models for secondary outcomes will include whether the participants had children or no children and baseline outcome measure (when appropriate) as covariates.

Sensitivity analyses will adjust for variables measured at baseline strongly correlated with the outcome.

We will use multiple imputation to address bias due to attrition for the primary and secondary outcomes. We will use complier average casual effect (CACE) analysis to investigate the effects of non-adherence to the intervention on the estimated intervention effects. Details of these missing imputation approach and CACE analysis will be provided in a statistical analysis plan (SAP) that will be made available prior to the statistical analysis of the primary and secondary outcomes. The SAP will also elaborate on other additional analyses such sensitivity analyses to assess robustness of missing data assumption and sub-group analysis.

Economic evaluation:
For the economic evaluation, resource use data from website software and men’s self-report will be valued at standard unit cost rates to estimate intervention delivery costs and impact of the intervention on costs of access/use and service use over the six months from the perspective of (i) government and (ii) men. The six-month time duration avoids the need for discounting. Economic evaluation will, as a first step, present a cost-consequences analysis with costs presented separately for government and men compared with the difference in all outcome measures.

All analyses will be conducted in Stata Statistical software 17 (StataCorp. 2021) .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/06/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311371 0
Government body
Name [1] 311371 0
NATIONAL HEALTH & MEDICAL RESEARCH COUNCIL
Country [1] 311371 0
Australia
Primary sponsor type
Individual
Name
Kelsey Hegarty
Address
Department of General Practice, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
780 Elizabeth St, Carlton, Melbourne Victoria, 3053
Country
Australia
Secondary sponsor category [1] 312760 0
Individual
Name [1] 312760 0
Laura Tarzia
Address [1] 312760 0
Department of General Practice, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
780 Elizabeth St, Carlton, Melbourne Victoria, 3053
Country [1] 312760 0
Australia
Secondary sponsor category [2] 312908 0
Individual
Name [2] 312908 0
Cathy Humphreys
Address [2] 312908 0
Department of Social Work, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne,
Grattan Street, Parkville, Melbourne Victoria, 3010
Country [2] 312908 0
Australia
Secondary sponsor category [3] 312911 0
Individual
Name [3] 312911 0
Elizabeth Murray
Address [3] 312911 0
Institute of Healthcare Engineering, University College London.
Gower Street, London, WC1E 6BT
Country [3] 312911 0
United Kingdom
Secondary sponsor category [4] 312912 0
Individual
Name [4] 312912 0
Mohajer Hameed
Address [4] 312912 0
The Bouverie Centre, School of Psychology and Public Health, La Trobe University
Level 20, 360 Collins Street, Melbourne Victoria 3000
Country [4] 312912 0
Australia
Secondary sponsor category [5] 312913 0
Individual
Name [5] 312913 0
Gene Feder
Address [5] 312913 0
Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol
Beacon House, Queens Road, Bristol, BS8 1QU, UK
Country [5] 312913 0
Australia
Secondary sponsor category [6] 312914 0
Individual
Name [6] 312914 0
Lisa Gold
Address [6] 312914 0
Deakin Health Economics, School of Health & Social Dev, Faculty of Health, Deakin University
221 Burwood Hwy, Burwood Melbourne Victoria, 3125
Country [6] 312914 0
Australia
Secondary sponsor category [7] 312915 0
Individual
Name [7] 312915 0
Patty (Panagiota) Chondros
Address [7] 312915 0
Department of General Practice, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
780 Elizabeth St, Carlton, Melbourne Victoria, 3053
Country [7] 312915 0
Australia
Secondary sponsor category [8] 312916 0
Individual
Name [8] 312916 0
Simone Tassone
Address [8] 312916 0
Centre for Workforce Excellence, Policy and Design, Family Safety Victoria
GPO Box 4912, Melbourne Victoria 3001
Country [8] 312916 0
Australia
Other collaborator category [1] 282318 0
Individual
Name [1] 282318 0
Carolina Navarro Medel
Address [1] 282318 0
Department of General Practice, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
780 Elizabeth St, Carlton, Melbourne Victoria, 3053
Country [1] 282318 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310861 0
Science, Technology, Engineering, Mathematics and Medicine (STEMM 2)
Ethics committee address [1] 310861 0
Ethics committee country [1] 310861 0
Australia
Date submitted for ethics approval [1] 310861 0
10/12/2021
Approval date [1] 310861 0
10/03/2022
Ethics approval number [1] 310861 0
2022-22745-26160-3

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

Contacts
Principal investigator
Name 119130 0
Prof Kelsey Hegarty
Address 119130 0
Department of General Practice, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
780 Elizabeth St, Carlton, Melbourne Victoria, 3053
Country 119130 0
Australia
Phone 119130 0
+61 401488304
Fax 119130 0
Email 119130 0
[email protected]
Contact person for public queries
Name 119131 0
Carolina Navarro Medel
Address 119131 0
Department of General Practice, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
780 Elizabeth St, Carlton, Melbourne Victoria, 3053
Country 119131 0
Australia
Phone 119131 0
+61413914630
Fax 119131 0
Email 119131 0
[email protected]
Contact person for scientific queries
Name 119132 0
Kelsey Hegarty
Address 119132 0
Department of General Practice, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne
780 Elizabeth St, Carlton, Melbourne Victoria, 3053
Country 119132 0
Australia
Phone 119132 0
+61 401488304
Fax 119132 0
Email 119132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data underlying published results.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publications.
Available to whom?
Case by case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Prinicipal investigator Kelsey Hegarty [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16065Study protocol  [email protected]
16066Statistical analysis plan  [email protected]
16067Informed consent form    384018-(Uploaded-13-05-2022-17-43-24)-Study-related document.docx
16068Ethical approval    384018-(Uploaded-13-05-2022-17-41-13)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.