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Trial registered on ANZCTR


Registration number
ACTRN12616001688471
Ethics application status
Approved
Date submitted
17/11/2016
Date registered
8/12/2016
Date last updated
10/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
a Coach based Motivation and Anti-Doping Education program (CoachMADE)
Scientific title
An intervention to assist coaches to optimize motivational climates and prevent current and future willingness to dope in adolescent sport: a cross-cultural project
Secondary ID [1] 290124 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CoachMADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
use of banned performance enhancing drugs (e.g., anabolic steroids) that have adverse health consequences. 300228 0
Condition category
Condition code
Public Health 300104 300104 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention period of the study will last 12 weeks. Coaches in the intervention arm in Australia will receive two group workshops (weeks 1 and 5; February/March 2017), each lasting 3 hours. Workshops will be delivered at a pre-arranged central location (e.g. Sport Club or Department of Sport and Recreation) or at Curtin University. Venues will be organised in advance to ensure suitability, and accessibility for attendees.
The workshops will be delivered by trained researchers with expertise in psychology and delivering interventions in sporting contexts. Individuals presenting the workshop will be trained using video recorded demonstration workshops, in-depth trainer notes and key slide notes.
The workshops will be delivered face to face using interactive presentation (PowerPoint, group discussions). In addition to standard anti-doping education topics, the intervention workshops will include content aimed to develop motivationally adaptive communication styles. Coaches will be provided with workshop packs (printed copies of slides, support materials and information to access online materials outside of the workshop).
In the intervention group the online material will include detailed descriptions of self-determination theory (SDT) based communication techniques and how they can be operationalised in the context of coach-athlete discussions about doping. To the extent that resources are available, we will also develop video material with examples of motivationally supportive and unsupportive communication. The study website and online material will be developed, designed and/or tailored specifically for this study. Online discussions/Q&A sessions will be organised based on participant availability and resource demand. The online website/discussions etc. are available as an additional resource for participants in he intervention group, and participation is not a compulsory component of the study.
Coaches in the intervention group will also be provided with online materials, activities and support during the 12 week intervention period. Online materials will be delivered through an online group (e.g. closed Facebook group, protected pages on the study website), and will include online group discussions/Q&A session led and directed by the research team. Handout material will support coaches in implementing what they learn in the workshops during their training sessions. Examples include scenarios of doping and communication techniques that coaches can use to talk to their athletes.
Intervention arm workshop – workshop outline
Workshop 1
understanding of ‘motivation’
Communication style in supporting or undermining athletes’ motivation
Applying motivation principles based on contemporary research
Principles to practice

Workshop 2
Anti-doping rules and practices
Applying motivational strategies to reduce athletes’ willingness to dope and risk of unintentional doping
Intervention fidelity will be assessed using filmed-observations between a selected number of coaches and an “athlete” in a roleplay scenario (e.g. coach-athlete conversation about the athlete considering use of a prohibited substance). The role of the “Athlete’s” will be undertaken by a trained researcher. Observations will be analysed and coding of the communication style used by the coach will be conducted. Researchers undertaking the “Athlete” role will be train in self-determination theory and concepts and to improve inter-rated reliability. The researchers ("Athlete") will be blinded to the experimental allocation of the coach.
Intervention code [1] 295874 0
Prevention
Intervention code [2] 296143 0
Lifestyle
Comparator / control treatment
The workshop will be delivered by trained researchers with expertise in psychology and delivering interventions in sporting contexts. Individuals presenting the workshop will be trained using video recorded demonstration workshops, in-depth trainer notes and key slide notes.
Eligible coaches assigned to the control arm will receive usual practice: a 90 minute group anti-doping education workshop. The workshop will be delivered face to face using interactive presentations (PowerPoint, group discussions) They will also be directed to available online materials including to WADA online educational program, and other anti-doping websites and resources to provide information about checking for prohibited substances, prohibited status of medication etc.

Coaches in the control arm will be offered an additional face-to-face motivation training workshop at the end of the study (after follow-up assessments). The motivation training will last for 3 hours, and will provide coaches with an understand of motivational and self-determination theory and how it can be applied in sporting context successfully.
The workshop will be delivered by trained researchers with expertise in psychology and delivering interventions in sporting contexts.

Workshops will be delivered at a pre-arranged central location (e.g. Sport Club or Department of Sport and Recreation) or at Curtin University. Venues will be organised in advance to ensure suitability, and accessibility for attendees.

Control arm workshop – Session outline
Doping and anti-doping governance
Athlete Support Personnel’s rights and responsibilities
Anti-doping rule violations
WADA/WADC
ADRVs for athletes and ASP
Substances and methods on the Prohibited list
Checking medications & TUEs
Consequences of doping, including sanctions, health and social consequence
Doping Control procedure

Notes:
Control condition based on current practice in the anti-doping field. Underpinned by WAD Code (Article 18 below).

ARTICLE 18 EDUCATION
18.1 Basic Principle and Primary Goal
The basic principle for information and education programs for doping-free sport is to preserve the spirit of sport, as described in the introduction to the Code, from being undermined by doping. The primary goal of such programs is prevention. The objective shall be to prevent the intentional or unintentional use by athletes of Prohibited Substances and Prohibited Methods.
Information programs should focus on providing basic information to athletes as described in Article 18.2. Education programs should focus on prevention. Prevention programs should be values based and directed towards athletes and athlete Support Personnel with a particular focus on young people through implementation in school curricula.
All Signatories shall within their means and scope of responsibility and in cooperation with each other, plan, implement, evaluate and monitor information, education, and prevention programs for doping-free sport.
18.2 Programs and Activities
These programs shall provide athletes and other Persons with updated and accurate information on at least the following issues:
1. Substances and methods on the Prohibited list; 2. Anti-doping rule violations; 3. Consequences of doping, including sanctions, health and social consequences; 4. Doping Control procedures.
Control group
Active

Outcomes
Primary outcome [1] 299869 0
Assess athletes’ willingness to take potentially prohibited substances. This will be assessed with a new measure developed by the research team (based on work by Lucidi et al., 2014).
Timepoint [1] 299869 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [1] 328343 0
Moral disengagement for athletes and coaches. Assessment will be conducted using a validated scale (Moral disengagement in doping scale, Kavussanu et al. 2016).
Timepoint [1] 328343 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [2] 329150 0
Athlete attitudes and efficacy to resist doping-related temptations. Assessment will be conducted using a validated scale (Barkoukis, et al. 2013)
Timepoint [2] 329150 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [3] 329152 0
Change in perceived coach behaviours,. Assessment will be conducted using validated (modified) scales (Interpersonal Behaviors Questionnaire (IBQ) in Sport, Rocchi, Pelletier and Desmarais. 2016 and Perceived Motivational Climate in Sport Questionnaire-2, Newton et al., 2000)
Timepoint [3] 329152 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [4] 329153 0
Change in athlete satisfaction and frustration of psychological needs Assessment will be conducted using a validated scale (Basic Need Satisfaction and frustration Scale, Chen et al., 2015)
Timepoint [4] 329153 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [5] 329206 0
Change in athlete use of performance/recreational substances and drugs. This will be assessed with a new measure developed by the research team
Timepoint [5] 329206 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [6] 329454 0
Change in coach confidence to create anti-doping atmosphere within the team. This will be assessed with a new measure developed by the research team.
Timepoint [6] 329454 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [7] 329455 0
Change in coach efficacy to foster anti-doping attitudes. This will be assessed with a new measure developed by the research team (scale will be be tested for validation prior to use in the project).
Timepoint [7] 329455 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [8] 329891 0
Coach efficacy to confront athletes regarding doping. Assessment will be conducted using selected items from validated (modified) psychological scale (Doping Confrontation efficacy Scale, Sullivan et al., 2015)
Timepoint [8] 329891 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.
Secondary outcome [9] 329892 0
Coach confidence to deliver anti-doping education. This will be assessed with a new measure developed by the research team. This new scale will be be tested for validation prior to use in the project.
Timepoint [9] 329892 0
Baseline (0 week) and at 12 week and 20 week after commencement of the intervention.

Eligibility
Key inclusion criteria
Eligible coaches:
full-time or part-time with at least 5 years coaching experience and with varying levels of seniority.
Coaching in individual and/or team sports, with a record of doping risk (for example rugby, cycling, weightlifting, football and swimming).
Coach athletes aged 14-18 years, who train at least once a week and compete regularly during the competition season.

Eligible athletes:
Trained by a coach who has enrolled onto the study
Aged 14-18 years
Train at least once a week and compete regularly during the competition season.
Minimum age
14 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Coaches:
Apprentice coaches
Coach less than 6 athletes
No more than 6 coaches will be recruited from any given club,

Athletes
Athletes under 14 years
Athletes over 18 years
Athletes where consent is withdrawn by a parent/guardian (passive consent)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

This will occur after consent to participate is obtained and baseline assessments have been carried out, The coaches will be stratified by sport, athlete age/experience and geography, and will be randomly assigned to two groups by a research associate using a computerised random number generator.

In this way the principal researchers are blinded to group allocation. It is not possible to blind the researchers delivering the programs, or the coaches, to group allocation, but they will be blinded to the primary aims of the study.

Coaches within a single club, as well as from geographically nearby clubs, will be allocated to the same arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power estimates were calculated with the Optimal Design Software (Raudenbush, et al., 2011) for clustered RCTs with treatment at level 2, primary outcomes at level 1, repeated measures, estimates of moderate effect, and oversampling by about 30% to counter possible missing values and coach/athlete dropout from the study.

Descriptive statistical analysis will be used to report on coach and athlete recruitment, acceptability of the intervention (coaches), and rates of adherence and dropout. Questionnaire and observation (interviews and video-recording) data will be analysed using multi-level growth modelling (mixed linear modelling) to examine how within-person changes in coaches perceptions of their own instructional style predict within-person changes in their athletes perceptions of the coaches instructional style and willingness towards doping attitudes and behaviours. We will also implement: 1) a process evaluation of the intervention, via coach interviews, coach questionnaires on ease and usefulness of the training material, and 2) fidelity to the protocol assessments, via coach observations (audio or video-recording).

Coach N=120, expected to generate athlete N = 720-1200

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 14479 0
6000 - Perth
Recruitment postcode(s) [2] 14480 0
6102 - Bentley
Recruitment outside Australia
Country [1] 8310 0
United Kingdom
State/province [1] 8310 0
Leeds
Country [2] 8313 0
Greece
State/province [2] 8313 0
Thessaloniki

Funding & Sponsors
Funding source category [1] 294553 0
Other
Name [1] 294553 0
International Olympic Committee
Address [1] 294553 0
International Olympic Committee, POBox 356, 1007 LAUSANNE, SWITZERLAND
Country [1] 294553 0
Switzerland
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987, Perth
Western Australia, 6845
Country
Australia
Secondary sponsor category [1] 293423 0
None
Name [1] 293423 0
Address [1] 293423 0
Country [1] 293423 0
Other collaborator category [1] 279231 0
University
Name [1] 279231 0
Leeds Beckett University
Address [1] 279231 0
Leeds Beckett University
Leeds
LS1 3HE
United Kingdom
Country [1] 279231 0
United Kingdom
Other collaborator category [2] 279232 0
University
Name [2] 279232 0
Aristotle University of Thessaloniki University
Address [2] 279232 0
Aristotle University of Thessaloniki
University Campus
54124 Thessaloniki
Greece
Country [2] 279232 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296125 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 296125 0
Kent Street, Bentley, Perth
Western Australia, 6102
Ethics committee country [1] 296125 0
Australia
Date submitted for ethics approval [1] 296125 0
Approval date [1] 296125 0
03/10/2016
Ethics approval number [1] 296125 0
HRE2016-0345

Summary
Brief summary
Aim and hypothesis: This project aims to support the principles and aims of the Olympic Charter by developing and testing a preventative motivation theory informed and evidence-based intervention.

Methods: The intervention will deliver anti-doping education and psychological training to support coaches’ in communicating with athletes in a needs supportive manner. The intervention will be compared against ‘usual practice’ (i.e., education programs run by National Anti-Doping Organizations).

This is a multi-centre research project with sites in Western Australia, the UK, and Greece. The project is a cluster randomised control trial (2 arms; total across 3 countries: 60 coaches and 600 athletes in each arm). Athletes will be asked to complete a questionnaire package of psychological measures. The constructs of the questionnaire will include rating their willingness to take prohibited performance enhancing substances, their anti-doping attitudes, efficacy to resist doping-related temptations, and perceptions of coach behaviours. Similarly coaches will be asked to complete a separate package of psychological constructs and measures. The measures will ask coaches to rate their efficacy to foster anti-doping attitudes and deliver anti-doping information, and their efficacy to confront athletes about doping.

Data collection and analysis: Baseline data (0 week) (video-recording of coaches, athlete/coach questionnaire packages) will be collected prior to the first workshop (control/intervention). Questionnaire packages will be repeated at the end of the intervention (12 week) and again at a follow-up (20 week). Interviews with coaches in the intervention arm will take place after the second workshop. We will use advanced statistical analysis (multilevel growth models) to account for both the longitudinal and nested (athletes within coaches) nature of the data. We will implement: 1) a process evaluation of the intervention, via coach interviews, coach questionnaires on ease and usefulness of the training material, and 2) fidelity to the protocol assessments, via coach observations, and 3) we will analyse the data and disseminate the results of the intervention via coach information sessions, printed material, policy briefings, media interviews, and social media engagement.
Trial website
www.coachMADE.com
Trial related presentations / publications
Public notes
Attachments [1] 1166 1166 0 0

Contacts
Principal investigator
Name 68918 0
Prof Nikos Ntoumanis
Address 68918 0
Curtin University, Kent Street, Bentley, Perth
Western Australia, 6102
Country 68918 0
Australia
Phone 68918 0
+61892663297
Fax 68918 0
Email 68918 0
nikos.ntoumanis@curtin.edu.au
Contact person for public queries
Name 68919 0
Mr Brendan Smith
Address 68919 0
Curtin University, Kent Street, Bentley, Perth
Western Australia, 6102
Country 68919 0
Australia
Phone 68919 0
+61892662144
Fax 68919 0
Email 68919 0
brendan.smith@curtin.edu.au
Contact person for scientific queries
Name 68920 0
Mr Brendan Smith
Address 68920 0
Curtin University, Kent Street, Bentley, Perth
Western Australia, 6102
Country 68920 0
Australia
Phone 68920 0
+61892662144
Fax 68920 0
Email 68920 0
brendan.smith@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary