Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000709347
Ethics application status
Approved
Date submitted
16/12/2016
Date registered
17/05/2017
Date last updated
10/07/2019
Date data sharing statement initially provided
10/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mental health and wellbeing in community sport: The Ahead of the Game program
Scientific title
Effect of a multi-component, sports-based mental health and wellbeing program for adolescent males: Ahead of the Game
Secondary ID [1] 290537 0
None
Universal Trial Number (UTN)
Trial acronym
AOTG
Linked study record
ACTRN12616000916448

Health condition
Health condition(s) or problem(s) studied:
Mental Health Literacy 300962 0
Resilience 300963 0
Mental Health 300964 0
Wellbeing 300965 0
Condition category
Condition code
Mental Health 300765 300765 0 0
Depression
Mental Health 300766 300766 0 0
Anxiety
Mental Health 300767 300767 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants (which include adolescent males, their parents, and their coaches) will be exposed to at least one program from a choice of four which will determined by their sporting club. Adolescents will be exposed to:
1. A brief (45 minute) mental health literacy program delivered face-to-face at a sporting club (called Help Out a Mate). Using the concept of mental health literacy, this program aims to increase 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.
Specifically, the intervention involves the following components which are delivered with the aid of a powerpoint presentation; (i) what is mental health and mental illness; (ii) myths about mental illness; (iii) what is depression?; (iv) what is anxiety?; (v) how to help; and, (vi) where to get information. The program focuses on helping adolescents to recognise the signs of depression and anxiety, approach a friend confidently, encouraging help-seeking, make an adult aware of potential mental health problems, and understand self-help behaviours. Additionally, the program teaches adolescents how to ask for help if they feel that they need it. In line with the overall program, additional resources are provided to the adolescents, including a ‘Man Card’ (business card) which includes the main steps on how to help their friend as presented in the intervention, and referral information to other mental health resources. The intervention also includes two ‘role play’ scenarios for participants to practice providing and asking for help.
The program is delivered face-to-face, and is usually conducted in a room at the athlete’s sports clubs to groups of approximately 5-20 adolescents. The program is usually conducted by young adult volunteers with lived experience of mental health problems, as it has been found that a mixture of education and exposure to someone with a mental illness can effectively reduce stigma. The volunteers are all trained in Mental Health First Aid. The program is designed to be brief (approx. 45 minutes) so that it could conveniently be placed in or around a typical training session.
In addition, the key messages of the program are reinforced with materials given to all adolescent participants. Specifically, each adolescent is provided with a boot bag (printed with ‘Help Out a Mate), drink bottle (printed with a list of healthy behaviours), z-card (with information on symptom recognition and help-seeking options), and stress ball (printed with the Ahead of the Game logo).
2. A brief (1 hour) resilience program delivered face-to-face at a sporting club and supplemented by 6 online/app modules (called Your Path to Success in Sport). The program aims to provide adolescent males with mental skills for coping with adversity and building resilience through sport. This sport psychology program consists of one face-to-face workshop (approximately one hour) supported by six 10 minute modules delivered online/via app. The workshop is delivered by a trained facilitator and involves interactive tasks to establish the need and context for subsequent engagement with the online/app-based resources. For example, this session considers the need for resilience in sport and other domains of life through videos, stories from elite athletes, and identifying challenges and obstacles that adolescents are likely to face. The adolescents are then provided with access to the supplementary modules to complete on their own. These resources are accessed through the Ahead of the Game website or by downloading the Ahead of the Game app.
Each module consists of instructional videos, stories from elite athletes and adolescents in sport, as well as reflective activities and exercises to try in their own game. These modules take approximately 10 minutes to complete, and address 6 topics in order: (1) problem-solving; (2) controlling the controllables; (3) managing your thoughts; (4) keeping your cool; (5) playing to your strengths; and (6) appreciating your team. Together, this program aims to provide adolescent males with skills and strategies for building resilience which can be applied to their own performance in sport (e.g., dealing with injury), as well as helping them cope with adversity in other domains of life (e.g., school, work).
3. The parents of adolescent males will be exposed to a brief (1 hour) mental health literacy program delivered face-to-face at a sporting club. Parents are the primary source of support for adolescents and the likely first observers of mental health disorder symptoms in their children. Therefore, parents need to be able to provide adequate support and assistance when their child or adolescent shows symptoms of a mental health disorder. Research, however, suggests that the mental health literacy of parents (in terms of their children’s mental health) is limited and parents are not adequately prepared or confident to assist children who experience a mental health disorder. The parent program is designed to increase parent mental health literacy through a one hour, face-to-face workshop delivered through community sport clubs. Specifically, the workshop aims to raise awareness of parents’ role in promoting and supporting positive adolescent mental health, and to increase knowledge of common youth mental health disorders, mentally healthy behaviours, and help-seeking options. It also aims to reduce stigma, promote constructive communication about mental health, and increase parental confidence and self-efficacy in supporting optimal adolescent mental health.
Intervention content is guided by the mental health literacy framework and is designed to be engaging through a mix of parent reflection, discussion, presentation, and videos. Materials were developed and adapted from Mental Health First Aid guidelines, or used with permission from mental health organisations and parenting organisations (e.g., ReachOut, Raising Children Network). The content of the intervention workshop has been assessed for relevance and accuracy by a Mental Health First Aid trainer. The workshop is kept intentionally brief to combat parents’ reported time constraints, and capitalises on the close social support networks among parents in the youth sport club environment. The information presented is set at an introductory level and is aided by the use of a powerpoint presentation. Specifically, the content includes: Awareness raising of the role of parents in adolescent mental health; how to recognise the signs of a mental health problem and how to tell the difference from normal teenage behaviour; professional help-seeking options; skills to start a conversation; positive preventative behaviours for adolescent mental health.
The program is delivered by one of two presenters who each have a Masters degree in Sport Psychology.
4. The coaches of adolescent male participants will be exposed to a coach training program which includes: two face-to-face workshops of 2 hours in duration; 2 mentoring sessions with a coach educator of 1 hour in duration; and 12 online modules of approximately 20 minutes in duration. This primary aim of the coach program is to help coaches develop the skills to facilitate intrinsic motivation among their players. Based on self-determination theory, the coach program is specifically targeted at helping coaches to support athletes’ autonomy, competence, and relatedness. The program involves a combination of face to face workshop and online materials. There are two face-to-face workshops which last 2 hours each. The workshops introduce the coaches to the online materials, where they begin working through activities and various video examples. In total, there are 12 online modules of approximately 20 minutes in duration each. Each module follows the same format: An introductory video about the principle being taught (approximately 2 minutes); Example videos of good and poor coaching practice relevant to the principle being taught (approximately 5 minutes); reflection on the good and poor practice videos (determined by the participant); and, goal setting relevant to the principle being taught (approximately 5 minutes). Workshops and online modules are supplemented by two 1-hour mentoring sessions, which take place either face-to-face or online via Skype (or similar application). Mentor sessions are coach-directed, but are usually used to answer questions that coaches have, explain principles in more detail if needed, and to provide ongoing support to the coach. The program is typically run as follows: Face to face workshop 1 (week 1); 6 online modules (weeks 2-5); mentoring session (week 6); face-to-face workshop 2 (week 7); 6 online modules (weeks 8-11); and a final mentoring session (week 12). All workshops and mentoring sessions are facilitated by a sports psychologist with a minimum of 2 years experience in the face-to-face delivery of interventions. Each facilitator received extensive (12 hours) training in the content and online system.
All participants will be drawn from organised sporting clubs in the Illawarra and Southern Sydney region of New South Wales, Australia. Given the bottom-up approach used within the trial, all participants are free to choose what programs they will attend. In total, the program is designed to last for up to 12 weeks, but the scheduling of programs is at the sporting club’s discretion.
Fidelity of program delivery is monitored via checklists which are completed by each presenter following each workshop. Fidelity to protocol of online components for the adolescent resilience program and the coach program are monitored by completion of the modules online or via the Ahead of the Game app. Parental and adolescent attendance at workshops is monitored by the facilitator.
Intervention code [1] 296397 0
Prevention
Comparator / control treatment
A non-randomised control group will be drawn from organised sporting clubs from a geographic location that has been matched to the intervention group at a community level (Central Coast region of New South Wales, Australia). This region was selected based on demographic characteristics of the community, availability of resources to collect data in the area, and the absence of ongoing research projects among sporting clubs in this region. The control group will receive usual care. In this instance, usual care will differ between each club in the control condition, but typically wouldn't include any explicit mental health or sport psychology programs.
Control group
Active

Outcomes
Primary outcome [1] 300187 0
Mental health literacy as measured by the Mental Health Literacy Scale total score and subscale scores.
Timepoint [1] 300187 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Primary outcome [2] 300188 0
Resilience as measured by the Connor-Davison Resilience Scale (CD-RISC 10) total score.
Timepoint [2] 300188 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [1] 329278 0
Psychological distress as measured by the Kessler-6 total score.
Timepoint [1] 329278 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [2] 329279 0
Wellbeing as measured by the Keyes' Mental Health Continuum (adolescent version) total score.
Timepoint [2] 329279 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [3] 329280 0
Help seeking intentions as measured by the General Help-Seeking Questionnaire
Timepoint [3] 329280 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [4] 329281 0
Confidence to help a peer, measured using a single item from the Mental Health Literacy Survey asking them to rate their confidence
Timepoint [4] 329281 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [5] 329282 0
Implicit beliefs regarding human traits measured by a 3-item questionnaire adapted specifically for this project
Timepoint [5] 329282 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [6] 329283 0
Parent mental health literacy as measured by the Mental Health Literacy Scale
Timepoint [6] 329283 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [7] 329284 0
Athlete engagement measured by 4 items from the Athlete Engagement Questionnaire
Timepoint [7] 329284 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [8] 329291 0
Athletes' perceived need support as measured by 3 items from Langen et al. 2015 (Langan, E., Blake, C., Toner, J., & Lonsdale, C. (2015). Testing the effects of a self-determination theory-based intervention with youth Gaelic football coaches on athlete motivation and burnout. Sport Psychologist)
Timepoint [8] 329291 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [9] 329292 0
Athletes' perceived coach controlling behaviours as measured by 4 items from the Controlling Coach Behaviour Scale
Timepoint [9] 329292 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [10] 329293 0
Athletes' perceived need satisfaction as measured by 5 items from the Basic Need Satisfaction in Sport Scale
Timepoint [10] 329293 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [11] 329294 0
Athlete motivation as measured by 5 items from the Behavioural Regulation in Sport Questionnaire
Timepoint [11] 329294 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [12] 329295 0
Athlete burnout as measured by 3 items from the Athlete Burnout Questionnaire
Timepoint [12] 329295 0
Baseline
Midpoint (approximately 3-5 weeks from baseline)
Post-intervention (approximately 12 weeks from baseline)
Secondary outcome [13] 329296 0
Awareness of messaging materials and key messages using a composite score of 3 items from a questionnaire designed for this study.
Timepoint [13] 329296 0
Baseline
Post-intervention (approximately 12 weeks from baseline)

Eligibility
Key inclusion criteria
Adolescent males who participate in organised sporting clubs and who are aged between 12 and 18 years.
Coaches are eligible if they are the primary or assistant coach of at least one adolescent male who meets eligibility criteria.
Parents or caregivers are eligible if they are the primary caregiver of at least one adolescent male who meets eligibility criteria.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non sport-participants
Those aged 11 years and under

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Using a bottom-up process, sporting clubs are able to choose which of the 5 programs they want to run for the participants in their club. As such, not all participants in the intervention group will receive all 5 programs.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on pilot data, we estimate an effect size of 0.15 on the primary outcome of mental health literacy. Using a desired power of 0.80, two groups, and two primary outcomes measures, the required sample size is 351 participants. Sample size calculations were undertaken in G*Power v3.1.
Between-group differences on the primary and secondary outcomes will be analysed according to intention-to-treat and per-protocol principles, using appropriate multivariable statistical analyses (linear mixed models, generalised linear models, adjusting for clustering at the club and team level, and covariates such as age and socioeconomic status).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/11/2016
Date of last participant enrolment
Anticipated
31/05/2017
Actual
30/06/2017
Date of last data collection
Anticipated
31/08/2017
Actual
30/09/2017
Sample size
Target
400
Accrual to date
Final
816
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14612 0
2522 - University Of Wollongong
Recruitment postcode(s) [2] 14613 0
2258 - Ourimbah

Funding & Sponsors
Funding source category [1] 294968 0
Charities/Societies/Foundations
Name [1] 294968 0
Movember Foundation
Country [1] 294968 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue, University of Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 294029 0
None
Name [1] 294029 0
Address [1] 294029 0
Country [1] 294029 0
Other collaborator category [1] 279375 0
University
Name [1] 279375 0
Australian Catholic University
Address [1] 279375 0
25A Barker Road Strathfield NSW 2135
Country [1] 279375 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296328 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 296328 0
Ethics committee country [1] 296328 0
Australia
Date submitted for ethics approval [1] 296328 0
21/10/2015
Approval date [1] 296328 0
18/12/2015
Ethics approval number [1] 296328 0
HE15/423

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

Contacts
Principal investigator
Name 70458 0
Dr Stewart Vella
Address 70458 0
Early Start Research Institute
University of Wollongong
Northfields Avenue
University of Wollongong, NSW, 2522
Country 70458 0
Australia
Phone 70458 0
+61 2 42215516
Fax 70458 0
Email 70458 0
[email protected]
Contact person for public queries
Name 70459 0
Vanessa O'Brien
Address 70459 0
Early Start Research Institute
University of Wollongong
Northfields Avenue
University of Wollongong, NSW, 2522
Country 70459 0
Australia
Phone 70459 0
+61 2 42215268
Fax 70459 0
Email 70459 0
[email protected]
Contact person for scientific queries
Name 70460 0
Stewart Vella
Address 70460 0
Early Start Research Institute
University of Wollongong
Northfields Avenue
University of Wollongong, NSW, 2522
Country 70460 0
Australia
Phone 70460 0
+61 2 42215516
Fax 70460 0
Email 70460 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2911Study protocolVella, S.A., Swann, C., Batterham, M., Boydell, K.M., Eckermann, S., Fogarty, A., Hurley, D.S., Liddle, S.K., Lonsdale, C., Miller, A., Noetel, M., Okely, A.D., Sanders, T., Telenta, J., Deane, F.P. (2018). Ahead of the Game Protocol: A multi-component, community sport-based program targeting prevention, promotion and early intervention for mental health among adolescent males. BMC Pubic Health, 18:390 https://doi.org/10.1186/s12889-018-5319-7  
2912Statistical analysis planVella, S.A., Swann, C., Batterham, M., Boydell, K.M., Eckermann, S., Fogarty, A., Hurley, D.S., Liddle, S.K., Lonsdale, C., Miller, A., Noetel, M., Okely, A.D., Sanders, T., Telenta, J., Deane, F.P. (2018). Ahead of the Game Protocol: A multi-component, community sport-based program targeting prevention, promotion and early intervention for mental health among adolescent males. BMC Pubic Health, 18:390 https://doi.org/10.1186/s12889-018-5319-7  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAhead of the game protocol: a multi-component, community sport-based program targeting prevention, promotion and early intervention for mental health among adolescent males.2018https://dx.doi.org/10.1186/s12889-018-5319-7
EmbaseMultiple effects health economic evaluation of the Ahead of The Game Study for mental health promotion in sporting club communities.2021https://dx.doi.org/10.1186/s13561-021-00323-1
N.B. These documents automatically identified may not have been verified by the study sponsor.