Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001378819
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
11/10/2021
Date last updated
15/02/2022
Date data sharing statement initially provided
11/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Mental health and resilience in organised sport: The Ahead of the Game program
Scientific title
A cluster-randomised controlled trial of Ahead of the Game: An intervention to promote mental health help-seeking and resilience
Secondary ID [1] 304942 0
MRF1199972
Universal Trial Number (UTN)
Trial acronym
AOTG RCT
Linked study record
The current study is a follow-up to ACTRN12617000709347

Health condition
Health condition(s) or problem(s) studied:
Mental Health Literacy 323172 0
Resilience 323173 0
Mental Health 323174 0
Condition category
Condition code
Mental Health 320757 320757 0 0
Anxiety
Mental Health 320758 320758 0 0
Depression
Mental Health 320759 320759 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the intervention group (which include adolescent males, their parents, and their coaches) will be exposed to at least one workshop from a possible four which will be determined by their sporting club.

Adolescents will be exposed to:
1. Your Path to Success in Sport (YPTSS): This workshop targets key psychological skills identified in sport-based resilience literature and aims to help adolescent males cope with adversity through explicit sport-based examples. This component will be delivered via a brief, team-based, face-to-face workshop (approx. 45 min) supported by six internet-based (website/mobile application) modules lasting approximately 15 minutes each. The workshop is framed around expectations versus reality in the process of achieving one‘s goals to identify inevitable adversities that adolescents are likely to face in and outside of sport. The workshop also allows participants to sign up for the internet-based modules during the workshop, and to complete the first module within the session, to enhance subsequent uptake and engagement. All workshops will be delivered by a trained member of the research team (including Mental Health First Aid training) in a changing room or clubhouse of the participants sporting club, or if this is unavailable, at a central location (such as the University of Wollongong). Adolescents are then free to undertake the internet-based modules at home in their own time using the aheadofthegame.org.au website. The internet-based modules address: (i) problem solving; (ii) controlling the controllables; (iii) managing your thoughts; (iv) keeping your cool; (v) playing to your strengths; and (vi) appreciating your team. The six online YPTSS modules include a combination of short videos, written information, and a number of open-ended response questions which encourage the participant to reflect and apply the strategies discussed to their own life. Following the YPTSS workshop, it is anticipated that the participants will complete the six online modules before the following Help Out a Mate (HOAM) workshop (discussed below), however, completing the six online modules for YPTSS is optional, and not a requirement to take part in the HOAM workshop.

2. Help Out a Mate: Adolescents will be invited to take part in a brief team-based, face-to-face mental health literacy workshop. The HOAM workshop will usually be delivered after a routine scheduled practice and takes approximately 45 minutes. Workshops will be delivered in a changing room or clubhouse of the participating club, or if not available, a central location (e.g., University of Wollongong). Specifically, the workshop involves the following components; (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 workshop 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, this workshop addresses the issue of how to ask for help if an adolescent feels that he needs it, specifically through the use of role-plays scenarios for participants to practice providing and asking for help. Additional resources provided to adolescents include a business card that lists key steps on how to help a friend [Ask, Listen, Encourage, Check Back In), and a boot bag to hold sports shoes and drink bottle with Ahead of the Game branding. All workshops will be delivered by a member of the research team with Mental Health First Aid training and previous training in the delivery of the HOAM workshop.

Parents will be exposed to:
3. Number 1 Supporter: The parents of the adolescent males will be exposed to the Number 1 Supporter workshop, which is designed to increase parent mental health literacy regarding adolescent mental health via a one-hour, face-to-face workshop. Specifically, the workshop aims to raise parents‘ awareness of their role in promoting and supporting positive adolescent mental health, and to increase knowledge of common adolescent mental health disorders, positive mental health-promoting behaviours, and help-seeking options. This workshop also aims to reduce stigma, promote constructive communication about mental health, and increase parental confidence to support adolescent mental health. The parent component is also delivered at a team level, but can also be delivered at a club level (i.e., parents from multiple teams in each club attending the same session). All workshops will be delivered by a member of the research team (with Mental Health First Aid training) at the sports club where facilities allow us to do so, or at a central location (e.g., University of Wollongong). A pamphlet is also provided to parents during the workshop that summarises the workshop content. The workshop 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, and 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.

Coaches will be exposed to:
4. Got Your Back: Coaches of male adolescents will be exposed to the Got Your Back workshop, which is designed to increase coach mental health literacy regarding adolescent mental health via a 75 minute, face-to-face workshop. The workshop content focuses on: (i) what is mental health?; (ii) myths about mental health and mental illness; (iii) what is anxiety?; (iv) what is depression?; (v) how to help an athlete; and (vi) creating an environment to promote mental health. In exploring this content, this workshop aims to discuss coaches‘ perceptions of their role in promoting and supporting positive adolescent mental health, to increase knowledge of common adolescent mental health disorders, positive mental health-promoting behaviours, and help-seeking options. This workshop also aims to reduce stigma, promote constructive communication about mental health, and increase coaches’ confidence to support adolescent mental health. Given a wide variation in coaches’ perceptions of their role in adolescent mental health, the workshop takes a discussion-based approach. The coach component can be delivered at a team level, but our preference is to deliver at a club level due to low numbers of coaches within a single team (i.e., coaches from multiple teams in each club attending the same session). All workshops will be delivered by a member of the research team [as above, with Mental Health First Aid training] at the sports club where facilities allow us to do so, or at a central location (e.g., University of Wollongong).

All programs (parents, coaches, adolescents) will be presented following adolescent baseline data collection. Regarding adolescents, YPTSS will always be presented before HOAM. Ideally, HOAM will take place 1 week after YPTSS, although this may take up to 4 weeks depending on the individual team’s availability. The parents and coach programs will take place in parallel with these adolescent programs, although the specifics of when each of these programs takes place (i.e., same time as YPTSS session, in between YPTSS and HOAM etc.) will depend on the club and their resources. We estimate all programs will be delivered between 2 and 6 weeks following adolescent baseline.

In addition to the above workshops, all participating clubs will receive promotional banners and posters which can be displayed at their clubhouse, changing rooms, and surrounding areas. These materials will be distributed after baseline data collection. The banners and posters provide brief messages to promote mental health literacy and help-seeking, in a manner consistent with the Ahead of the Game branding and workshop materials. For example, banners specify steps for improving mental fitness (e.g., keeping active, taking time to relax, eating healthily) and steps for helping out your teammates (Ask how your mates are doing, listen to what they say, explore the options they might have, and keep in touch with where they’re at). Further, following baseline data collection, adolescent participants will receive a drink bottle and boot bag to hold sports shoes/equipment with Ahead of the Game branding.

All participants will be drawn from organised sporting clubs in the Illawarra, South Coast and Greater Sydney regions of New South Wales, Australia. The fidelity of the program delivery is measured via checklists which are completed by each presenter following each workshop. Further, workshop participants are asked to rate the facilitation of the workshop. Fidelity to the protocol of online components for the adolescent resilience program are monitored by completion of the modules online or via the Ahead of the Game app. Parental, coach, and adolescent attendance at workshops is monitored by the facilitator.
Intervention code [1] 321401 0
Prevention
Comparator / control treatment
Clubs assigned to the active control group will receive promotional banners and posters after baseline data collection. These banners and posters can be displayed within a clubhouse, changing rooms, and surrounding areas. The banners and posters provide brief messages to promote mental health literacy and help-seeking, in a manner consistent with the Ahead of the Game branding. Following baseline data collection, adolescents in the active control group will also receive a drink bottle and boot bag to hold sports shoes/equipment with Ahead of the Game branding.
Control group
Active

Outcomes
Primary outcome [1] 328567 0
For adolescents: Intentions to Seek Help from formal sources (as measured by the General Help-Seeking Questionnaire)
Timepoint [1] 328567 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Primary outcome [2] 328568 0
For adolescents: Resilience (as measured by the Connor-Davison Resilience Scale)
Timepoint [2] 328568 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Primary outcome [3] 328569 0
For parents and coaches: Intentions to provide help (as measured by intentions to provide help scale developed specifically for this study, which comprises 3-items for parents and 4-items for coaches)
Timepoint [3] 328569 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [1] 399447 0
For adolescents: Intentions to provide help (measured by a single item developed and used in the previous Ahead of the Game controlled trial; ACTRN12617000709347)
Timepoint [1] 399447 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [2] 399448 0
For adolescents, parents, and coaches: Psychological distress (as measured by the Kessler 6, reverse scored)
Timepoint [2] 399448 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [3] 399449 0
For adolescents: Quality of life (as measured by the Child Health Utility Scale)
Timepoint [3] 399449 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [4] 399450 0
For adolescents: Social Distance (as measured by the Social Distance Scale)
Timepoint [4] 399450 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [5] 399452 0
For adolescents, parents, and coaches: Service use for mental health (as measured by the Health Service Use Questionnaire)
Timepoint [5] 399452 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [6] 399453 0
For adolescents, parents, and coaches: Conceptualisations of mental health (as measured by the Continuum with Normal subscale of the Belief about Illness scale)
Timepoint [6] 399453 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [7] 399454 0
For adolescents: Confidence to provide help (as measured by a single item designed specifically for this study)
Timepoint [7] 399454 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [8] 399455 0
For adolescents, parents, and coaches: Social Identity (as measured by the Social Identity Questionnaire for Sport)
Timepoint [8] 399455 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [9] 401475 0
For adolescents, parents, and coaches: Anxiety Literacy (Anxiety Literacy Questionnaire)
Timepoint [9] 401475 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [10] 401476 0
For adolescents, parents, and coaches: Depression Literacy (Depression Literacy Questionnaire)
Timepoint [10] 401476 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [11] 401477 0
For parents and coaches: Intentions to Seek Help with a Child (as measured by an adapted version of the General Help-Seeking Questionnaire)
Timepoint [11] 401477 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [12] 401478 0
For adolescents, parents, and coaches: Self-Stigma of Seeking Help (as measured by the Self-Stigma of Seeking Help Scale)
Timepoint [12] 401478 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [13] 401479 0
For adolescents, parents, and coaches: Stigmatising Stereotypes (as measured by Dangerous/Unpredictability Scale)
Timepoint [13] 401479 0
Baseline
Post-intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [14] 401480 0
For adolescents, parents, and coaches: Cost-effectiveness (as measured by resource cost in dollars per participant to complete program)
Timepoint [14] 401480 0
Post-intervention (i.e., following completion in the program)
Secondary outcome [15] 406320 0
For parents and coaches: Intentions to Seek Help from formal sources (as measured by the General Help-Seeking Questionnaire)
Timepoint [15] 406320 0
Baseline
Post-Intervention (approximately 2-6 weeks from baseline)
Follow Up (approximately 6 months from baseline)
Secondary outcome [16] 406321 0
For adolescents, parents, and coaches: Informational Material Awareness (as measured by three items developed for this study)
Timepoint [16] 406321 0
Post-intervention (approximately 2-6 weeks from baseline)
Secondary outcome [17] 406322 0
For adolescents, parents, and coaches within the intervention group: Workshop Facilitator Ratings (as measured by nine items developed for this study)
Timepoint [17] 406322 0
Post-Intervention (2-6 weeks from baseline)

Eligibility
Key inclusion criteria
Adolescent males who participate in organised sporting clubs and who are aged between 12 and 20 years, their parents, and their coaches are eligible for participation.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Non sport-participants
2) Female sport participants (adolescent)
3) Sporting clubs with recent history critical incidents (e.g., death by suicide within the club). In such instances, the proposed research program may not be appropriate, and an alternative program would be recommended to the club that may be more suitable.

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)
Randomisation will take place at a club level. That is, after agreeing to a participate, a club will be randomised to receive either: (1) workshops and promotional materials; or (2) just promotional materials.

Allocation to either of these conditions will take place using sequentially number, sealed opaque envelopes. These envelopes will be created (following sequence generation - see below) by a member of the research team who is not involved in recruiting sporting clubs, and further, stored in a locked cabinet which can only be accessed by members of the research team who are not directly involved in recruiting clubs. The recruited clubs name will be written on the front of the envelope before opening the envelope, with this envelope then kept for the purposes of an audit trail.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by sporting type. This is to ensure that the two conditions are relatively balanced between clubs within different sports, as different sports may have different contextual factors which may impact delivery (i.e., team vs. individual sports).

Given that there is likely to be a relatively low sample (as randomisation occurs at a club, rather than team or participation, level), a blocked randomisation approach will be used. However, the size and order of these blocks will be determined by a research team member who is not involved in the process of recruiting clubs. These sequences will then be provided to the research team member responsible for creating the sealed, opaque envelopes. A different sequence will be generated for each sport type in which recruitment may occur (as randomisation will be stratified by sport type). Whilst general instruction will be provided to the research team member responsible for generating this sequence (i.e., most blocks should be small, such as blocks of 2, 4, or 6), the order, and amount, of these different block sizes will be determined by this research team member, and only discussed with the chief investigator (who will not be directly involved in recruiting). Accordingly, those responsible for recruiting will not be aware of the sequence, and hence, unable to predict allocation of conditions.
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
To calculate the required sample size we have used the primary outcome variable of intentions to seek help from formal sources as measured by the General Help Seeking Questionnaire. We used the data from the previous controlled trial of the Ahead of the Game program (ACTRN12617000709347) to calculate the effect size, and design effect. Based on the previous trial, we estimate a mean number of athletes per team of 8.53 (SD = 6.21) and an intra-class correlation co-efficient of 0.025. This yields a coefficient of variation (CV) of 0.7285. Taken together, these values yield a design effect of 1.3264. This means that the sample size needs to be inflated by this factor to account for clustering at a team level. The effect size for the primary outcome in the previous study was 0.26. We have used 0.25 in our calculations for this study, along with an alpha value of .05 and 80% power. The observed pre/post correlation on the primary outcome measure was 0.48, so we have used a value of 0.5 here. Finally, the retention rate was 65% in the previous trial, so we are allowing for 35% dropout from the current study.
Based on the above assumptions, a raw n per group is 253 participants, and a total 506 participants across the two groups. To allow for 35% dropout, the required sample size would be 389 participants per group. To adjust for the effect of clustering at the team level, the final sample required is 516 per group, and 1032 participants in total.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
6/12/2021
Date of last participant enrolment
Anticipated
1/03/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
1032
Accrual to date
33
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309330 0
Government body
Name [1] 309330 0
Australian Department of Health; Medical Research Future Fund
Country [1] 309330 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue, University of Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 310297 0
University
Name [1] 310297 0
University of Melbourne
Address [1] 310297 0
Grattan Street, Parkville, Victoria, 3010
Country [1] 310297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309150 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 309150 0
Ethics committee country [1] 309150 0
Australia
Date submitted for ethics approval [1] 309150 0
16/05/2021
Approval date [1] 309150 0
09/07/2021
Ethics approval number [1] 309150 0
2021/207

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

Contacts
Principal investigator
Name 113158 0
Dr Stewart Vella
Address 113158 0
School of Psychology
University of Wollongong
Northfields Avenue
University of Wollongong, NSW, 2522
Country 113158 0
Australia
Phone 113158 0
+61 2 42215516
Fax 113158 0
Email 113158 0
[email protected]
Contact person for public queries
Name 113159 0
Matthew Schweickle
Address 113159 0
School of Psychology
University of Wollongong
Northfields Avenue
University of Wollongong, NSW, 2522
Country 113159 0
Australia
Phone 113159 0
+61 2 4221 3677
Fax 113159 0
Email 113159 0
[email protected]
Contact person for scientific queries
Name 113160 0
Matthew Schweickle
Address 113160 0
School of Psychology
University of Wollongong
Northfields Avenue
University of Wollongong, NSW, 2522
Country 113160 0
Australia
Phone 113160 0
+61 2 4221 3677
Fax 113160 0
Email 113160 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
12811Study protocol  [email protected]
12812Statistical analysis plan  [email protected]



Results publications and other study-related documents

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