Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000916448
Ethics application status
Approved
Date submitted
28/06/2016
Date registered
11/07/2016
Date last updated
11/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Help Out a Mate: A trial of a brief sports-based mental health literacy program for young males
Scientific title
A Cluster-Randomised Controlled Trial of a Sports Based Mental Health Literacy Program to Promote Help-Seeking in Adolescent Males
Secondary ID [1] 289355 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 298985 0
Depression 299396 0
Anxiety 299397 0
Condition category
Condition code
Mental Health 299050 299050 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 299379 299379 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: “Help Out a Mate” – A brief sports based mental health literacy program for adolescent male athletes
Why:
Young males are reluctant to seek help for mental health problems. Only 65% of those with a mental health problem access health services. During formative research focus groups, the adolescent male athletes asked for more information about mental health problems, how to recognise them, and how they can help out their friends if they are experiencing a mental health problem. It has also been found that some of the most common reasons that young people who experience mental health problems do not seek professional help is due to stigma and poor mental health literacy (Lawrence et al., 2015). Around 70% of adolescents participate in organised sport in Australia. Delivery of a brief sports-based mental health literacy program has the potential to improve mental health literacy, reduce stigma and increase help seeking for mental health problems. Although adolescents prefer to disclose problems to their friends (Rickwood, Deane, Wilson, & Ciarrochi, 2005), they may not be equipped to appropriately respond to friends who are experiencing distress or mental health problems (Jorm, Wright, & Morgan, 2007; Rickwood, Deane, & Wilson, 2007; Yap, Wright, & Jorm, 2011). The "Help Out a Mate" mental health literacy presentation is aimed at increasing mental health literacy among adolescent males (specifically in regard to depression and anxiety), increase their skills and confidence to help a peer showing signs of a mental health problem, increase helping behaviour and supportive actions, increase appropriate help-seeking among young males at risk of mental health problems, and decrease stigmatising attitudes.
What:
This intervention will address the components of mental health literacy as proposed by Jorm (2012), with the content and structure developed on review of literature and current interventions including teen Mental Health First Aid and Insight, as well as guidelines and fact sheets developed by not-for-profit mental health organisations such as Reach Out, BeyondBlue, Headspace and the Black Dog Institute. Specifically, the intervention involves; (i) what is mental health and mental illness, (ii) myths about mental illness, (iii) what is depression?, (iv) what is anxiety?, and e) how to help, and where to get information. The program focuses on recognising signs, approaching the friend, encouraging help-seeking, making an adult aware of the mental health problem, not trying to fix their friend’s problem, and self-care and self-help behaviours. Additionally, the program addresses how to communicate that they are not "OK", and how to ask for help. A Man Card the size of a business card is provided and includes the main steps covered on how to help their friend as presented in the intervention, and referral information to other mental health resources.
How and Where:
This intervention will be delivered once using a face-to-face approach, conducted in a room at the athlete’s sports clubs to groups of around 10-15 adolescent male athletes. The program will be conducted by young male volunteers with lived mental health experience, as it has been found that a mixture of education and exposure to someone with a mental illness can effectively reduce stigma. The volunteers will be trained in Mental Health First Aid, facilitation in how to present the intervention, and have a current Working With Children Check.
When and How Much:
This intervention will be delivered towards the end of the sports season. Participants allocated to the intervention group will complete baseline data collection approximately 2 weeks prior to receiving the intervention. Measures will be taken again immediately following the intervention, and again at one-month follow-up. The control group will complete the measures at 3 time points before receiving the intervention. The program is designed to be delivered in a sport context and brief (approx. 45 minutes to one hour). The presentation will be presented during or around a team training session.
Tailoring:
The intervention will be delivered at a team level at one large soccer club, and tailoring will not be necessary.
How Well Planned:
Intervention adherence will be assessed by an observer involved in the project using an intervention protocol that volunteer facilitators could also follow. Directly after the intervention the athletes were asked to complete a short questionnaire.

References
Jorm, A. F. (2012). Mental Health Literacy: Empowering the Community to Take Action for Better Mental Health. American Psychologist, 67(3), 231-243.
Jorm, A. F., Wright, A., & Morgan, A. J. (2007). Where to seek help for a mental disorder? National survey of the beliefs of Australian youth and their parents. Medical Journal of Australia, 187(10), 556-560.
Lawrence, D., Johnson, S., Hafekost, J., Boterhoven de Haan, K., Sawyer, M. G., Ainley, J., & Zubrick, S. R. (2015). The Mental Health of Children and Adolescents: Report on the second Australian Child and Adolescent Survey of Mental Health and Wellbeing. Canberra.
Rickwood, D. J., Deane, F. P., & Wilson, C. J. (2007). When and how do young people seek professional help for mental health problems? Medical Journal of Australia, 187(7 (Suppl)), S35-S39.
Rickwood, D. J., Deane, F. P., Wilson, C. J., & Ciarrochi, J. (2005). Young People's Help-seeking for Mental Health Problems. Australian e-Journal for the Advancement of Mental Health, The, 4(3), 218-251.
Yap, M. B., Wright, A., & Jorm, A. F. (2011). First aid actions taken by young people for mental health problems in a close friend or family member: findings from an Australian national survey of youth. Psychiatry research, 188(1), 123-128.
Intervention code [1] 294938 0
Behaviour
Intervention code [2] 294939 0
Prevention
Comparator / control treatment
The intervention will be compared to a wait-list control, comprised of half of the teams from the participating soccer club, randomly allocated. Teams will be randomly allocated to receive the Help out a Mate presentation or to receive no presentation (Control). The control group will be offered the intervention after the one month follow-up surveys have been completed by both groups.
Control group
Active

Outcomes
Primary outcome [1] 298518 0
Mental health literacy as measured by the Mental Health Literacy Scale
Timepoint [1] 298518 0
Immediate post-intervention
Primary outcome [2] 298519 0
Confidence to help a peer, measured using a single item from the Mental Health Literacy Survey asking them to rate their confidence
Timepoint [2] 298519 0
Pre-intervention, post-intervention, and one-month follow-up.
Secondary outcome [1] 324439 0
Help-seeking intentions, measured by the General Help Seeking Questionnaire
Timepoint [1] 324439 0
Pre-intervention, post-intervention, and one-month follow-up.

Eligibility
Key inclusion criteria
Participate in soccer at the participating club.
Minimum age
12 Years
Maximum age
18 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females
Don't participate in sport
Aged younger than 12

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation sequence will be generated by the random sequence generation program "www.random.org". This will be conducted by an independent person who is not one of the researchers on the study. They will be provided with a list of team numbers clustered by age group and then asked to allocate teams within each cluster to the intervention or control condition.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
9/06/2016
Date of last participant enrolment
Anticipated
6/07/2016
Actual
6/07/2016
Date of last data collection
Anticipated
25/08/2016
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13412 0
2226 - Como
Recruitment postcode(s) [2] 13411 0
2226 - Jannali

Funding & Sponsors
Funding source category [1] 293738 0
Charities/Societies/Foundations
Name [1] 293738 0
Movember Foundation
Country [1] 293738 0
Australia
Primary sponsor type
Individual
Name
Dr Stewart Vella
Address
Early Start Research Institute, University of Wollongong, Northfields Avenue, Gwynneville, 2522 NSW
Country
Australia
Secondary sponsor category [1] 292567 0
Individual
Name [1] 292567 0
Prof Frank Deane
Address [1] 292567 0
Building 22, University of Wollongong, Northfields Avenue, Gwynneville, 2522 NSW
Country [1] 292567 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295176 0
UOW & ISLHD Human Research Ethics Committee
Ethics committee address [1] 295176 0
University of Wollongong, Northfields Avenue, Gwynneville, NSW 2522
Ethics committee country [1] 295176 0
Date submitted for ethics approval [1] 295176 0
07/12/2015
Approval date [1] 295176 0
18/12/2015
Ethics approval number [1] 295176 0
HE15/423

Summary
Brief summary
Help Out a Mate is a short (one hour) mental health literacy program that focuses on what mental health and mental illness is, specific disorders including depression and anxiety, how you could recognise these in a friend, and what to do if you do recognise it.

The aim of the program is to decrease mental health risk and stigma and increase skills to help out a friend, both on and off the field.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66226 0
Ms Sarah Liddle
Address 66226 0
Early Start Research Institute, University of Wollongong, Northfields Avenue, Gwynneville, 2522 NSW
Country 66226 0
Australia
Phone 66226 0
+61 2 42215624
Fax 66226 0
Email 66226 0
skl697@uowmail.edu.au
Contact person for public queries
Name 66227 0
Ms Sarah Liddle
Address 66227 0
Early Start Research Institute, University of Wollongong, Northfields Avenue, Gwynneville, 2522 NSW
Country 66227 0
Australia
Phone 66227 0
+61 2 42215624
Fax 66227 0
Email 66227 0
skl697@uowmail.edu.au
Contact person for scientific queries
Name 66228 0
Ms Sarah Liddle
Address 66228 0
Early Start Research Institute, University of Wollongong, Northfields Avenue, Gwynneville, 2522 NSW
Country 66228 0
Australia
Phone 66228 0
+61 2 42215624
Fax 66228 0
Email 66228 0
skl697@uowmail.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23435Ethical approval   

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4612Study results articleYes Liddle, S.K., Deane, F.P., Batterham, M., & Vella,... [More Details]

Documents added automatically
No additional documents have been identified.