Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000886280
Ethics application status
Approved
Date submitted
21/05/2018
Date registered
25/05/2018
Date last updated
12/06/2019
Date data sharing statement initially provided
12/06/2019
Date results information initially provided
12/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A resilience program for adolescents in organised sport
Scientific title
Examining the effects of an internet-supported resilience intervention for adolescents in organised sport
Secondary ID [1] 294944 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study of ACTRN12617000709347

Health condition
Health condition(s) or problem(s) studied:
Resilience 307927 0
Mental health 307928 0
Wellbeing 307929 0
Condition category
Condition code
Mental Health 306964 306964 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents (aged 12-18) will be exposed to a brief (up to 1 hour) resilience workshop delivered face-to-face (e.g., at a sporting club), and supplemented by six online/mobile app modules - each of which take approximately 10-15 minutes to complete. The program aims to provide adolescents with mental skills for coping with adversity and building resilience through sport.

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 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 (www.aheadofthegame.org.au) or by downloading the Ahead of the Game app. The workshop aims to conclude by working through the first module (“problem-solving in sport”) to help the adolescents become familiar with the content and login process.

Each module consists of instructional videos, stories from athletes, as well as reflective activities and exercises to try on their own. These modules take approximately 10 minutes to complete, and address 6 topics in the following order: (1) “problem-solving in sport”; (2) “controlling the controllables”; (3) “how to manage your thoughts”; (4) “keeping your cool in sport”; (5) “playing to your strengths”; and (6) “appreciating your team”. Each module needs to be completed (in this order) before participants can begin the next. Participants are expected to complete the modules within two weeks.

Together, this program aims to provide adolescents with skills and strategies for building resilience which can be applied to their own participation in sport (e.g., dealing with injury), as well as helping them cope with adversity in other domains of life (e.g., school, work).

All participants will be drawn from organised sporting clubs in New South Wales, Australia. Fidelity of program delivery is monitored via checklists which are completed by the presenter following each workshop. Adolescent attendance at workshops is monitored by the facilitator. Fidelity to protocol of online components is monitored by completion of the modules online or via the Ahead of the Game app.
Intervention code [1] 301265 0
Prevention
Comparator / control treatment
A non-randomised control group was drawn from organised sporting clubs in a different geographic location in New South Wales, Australia. The intervention and control regions are Coffs Harbour and Lismore, and were selected based on demographic characteristics of the community, and availability of resources to collect data in the area. The control group will be a waitlist control, receiving usual care between data collection time points (i.e., baseline and follow-up 6 weeks after baseline), and then receiving the intervention after the second time point if positive effects are found.
Control group
Active

Outcomes
Primary outcome [1] 305953 0
Resilience as measured by the Connor-Davison Resilience Scale (CD-RISC 10) total score
Timepoint [1] 305953 0
Immediately pre-intervention, two weeks post-intervention (i.e., after completing the online/app-based modules), and follow-up (i.e., one month post-intervention - primary timepoint).
Secondary outcome [1] 347099 0
Psychological distress as measured by the Kessler-6 total score
Timepoint [1] 347099 0
Immediately pre-intervention, two weeks post-intervention (i.e., after completing the online/app-based modules), and follow-up (i.e., one month post-intervention).
Secondary outcome [2] 347100 0
Wellbeing as measured by the Keyes’ Mental Health Continuum (adolescent version) total score
Timepoint [2] 347100 0
Immediately pre-intervention, two weeks post-intervention (i.e., after completing the online/app-based modules), and follow-up (i.e., one month post-intervention).
Secondary outcome [3] 347101 0
Implicit beliefs regarding human traits (problem-solving ability) measured by a 3-item questionnaire adapted specifically for this project
Timepoint [3] 347101 0
Immediately pre-intervention, two weeks post-intervention (i.e., after completing the online/app-based modules), and follow-up (i.e., one month post-intervention).
Secondary outcome [4] 347103 0
Athlete engagement measured by 4 items from the Athlete Engagement Questionnaire
Timepoint [4] 347103 0
Immediately pre-intervention, two weeks post-intervention (i.e., after completing the online/app-based modules), and follow-up (i.e., one month post-intervention).
Secondary outcome [5] 347104 0
Athlete burnout as measured by 3 items from the Athlete Burnout Questionnaire
Timepoint [5] 347104 0
Immediately pre-intervention, two weeks post-intervention (i.e., after completing the online/app-based modules), and follow-up (i.e., one month post-intervention).

Eligibility
Key inclusion criteria
Adolescents who participate in organised sporting clubs and who are aged between 12 and 18 years.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who do not participate in sport through an organised club.
Individuals aged 11 or younger, and 19 or older.

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 design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous meta analyses (e.g., Leppin et al., 2014), we conservatively estimate an effect size of 0.2 on the primary outcome of resilience. Using a repeated measures ANOVA (within-between interaction), a desired power of 0.95, two groups, three time points, and a correlation among repeated measures of 0.4, the required sample size is 80 participants. Sample size calculations were undertaken in G*Power v3.1.

Within and between-group differences on the primary and secondary outcomes will be analysed in SPSS according to intention-to-treat and per-protocol principles, using appropriate multivariable statistical analyses (condition x time repeated measures analysis of variance, and covariates such as age and sex).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2018
Actual
27/06/2018
Date of last participant enrolment
Anticipated
23/07/2018
Actual
25/07/2018
Date of last data collection
Anticipated
3/09/2018
Actual
12/09/2018
Sample size
Target
120
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22727 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 26751 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 299529 0
Charities/Societies/Foundations
Name [1] 299529 0
Movember Foundation
Country [1] 299529 0
Australia
Primary sponsor type
Individual
Name
Dr Christian Swann
Address
School of Health and Human Sciences
Southern Cross University
Hogbin Drive
Coffs Harbour (M.G.45)
NSW 2450
Country
Australia
Secondary sponsor category [1] 298830 0
None
Name [1] 298830 0
Address [1] 298830 0
Country [1] 298830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300426 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 300426 0
Office of Research
Southern Cross University
PO Box 157
Lismore NSW 2480
Ethics committee country [1] 300426 0
Australia
Date submitted for ethics approval [1] 300426 0
23/04/2018
Approval date [1] 300426 0
11/05/2018
Ethics approval number [1] 300426 0
ECN-18-075
Ethics committee name [2] 300427 0
University of Wollongong/Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [2] 300427 0
University of Wollongong
Northfields Avenue
NSW 2522
Ethics committee country [2] 300427 0
Australia
Date submitted for ethics approval [2] 300427 0
21/10/2015
Approval date [2] 300427 0
18/12/2015
Ethics approval number [2] 300427 0
HE15/423

Summary
Brief summary
The primary aim of this project is to increase resilience among adolescents who participate in sport by delivering a face-to-face workshop supported by online/app-based resources. The secondary aims of this project are to (i) increase wellbeing, (ii) reduce psychological distress, (iii) reduce maladaptive implicit beliefs, (iv) reduce burnout, and (v) increase athlete engagement.
Trial website
www.aheadofthegame.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83630 0
Dr Christian Swann
Address 83630 0
School of Health and Human Sciences
Southern Cross University
Hogbin Drive
Coffs Harbour (M.G.45)
NSW 2450
Country 83630 0
Australia
Phone 83630 0
+61 2 6659 3032
Fax 83630 0
Email 83630 0
[email protected]
Contact person for public queries
Name 83631 0
Dr Christian Swann
Address 83631 0
School of Health and Human Sciences
Southern Cross University
Hogbin Drive
Coffs Harbour (M.G.45)
NSW 2450
Country 83631 0
Australia
Phone 83631 0
+61 2 6659 3032
Fax 83631 0
Email 83631 0
[email protected]
Contact person for scientific queries
Name 83632 0
Dr Christian Swann
Address 83632 0
School of Health and Human Sciences
Southern Cross University
Hogbin Drive
Coffs Harbour (M.G.45)
NSW 2450
Country 83632 0
Australia
Phone 83632 0
+61 2 6659 3032
Fax 83632 0
Email 83632 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
Individual participant data are not available for this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2171Ethical approval    375143-(Uploaded-24-05-2019-16-01-01)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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