Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001134910
Ethics application status
Approved
Date submitted
2/09/2020
Date registered
30/10/2020
Date last updated
15/08/2023
Date data sharing statement initially provided
30/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomised control trial of the impact of the ‘Breaking the Man Code’ workshops on adolescent boys’ intentions to seek help
Scientific title
A cluster randomised control trial of the impact of the ‘Breaking the Man Code’ workshops on adolescent boys’ intentions to seek help
Secondary ID [1] 302213 0
None
Universal Trial Number (UTN)
U1111-1253-6472
Trial acronym
None
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Mental health 318908 0
Suicide 318909 0
Condition category
Condition code
Public Health 316886 316886 0 0
Health promotion/education
Mental Health 317521 317521 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: The ‘Breaking the Man Code’ Workshops delivered by Tomorrow Man to male secondary school students in Australia.

One workshop delivered to year 10, 11 or 12 male secondary school students in Australia by a trained facilitator from Tomorrow Man (tomorrowman.com.au). The workshop is usually provided within school class time to male students of one year level at secondary school and comprises interactive group activities. The workshop delivery is face-to-face or online and takes approximately 2 hours. Each workshop includes between 30 to 35 male students, with an average of three workshops to three different groups of students, totalling an average of 100 students per school. Multiple workshops at the one school are usually delivered by the one facilitator. The workshop explores the impact of the ‘man code’ – the unwritten rules about how to be a man – on the wellbeing of Australian men. It explores who wrote the rules and investigates why men feel obliged to live up to gender expectations and stereotypes. The workshop then allows boys to open up about their experience living with the ‘man code’ in order to understand that they can write their own rules. The workshop aims to lessen the negative impact of some masculine norms and to develop protective factors such as positive attitudes towards help-seeking, emotional expressiveness, and social support. Students will complete a baseline questionnaire approximately 2 weeks prior to the workshop and a follow-up questionnaire 2-6 weeks after the workshop. Adherence to the intervention will not be monitored.
Intervention code [1] 318504 0
Prevention
Intervention code [2] 318505 0
Lifestyle
Comparator / control treatment
Students in the control group will receive their usual curriculum during the 8-week data collection period. They will receive the workshop after the questionnaires have been completed.
Control group
Active

Outcomes
Primary outcome [1] 324990 0
Difference between the two study arms for mean change in intentions to seek help, as measured by an adapted version of the General Help Seeking Questionnaire (GHSQ) (Wilson et al. 2005. Measuring help seeking intentions: Properties of the General Help Seeking Questionnaire. Canadian Journal of Counselling, Vol. 39(1), 15-28.). The GHSQ has been found to have reliability and validity, and to be a suitable measure of help-seeking intentions in a range of contexts. Item or total scores can be used in analysis, and the scale can be modified to add in extra response items. The GHSQ asks participants: “If you were having a personal or emotional problem, how likely is it that you would seek help from the following people or services?” Response options include: an intimate partner; friend; parent; other relative; mental health professional; doctor; or minister or religious leader. The following additional response options will be included: phone helpline; people online; and someone at school. The final scale comprises 10 items and participants responded on a seven-point Likert scale (range 10-70). Higher scores reflect higher intentions to seek help.
Timepoint [1] 324990 0
Following randomisation of schools, the baseline assessment for the intervention group will occur within the two weeks prior to receiving the workshop. The follow-up assessment will then occur two to six weeks after the workshop. For the control group, following randomisation, the baseline assessment and follow-up assessment will be four to eight weeks apart, with usual school curriculum in-between.
Secondary outcome [1] 386469 0
Difference between the two study arms in mean change of conformity to masculine norms as measured by the Conformity to Masculine Norms Inventory (Mahalik et al. (2003). Development of the Conformity to Masculine Norms Inventory. Psychology of Men & Masculinity, 4: 3-25). The Conformity to Masculine Norms Inventory (CMNI-22) is a 22-item scale will assess participants’ conformity to 11 potentially harmful masculine norms: emotional control; risk-taking; violence; dominance; playboy; self-reliance; primary of work; power over women; heterosexual presentation; physical toughness; and pursuit of status (Mahalik et al., 2003). Items are answered on a 4-point likert scale (0 = strongly disagree to 3 = strongly agree), range 0 – 66. Higher scores indicate higher conformity to masculine norms. The CMNI-22 has been found to have good internal consistency, differential validity, and test-retest reliability (Mahalik et al. 2003). The playboy subscale questions and one of the power over women subscale questions were modified for suitability in a school population. ‘I would feel good if I had many sexual partners’ to ‘I would feel good if I had many girlfriends/boyfriends’ ‘If I could I would frequently change sexual partners’ to ‘If I could I would frequently change girlfriends/boyfriends’ 'I love it when men are in charge of women' to 'I think it is okay for men to be in charge of women'
Timepoint [1] 386469 0
Following randomisation of schools, the baseline assessment for the intervention group will occur within the two weeks prior to receiving the workshop. The follow-up assessment will then occur two to six weeks after the workshop. For the control group, following randomisation, the baseline assessment and follow-up assessment will be four to eight weeks apart, with usual school curriculum in-between.
Secondary outcome [2] 386470 0
Difference between the two study arms in mean change in depression risk as measured by the Male Depression Risk Scale (Herreen D, Rice SM, Zajac I. Development and Validation of the MDRS Short Form for Clinical Use. In preparation.) This 7-item scale was chosen to capture the externalising symptoms of depression common to males - emotional suppression, drug use, alcohol use, anger and aggression, somatic symptoms, and risk taking (in the last two weeks). Items are answered on an 5-point Likert scale (0 = none of the time to 4 = all of the time), range 0 – 28. High scores indicate higher depression risk.
Timepoint [2] 386470 0
Following randomisation of schools, the baseline assessment for the intervention group will occur within the two weeks prior to receiving the workshop. The follow-up assessment will then occur two to six weeks after the workshop. For the control group, following randomisation, the baseline assessment and follow-up assessment will be four to eight weeks apart, with usual school curriculum in-between.
Secondary outcome [3] 386471 0
Difference between the two study arms in mean change in subjective social support as measured by the emotional/informational subscale of the Medical Outcomes Study Social Support Survey (MOS-SS). Moser A, Stuck AE, Silliman RA, Ganz PA, Clough-Gorr KM. The eight-item modified Medical Outcomes Study Social Support Survey: psychometric evaluation showed excellent performance. J Clin Epidemiol. 2012;65(10):1107-16. This 8-item subscale asks participants about the kind of support available to them. The items are answered using a 5-point Likert scale (1 = none of the time to 5 = all of the time), range 8 - 40. Higher scores reflect high levels of perceived support. The scale has been found to have good psychometric properties among young non-clinical populations. (Giangrasso & Casale, 2014).
Timepoint [3] 386471 0
Following randomisation of schools, the baseline assessment for the intervention group will occur within the two weeks prior to receiving the workshop. The follow-up assessment will then occur two to six weeks after the workshop. For the control group, following randomisation, the baseline assessment and follow-up assessment will be four to eight weeks apart, with usual school curriculum in-between.
Secondary outcome [4] 386472 0
Difference between the two study arms in mean change in quality of life as measured by the the Child Health Utility Instrument (CHU9D). Stevens K. Assessing the performance of a new generic measure of health-related quality of life for children and refining it for use in health state valuation. Applied health economics and health policy. 2011;9(3):157-69. This 9-item scale asks participants about their functioning today across domains of worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine, activities. The items are answered using a 5-level response category (1 = I don’t feel X today to 5 = I feel very X today). The CHU9D has been recommended for measuring quality of life in adolescent populations in Australia (Chen et al, 2015).
Timepoint [4] 386472 0
Following randomisation of schools, the baseline assessment for the intervention group will occur within the two weeks prior to receiving the workshop. The follow-up assessment will then occur two to six weeks after the workshop. For the control group, following randomisation, the baseline assessment and follow-up assessment will be four to eight weeks apart, with usual school curriculum in-between.
Secondary outcome [5] 401675 0
The CHU9D will also be used to derive health state utility values by using the previous published value set, reflecting Australian adolescents’ preferences, which will be combined with the period of the trial to derive QALYs (Ratcliffe J, Huynh E, Chen G, Stevens K, Swait J, Brazier J, et al. Valuing the Child Health Utility 9D: Using profile case best worst scaling methods to develop a new adolescent specific scoring algorithm. Soc Sci Med. 2016;157:48-59.) Health service use will be assessed using a modified Resource Utilization Questionnaire (RUQ) (Smaldone A, Tsimicalis A, Stone PW. Measuring resource utilization in patient-oriented comparative effectiveness research: a psychometric study of the Resource Utilization Questionnaire. Res Theory Nurs Pract. 2011;25(2):80-106.) The 21-item questionnaire was developed to measure the health services and costs of health care. This questionnaire has been modified from the version used in the Young Minds Matter Survey to enable self-report by adolescents and will ask which health professionals participants have seen in the past two weeks for their mental health (number of the visits, location and costs of visits), and medications taken for emotional or behavioural concerns in the past two weeks (type, dosage) ( Hafekost J, Lawrence D, Boterhoven de Haan K, Johnson SE, Saw S, Buckingham WJ, et al. Methodology of Young Minds Matter: The second Australian Child and Adolescent Survey of Mental Health and Wellbeing. Aust N Z J Psychiatry. 2016;50(9):866-75.). Resource use and unit costs will be combined to derive a total cost for each participant. The standard Australian unit costs of relevant resource use units collected through the RUQ will be extracted from different sources include the Independent Hospital Pricing Authority, the Medicare/Pharmaceutical Benefit Scheme fees and State-based services.
Timepoint [5] 401675 0
Following randomisation of schools, the baseline assessment for the intervention group will occur within the two weeks prior to receiving the workshop. The follow-up assessment will then occur two to six weeks after the workshop. For the control group, following randomisation, the baseline assessment and follow-up assessment will be four to eight weeks apart, with usual school curriculum in-between.

Eligibility
Key inclusion criteria
School inclusion:
1. Request a ‘Breaking the Man Code’ workshop for their year 10, 11 or 12 males in 2021 or 2022.
2. Agree to schedule the workshop within either the intervention period or wait list period as instructed by the researchers.
3. Agree to distribute study information to parents of boys enrolled in the workshop and to allocated two class times, four to six weeks apart, for students to complete the baseline and follow-up questionnaire.

Student inclusion:
1. Student within a participating school in years 10, 11 or 12.
2. Enrolled to take part in a workshop
3. Parent has provided consent for them to take part in the trial
4. Student provides assent to take part in the trial
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There will be no exclusion criteria. All students enrolled in a ‘Breaking the Man Code’ Workshop at included schools will be eligible for inclusion in the trial.

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)
Allocation will involve contacting the holder of the allocation schedule who will be “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

The trial will use a stratified design where schools will be stratified by location (state and rurality) and delivery mode (face-to-face or online) and then within the strata schools will be randomly allocated to either the intervention group or the wait list control group.
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
Efficacy
Statistical methods / analysis
For 90% power and a two-sided 5% significance level, we will require a sample of 1000 participants across 40 schools (a minimum of 25 students on average per school) to detect a standardised effect size of 0.3 in mean GHSQ score between the study arms. Sample size accounts for the correlation of outcomes within schools in 0.03 (Lane et al., 2018), and assumes that 20% of students do not respond at follow-up and includes two additional schools (one school in each arm) to allow for potential loss to follow-up of schools post-randomisation.

Descriptive statistics will be used to summarise school and participant characteristics between study arms. Analysis will use an intention to treat approach. We will use linear mixed effect models to estimate the difference in mean GHSQ scores at follow-up between the study groups, with random effects for school and fixed effects for study group, baseline GHSQ scores, and stratification factors. Estimated intervention effect will be reported as difference in mean GHSQ scores between intervention and control groups, with 95% confidence interval and p-value. We will undertake a similar analysis for secondary outcomes. Strategies will be undertaken to minimise missing data, and sensitivity analyses will be conducted to assess the robustness of the missing data assumption. A full statistical analysis plan will be developed adhering the SPIRIT statement. We will analyse responses to open-ended questions using inductive thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/04/2021
Actual
27/04/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
8/05/2023
Date of last data collection
Anticipated
Actual
26/06/2023
Sample size
Target
1000
Accrual to date
Final
1235
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 306633 0
Charities/Societies/Foundations
Name [1] 306633 0
Australian Rotary Health
Country [1] 306633 0
Australia
Funding source category [2] 309844 0
Government body
Name [2] 309844 0
Australian Government National Health and Medical Research Council, Medical Research Future Fund
Country [2] 309844 0
Australia
Primary sponsor type
Individual
Name
Dr Kylie King
Address
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University, Clayton Campus
18 Innovation Walk
Clayton VIC 3800
Australia
Country
Australia
Secondary sponsor category [1] 307183 0
None
Name [1] 307183 0
Address [1] 307183 0
Country [1] 307183 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306819 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 306819 0
Ethics committee country [1] 306819 0
Australia
Date submitted for ethics approval [1] 306819 0
Approval date [1] 306819 0
20/02/2020
Ethics approval number [1] 306819 0
22796

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

Contacts
Principal investigator
Name 105118 0
Dr Kylie King
Address 105118 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University, Clayton Campus
18 Innovation Walk
Clayton VIC 3800
Country 105118 0
Australia
Phone 105118 0
+61399052389
Fax 105118 0
Email 105118 0
[email protected]
Contact person for public queries
Name 105119 0
Kylie King
Address 105119 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University, Clayton Campus
18 Innovation Walk
Clayton VIC 3800
Country 105119 0
Australia
Phone 105119 0
+61399052389
Fax 105119 0
Email 105119 0
[email protected]
Contact person for scientific queries
Name 105120 0
Kylie King
Address 105120 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University, Clayton Campus
18 Innovation Walk
Clayton VIC 3800
Country 105120 0
Australia
Phone 105120 0
+61399052389
Fax 105120 0
Email 105120 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?
De-identified individual quantitative participant data collected during the trial underlying published results.
When will data be available (start and end dates)?
Following main results publication, no end date determined.
Available to whom?
Only researchers who can provide a methodologically sound proposal and who have ethics approval from a research institution. This will be determined on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
The data will be stored in the Monash University Research Repository. Access will be subject to approvals by the Principal Investigator:

Dr Kylie King
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University, Clayton Campus
18 Innovation Walk
Clayton VIC 3800
Australia

Phone +61 3 9905 2389
Email: [email protected]


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9020Ethical approval  [email protected] By email to the Principal Investigator
20018Statistical analysis plan    380515-(Uploaded-04-07-2023-11-16-47)-Study-related document.pdf
20019Data dictionary    380515-(Uploaded-04-07-2023-11-18-27)-Study-related document.pdf
20020Data dictionary    380515-(Uploaded-04-07-2023-11-19-25)-Study-related document.pdf
20021Study protocolKing, K., Schlichthorst, M., Chondros, P. et al. Protocol for a cluster randomized control trial of the impact of the Breaking the Man Code workshops on adolescent boys’ intentions to seek help. Trials 23, 110 (2022). https://doi.org/10.1186/s13063-022-06034-0https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06034-0 


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9020Ethical approval  [email protected] By email to the Principal Investigator
20018Statistical analysis plan    380515-(Uploaded-04-07-2023-11-16-47)-Study-related document.pdf
20019Data dictionary    380515-(Uploaded-04-07-2023-11-18-27)-Study-related document.pdf
20020Data dictionary    380515-(Uploaded-04-07-2023-11-19-25)-Study-related document.pdf
20021Study protocolKing, K., Schlichthorst, M., Chondros, P. et al. Protocol for a cluster randomized control trial of the impact of the Breaking the Man Code workshops on adolescent boys’ intentions to seek help. Trials 23, 110 (2022). https://doi.org/10.1186/s13063-022-06034-0https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06034-0 
New Record*Statistical analysis plan  [email protected] 380515-(Uploaded-24-10-2024-12-47-16)-BTMC_SAP_V1.1.docx

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a cluster randomized control trial of the impact of the Breaking the Man Code workshops on adolescent boys' intentions to seek help.2022https://dx.doi.org/10.1186/s13063-022-06034-0
N.B. These documents automatically identified may not have been verified by the study sponsor.