Trial Review

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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] 291372 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Help-seeking 302365 0
Suicidality 302366 0
Condition category
Condition code
Mental Health 301951 301951 0 0
Suicide
Public Health 302594 302594 0 0
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] 297406 0
Prevention
Intervention code [2] 297981 0
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] 301371 0
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] 301371 0
Help seeking intentions will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.
Secondary outcome [1] 332454 0
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] 332454 0
Psychological distress will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.
Secondary outcome [2] 333382 0
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] 333382 0
Suicidal ideation will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.
Secondary outcome [3] 333383 0
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] 333383 0
Help-seeking behaviours will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.
Secondary outcome [4] 333621 0
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] 333621 0
Help-seeking attitudes will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.
Secondary outcome [5] 334033 0
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] 334033 0
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] 334034 0
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] 334034 0
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] 334035 0
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] 334035 0
Confidence in supporting peers will be assessed 1 week pre-intervention, 1 week post-intervention and 3 months post-intervention.
Secondary outcome [8] 334036 0
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] 334036 0
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] 295844 0
Charities/Societies/Foundations
Name [1] 295844 0
Australian Rotary Health
Country [1] 295844 0
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] 294697 0
None
Name [1] 294697 0
Address [1] 294697 0
Country [1] 294697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297126 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 297126 0
Ethics committee country [1] 297126 0
Australia
Date submitted for ethics approval [1] 297126 0
05/01/2017
Approval date [1] 297126 0
07/02/2017
Ethics approval number [1] 297126 0
2017/004

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

Contacts
Principal investigator
Name 73066 0
Dr Alison Calear
Address 73066 0
Centre for Mental Health Research
Building 63
Eggleston Road
Acton ACT 2601
Country 73066 0
Australia
Phone 73066 0
+61 2 6125 8406
Fax 73066 0
Email 73066 0
[email protected]
Contact person for public queries
Name 73067 0
Alyssa Morse
Address 73067 0
Centre for Mental Health Research
Building 63
Eggleston Road
Acton ACT 2601
Country 73067 0
Australia
Phone 73067 0
+61 2 6125 6167
Fax 73067 0
Email 73067 0
[email protected]
Contact person for scientific queries
Name 73068 0
Alison Calear
Address 73068 0
Centre for Mental Health Research
Building 63
Eggleston Road
Acton ACT 2601
Country 73068 0
Australia
Phone 73068 0
+61 2 6125 8406
Fax 73068 0
Email 73068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
1820Study 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
SourceTitleYear of PublicationDOI
EmbaseGender norms and the mental health of boys and young men.2021https://dx.doi.org/10.1016/S2468-2667%2821%2900138-9
EmbaseGender norms and the wellbeing of girls and boys.2021https://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.