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Trial registered on ANZCTR

Registration number

ACTRN12617000658314

Ethics application status

Approved

Date submitted

28/04/2017

Date registered

8/05/2017

Date last updated

22/04/2020

Date data sharing statement initially provided

10/04/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Measuring the effects of the Silence is Deadly program on mental help-seeking attitudes in young men

Scientific title

Silence is Deadly: A controlled trial to measure the effects of a male-tailored intervention program on mental health help-seeking attitudes in young men

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Help-seeking

Suicidality

Condition category

Condition code

Mental Health

Suicide

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Silence is Deadly: a young male tailored intervention

Silence is Deadly is a multicomponent intervention delivered in schools that consists of a one-hour presentation to groups of students, supporting website, videos, informational handouts and wristbands to show support for the cause. The program will be delivered by a Menslink staff member. Participants are not instructed or required to access the Silence is Deadly website. However, they are free to access the website at any time. The informational handouts are designed specifically for the Silence is Deadly intervention by Menslink. This program has been delivered in Australian Capital Territory schools since 2014 by the organisation Menslink, which was established in 2002. Similar to other programs in this field, it employs a psychoeducational design in which key statistics are presented which normalise the existence of mental health issues and identify the issue of low help-seeking rates among men. Importantly, it also includes components of contact, role modelling and social norming. These additional components are delivered in partnership with the local state representative rugby league team (the Canberra Raiders). Their involvement comprises a video, in which celebrity players discourage the existing male norms that prevent positive help-seeking attitudes and instead support the importance of communicating about personal issues. Further, junior players attend the intervention (classroom session) in person and speak about their positive help-seeking behaviours in response to personal experiences of dealing with tough times (sub-clinical or undiagnosed mental health issues which resulted from incidents such as bullying, injuries, relationships and other circumstantial stressors). The topic of how to help a mate (i.e., start a conversation), is also discussed and there is a question and answer session at the conclusion of the session which lasts 5-15 minutes. Overall, the effectiveness of the intervention is thought to consist of normalising the occurrence of mental health issues and altering attitudes towards them by reframing them in the context of broader help-seeking norms for personal problems, which are less stigmatised and less gender-role conflicting.

Participants will receive one group, face-to-face, 45-60 minute session of the Silence is Deadly program at their high school.. Adherence and fidelity will not be assessed. Adherence is unlikely to be an issue as the intervention is a single session presented as a school activity. Silence is Deadly is delivered by experienced presenters who are co-developers of the program content, this maintains the fidelity of the program at each presentation session.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

Wait list: The wait-list control condition will continue usual school activities during the intervention phase of the trial and will receive the program after all surveys have been administered - roughly 3 and a half months after the first survey.

Control group

Active

Outcomes

Primary outcome [1]

Help-seeking intentions

The adapted version of the General Help-Seeking Questionnaire (GHSQ; Wilson et al, 2005) is the primary outcome measure in the current study and assesses intentions to seek help for personal or emotional problems from 11 different formal and informal sources (e.g., friend, parent, psychologist, teacher). Respondents indicate how likely they are to seek help from each of the sources on a scale ranging from 1 (extremely unlikely) to 7 (extremely likely).. This scale will detect any change in help-seeking intentions following the intervention.

Timepoint [1]

Help seeking intentions will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [1]

Psychological distress

General psychological distress will be assessed with the newly developed Distress Questionnaire Scale – 5 (DQ5). This scale assesses levels of distress and common mental health problems, and will be used to detect any change in distress following the intervention.

Timepoint [1]

Psychological distress will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [2]

Suicidal ideation

One item from the Youth Risk Behaviour Survey (YRBS) will be administered to assess if the respondent has had suicidal ideation during the past 12 months. This item will be administered to detect any change in disclosure of suicidal ideation following the intervention, and allow investigation of any mediating relationship of suicidal ideation on the outcomes of the program.

Timepoint [2]

Suicidal ideation will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [3]

Change in help-seeking behaviours

Recent help-seeking behaviours will be measured using an adapted version of the Actual Help-Seeking Questionnaire (AHSQ). The AHSQ assesses recent actual help-seeking behaviour and consists of the same 11 sources of help as the GHSQ, in which the respondent either does or does not report having sought help from for a mental health problem in the past 3 months. This measure will allow assessment of change in help-seeking behaviours following the intervention.

Timepoint [3]

Help-seeking behaviours will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [4]

Help-seeking attitudes

The Attitudes Toward Seeking Psychological Professional Help: Shortened Form (ATSPPH-SF) measures respondents’ attitudes regarding self-reliance and professional support for personal and emotional problems. Attitudes to professional psychological help are measured by 10 items on a 4-point scale ranging from 0 (disagree) to 3 (agree). This measure will allow assessment of change in attitudes toward help-seeking following the intervention.

Timepoint [4]

Help-seeking attitudes will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [5]

Self-stigma of professional help-seeking

The Self-Stigma of Seeking Help Scale (SSoSHS) measures respondents’ self-stigma around seeking professional support for personal and emotional problems. Self-stigma for seeking professional psychological help is measured by 10 items on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). This measure will allow assessment of change in self-stigma regarding help-seeking from professional sources following the intervention.

Timepoint [5]

Self-stigma of professional help-seeking will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [6]

Attitudes to seeking support from trusted adults

Respondents’ attitudes towards seeking support from trusted adults in their lives will be assessed using 4 items on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). This scale also assesses respondents’ view of their family’s and friends’ norms regarding seeking help and support from trusted adults. This measure will allow assessment of change in attitudes to seeking support from trusted adults following the intervention.

Timepoint [6]

Attitudes to seeking support from trusted will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [7]

Confidence in supporting peers

One measure has been adapted from the Mental Health First Aid literature to assess respondents’ confidence in asking peers or friends if they are experiencing difficulties, and their confidence to assist others in seeking support. This will allow assessment of change in respondents’ level of confidence to discuss problems and support their peers in help-seeking.

Timepoint [7]

Confidence in supporting peers will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.

Secondary outcome [8]

Qualitative evaluations The trial will also collect qualitative data to evaluate the Silence is Deadly program. Semi-structured interviews or qualitative surveys will be conducted with key staff members to investigate perceived changes in student help-seeking and school culture following the program. Students in intervention schools will also respond to open-ended evaluation questions after receiving the program.

Timepoint [8]

Staff interviews/surveys will be conducted after 3-month follow-up, and student evaluations will be delivered at 1-week post-intervention in intervention schools.

Eligibility

Key inclusion criteria

Male high school students in years 7-12

Minimum age

12 Years

Maximum age

18 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Female students will be excluded

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size:
A sample of 660 adolescents from 12 high schools (55 students per school) will be recruited to participate in the current study. Calculation of the required sample size was based on detecting a small-moderate post-intervention effect size of f=0.2. Assuming correlation between repeated measures of 0.5, intra-class correlation of 0.03 (accounting for clustering within schools) and 20% attrition, we will have >85% power to find a small difference (Cohens f=0.2) between groups.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

15/05/2017

Actual

31/05/2017

Date of last participant enrolment

Anticipated

15/04/2019

Actual

2/04/2019

Date of last data collection

Anticipated

31/05/2019

Actual

2/04/2019

Sample size

Target

660

Accrual to date

Final

594

Recruitment in Australia

Recruitment state(s)

ACT

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health

Address [1]

2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Country [1]

Australia

Primary sponsor type

University

Name

The Centre for Mental Health Research, The Australian National University

Address

Building 63
Eggleston Road
Acton ACT 2601

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian National University Human Research Ethics Committee

Ethics committee address [1]

The Australian National University
ACTON ACT 0200

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/01/2017

Approval date [1]

07/02/2017

Ethics approval number [1]

2017/004

Summary

Brief summary

The largest mortality risk facing young men is suicide, and their unwillingness to seek help for their mental health troubles greatly exacerbates this problem. Rather than blame men for their poor attitudes, some organisations are changing the nature of the public health message directed at young men to make it more male friendly. It is not known whether these interventions are having a positive effect on mens help-seeking attitudes and intentions, particularly among young men with indicated mental health problems, those with more stigmatising attitudes, or those who conform more strongly to gender norms. The current research project seeks to evaluate one such existing intervention, the Silence is Deadly Program, which has been delivered in ACT schools since 2014. This intervention is delivered by not-for-profit organisation Menslink in partnership with the state representative rugby league team (the Canberra Raiders) and uses role-modelling and social norming, as well as male-tailored vocabulary, to influence young mens help-seeking attitudes and intentions.
The proposed research project will be conducted in 2017-2018, and will comprise a cluster randomised wait-list control trial that involves 8 ACT schools, totalling 800 male students who will be surveyed pre, post and three months after the intervention. The primary aim of the study is to determine the effectiveness of this tailored approach to suicide prevention and identify if it is differentially effective for participants with different levels of mental health symptoms, suicidal thoughts, stigmatizing attitudes towards seeking help and adherence to gender role norms. This analysis will be complemented by a qualitative investigation into the interventions effect on the culture of helping seeking in the school through semi-structured interviews with staff members. The research team has a strong track record of research in schools, service evaluation, stigma and help-seeking for mental health issues and suicide.

Trial website

Trial related presentations / publications

Calear, A. L., Banfield, M., Batterham, P. J., Morse, A. R., Forbes, O., Carron-Arthur, B., & Fisk. (2017). Silence is deadly: a cluster-randomised controlled trial of a mental health help-seeking intervention for young men. BMC Public Health, 17: 834. DOI 10.1186/s12889-017-4845-z

Public notes

Contacts

Principal investigator

Name

Dr Alison Calear

Address

Centre for Mental Health Research
Building 63
Eggleston Road
Acton ACT 2601

Country

Australia

Phone

+61 2 6125 8406

Fax

Alison.Calear@anu.edu.au

Contact person for public queries

Name

Alyssa Morse

Address

Centre for Mental Health Research
Building 63
Eggleston Road
Acton ACT 2601

Country

Australia

Phone

+61 2 6125 6167

Fax

alyssa.morse@anu.edu.au

Contact person for scientific queries

Name

Alison Calear

Address

Centre for Mental Health Research
Building 63
Eggleston Road
Acton ACT 2601

Country

Australia

Phone

+61 2 6125 8406

Fax

Alison.Calear@anu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The restrictions of our ethics protocol prevent us from making IPD available; participants did not consent to their data being made available beyond the research team.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1820	Study protocol				Calear, A. L., Banfield, M., Batterham, P. J., Mor... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Gender norms and the mental health of boys and young men.	2021	https://dx.doi.org/10.1016/S2468-2667%2821%2900138-9
Embase	Gender norms and the wellbeing of girls and boys.	2021	https://dx.doi.org/10.1016/S2214-109X%2820%2930551-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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