Doping in SportNCT04203992
Videogame for the Prevention of Doping and Supplement Abuse in Teenage Athletes
A study testing Videogame in people with Doping in Sport and Performance Enhancing Product Use, run by McGill University.
Trial summary
The purpose of this research is to test the effectiveness of an interactive doping education videogame among student athletes. Specifically, the game will teach athletes aged 13-16 years about the risks of doping and will foster the values, motivation, and behavioural skills needed to avoid temptation and pressure to… Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Doping in Sport, Performance Enhancing Product Use
- What is being tested?
- Videogame
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject competes in a competitive sport at the high school level or higher
- Able to read and understand English
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TRUE CHAMPION: An Educational Videogame Intervention for the Prevention of Doping and Supplement Abuse in Teenage Athletes
The purpose of this research is to test the effectiveness of an interactive doping education videogame among student athletes. Specifically, the game will teach athletes aged 13-16 years about the risks of doping and will foster the values, motivation, and behavioural skills needed to avoid temptation and pressure to dope. The investigators hypothesize that student athletes who play the intervention game will have lower use of banned substances and sport supplements, greater intentions to stay clean, and will also show improvements in the cognitive and motivational antecedents to doping when compared to a control condition.
Read the detailed description
284 student athletes will be enrolled in this two-arm quasi-experimental study. The participants will be boys and girls, aged 13 to 16 years who compete in any sport. Participants will be recruited and enrolled through partnerships with their school physical education and/or sport programs. Participants will complete baseline questionnaires assessing demographics, history of sport participation, and psychological variables related to doping prevention including knowledge, doping self-regulatory efficacy, motivation, attitudes, intentions, perceived norms, doping refusal, substance use behaviours, and doping related protective behaviours (e.g., checking the list of ingredients on medications). Participants will then be assigned to either an intervention group (n = 142; the doping videogame the investigators are developing) or a comparison group (n = 142). The comparison group will be given printed educational materials about doping education, developed by an accredited source (e.g., UNESCO). Assignment to the intervention or comparison group will be conducted at the level of the school to reduce the potential for contamination that could occur if intervention and comparison students were interacting in their school environment and sharing information they learned from the game. Participants from the intervention group will play five, 60-minute sessions over the course of one month (5 hours of total gameplay). Before the gameplay sessions begin, the Project Director and research assistants will orient the intervention group participants to the use of the intervention videogame. Players will be given a tutorial on an iPad demonstrating the mechanics of the game and how to use the iPad. Each player will have their own dedicated iPad that they will use during each game play session (this will be provided by the research team). Shortly after the last gameplay session is completed, participants from both groups will be asked to complete a questionnaire assessing the same psychological variables assessed at baseline as well as their gameplay experience. The psychological variables will also be assessed at three, six, and 12 month follow-ups.
- Conditions
- Doping in Sport, Performance Enhancing Product Use
- Being tested
- Videogame, Control
- Keywords
- Student athletes, Supplements, Videogame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideogameBehavioural
True Champion is an educational, values-based game that aims to empower young athletes to make informed decisions to avoid doping.
Participants engaging in the videogame sessions will encounter a series of thought-provoking situations and knowledge tests. Players will help their assigned character navigate through these curriculum-rich scenarios in order to reach their performance goals in a healthy and ethical way.
ControlBehavioural
Participants will be given an anti-doping booklet prepared by UNESCO. This booklet is considered standard educational material, i.e. what might be presented to young athletes as part of their regular sports curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Videogame | Experimental | Educational videogame, five 60-minute sessions over one month Receives: Behavioral: Videogame |
| Booklet | Active comparator | Educational booklet, one session Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of banned substances
Self-reported use of banned substances for performance enhancement or recovery in sport.
This outcome will be measured using a self-reported questionnaire.
Scale: Performance-Enhancing Substances and Methods Use
Minimum value: 1 - extremely unlikely (better outcome)
Maximum value: 7 - extremely likely (worse outcome)
Measured: 12 months
Use of sport supplements
Self-reported use of supplements for performance enhancement or recovery in sport.
This outcome will be measured using a self-reported questionnaire.
Scale: Performance-Enhancing Substances and Methods Use
Minimum value: 1 - extremely unlikely (better outcome)
Maximum value: 7 - extremely likely (worse outcome)
Measured: 12 months
Intentions to use banned substances and sport supplements
Self-reported intentions of using banned substances or supplements for performance enhancement or recovery in sport.
This outcome will be measured using a self-reported questionnaire.
Scale: Performance-Enhancing Substances and Methods Use
Minimum value: 1 - extremely unlikely (better outcome)
Maximum value: 7 - extremely likely (worse outcome)
Measured: 12 months
Secondary outcomes (7)
Knowledge
Knowledge of anti-doping rules, definitions and consequences of doping.
This outcome will be assessed using a True/False questionnaire.
Measured: 12 months
Doping Self-Regulatory Efficacy
Self-efficacy for refusing doping under a variety of pressure situations.
This outcome will be measured using a validated questionnaire.
Scale: Doping Self-Regulatory Efficacy
Minimum value: 1 - no confidence (better outcome)
Maximum value: 5 - complete confidence (worse outcome)
Measured: 12 months
Motivation
Motivations for abstaining from doping.
This outcome will be measured using an adaptation of a validated questionnaire.
Scale: Treatment Self-Regulation Questionnaire for the Avoidance of Doping in Sport
Minimum value: 1 - not true at all (worse outcome)
Maximum value: 7 - very true (better outcome)
Measured: 12 months
Attitudes
Attitudes towards doping in sport.
This outcome will be measured using a subscale from a validated questionnaire.
Scale: The Adolescent Sport Doping Inventory
Minimum value: 1 - strongly disagree (worse outcome)
Maximum value: 7 - strongly agree (better outcome)
Note: some items are reverse-scored
Measured: 12 months
Anti-doping protective behaviours
Self-reported engagement in behaviours linked to doping abstinence.
Scale: Microbehaviours
Minimum value: 1 - never (worse outcome)
Maximum value: 7 - always (better outcome)
Measured: 12 months
Doping refusal
Self-report of having refused a supplement or performance-enhancing substance.
This outcome will be assessed using a Yes (worse outcome) or No (better outcome) questionnaire.
Measured: 12 months
Gameplay experience
Enjoyment and acceptability of the True Champion videogame among players assigned to the intervention condition.
This outcome will be assessed using a questionnaire we have created. Answers will range from "strongly disagree" to "strongly agree".
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study startNov 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Doping in SportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We aim to enroll 284 male and female student-athletes between the ages of 13 and 16. Participants will be assigned to either an intervention group (n = 142) or a comparison group (n = 142).
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- International Olympic Committee, World Anti-Doping Agency, Phantom Compass, Digitalmill, Inc.
- Responsible party
- Principal investigator, Lindsay Duncan, McGill University
- Investigators
- Lindsay R Duncan, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203992
- Sponsor's protocol ID
- 476-0418
- Status last verified
- Sep 2020
- First submitted
- 11 Dec 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goulet C, Valois P, Buist A, Cote M. Predictors of the use of performance-enhancing substances by young athletes. Clin J Sport Med. 2010 Jul;20(4):243-8. doi: 10.1097/JSM.0b013e3181e0b935.
PubMed 20606508Boardley I, Smith AL, Mills JP, Grix J, Wynne C., & Wilkins L. Development of Moral Disengagement and Self-Regulatory Efficacy Assessments Relevant to Doping in Sport and Exercise. SportRxiv, 12 Oct. 2017. Web.
Chan DK, Dimmock JA, Donovan RJ, Hardcastle S, Lentillon-Kaestner V, Hagger MS. Self-determined motivation in sport predicts anti-doping motivation and intention: a perspective from the trans-contextual model. J Sci Med Sport. 2015 May;18(3):315-22. doi: 10.1016/j.jsams.2014.04.001. Epub 2014 Apr 13.
PubMed 24793786Nicholls AR, Levy AR, Meir R, Sanctuary C, Jones L, Baghurst T, Thompson MA, Perry JL. The development and validation of the Adolescent Sport Drug Inventory (ASDI) among athletes from four continents. Psychol Assess. 2019 Nov;31(11):1279-1293. doi: 10.1037/pas0000750. Epub 2019 Jul 18.
PubMed 31318254
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRUE CHAMPION: An Educational Videogame Intervention for the Prevention of Doping and Supplement Abuse in Teenage Athletes
- ClinicalTrials.gov ID
- NCT04203992
- Acronym / sponsor ID
- 476-0418
- Conditions
- Doping in Sport, Performance Enhancing Product Use
- Keywords
- Student athletes, Supplements, Videogame
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- International Olympic Committee, World Anti-Doping Agency, Phantom Compass, Digitalmill, Inc.
- Study start
- Nov 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test the effectiveness of an interactive doping education videogame among student athletes. Specifically, the game will teach athletes aged 13-16 years about the risks of doping and will foster the values, motivation, and behavioural skills needed to avoid temptation and pressure to dope. The investigators hypothesize that student athletes who play the intervention game will have lower use of banned substances and sport supplements, greater intentions to stay clean, and will also show improvements in the cognitive and motivational antecedents to doping when compared to a control condition.
Detailed description
284 student athletes will be enrolled in this two-arm quasi-experimental study. The participants will be boys and girls, aged 13 to 16 years who compete in any sport. Participants will be recruited and enrolled through partnerships with their school physical education and/or sport programs. Participants will complete baseline questionnaires assessing demographics, history of sport participation, and psychological variables related to doping prevention including knowledge, doping self-regulatory efficacy, motivation, attitudes, intentions, perceived norms, doping refusal, substance use behaviours, and doping related protective behaviours (e.g., checking the list of ingredients on medications). Participants will then be assigned to either an intervention group (n = 142; the doping videogame the investigators are developing) or a comparison group (n = 142). The comparison group will be given printed educational materials about doping education, developed by an accredited source (e.g., UNESCO). Assignment to the intervention or comparison group will be conducted at the level of the school to reduce the potential for contamination that could occur if intervention and comparison students were interacting in their school environment and sharing information they learned from the game. Participants from the intervention group will play five, 60-minute sessions over the course of one month (5 hours of total gameplay). Before the gameplay sessions begin, the Project Director and research assistants will orient the intervention group participants to the use of the intervention videogame. Players will be given a tutorial on an iPad demonstrating the mechanics of the game and how to use the iPad. Each player will have their own dedicated iPad that they will use during each game play session (this will be provided by the research team). Shortly after the last gameplay session is completed, participants from both groups will be asked to complete a questionnaire assessing the same psychological variables assessed at baseline as well as their gameplay experience. The psychological variables will also be assessed at three, six, and 12 month follow-ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We aim to enroll 284 male and female student-athletes between the ages of 13 and 16. Participants will be assigned to either an intervention group (n = 142) or a comparison group (n = 142).
| Arm | Type | Receives |
|---|---|---|
| Videogame | Experimental | Behavioral: VideogameEducational videogame, five 60-minute sessions over one month |
| Booklet | Active comparator | Behavioral: ControlEducational booklet, one session |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subject competes in a competitive sport at the high school level or higher
- Able to read and understand English
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideogameTrue Champion is an educational, values-based game that aims to empower young athletes to make informed decisions to avoid doping. Participants engaging in the videogame sessions will encounter a series of thought-provoking situations and knowledge tests. Players will help their assigned character navigate through these curriculum-rich scenarios in order to reach their performance goals in a healthy and ethical way. | Behavioural | Videogame |
| ControlParticipants will be given an anti-doping booklet prepared by UNESCO. This booklet is considered standard educational material, i.e. what might be presented to young athletes as part of their regular sports curriculum. | Behavioural | Booklet |
Primary outcome
Use of banned substances
Time frame: 12 months
Self-reported use of banned substances for performance enhancement or recovery in sport. This outcome will be measured using a self-reported questionnaire. Scale: Performance-Enhancing Substances and Methods Use Minimum value: 1 - extremely unlikely (better outcome) Maximum value: 7 - extremely likely (worse outcome)
Use of sport supplements
Time frame: 12 months
Self-reported use of supplements for performance enhancement or recovery in sport. This outcome will be measured using a self-reported questionnaire. Scale: Performance-Enhancing Substances and Methods Use Minimum value: 1 - extremely unlikely (better outcome) Maximum value: 7 - extremely likely (worse outcome)
Intentions to use banned substances and sport supplements
Time frame: 12 months
Self-reported intentions of using banned substances or supplements for performance enhancement or recovery in sport. This outcome will be measured using a self-reported questionnaire. Scale: Performance-Enhancing Substances and Methods Use Minimum value: 1 - extremely unlikely (better outcome) Maximum value: 7 - extremely likely (worse outcome)
7 secondary outcomes
Knowledge
Time frame: 12 months
Doping Self-Regulatory Efficacy
Time frame: 12 months
Motivation
Time frame: 12 months
Attitudes
Time frame: 12 months
Anti-doping protective behaviours
Time frame: 12 months
Doping refusal
Time frame: 12 months
Gameplay experience
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 20606508Goulet C, Valois P, Buist A, Cote M. Predictors of the use of performance-enhancing substances by young athletes. Clin J Sport Med. 2010 Jul;20(4):243-8. doi: 10.1097/JSM.0b013e3181e0b935.
- BackgroundBoardley I, Smith AL, Mills JP, Grix J, Wynne C., & Wilkins L. Development of Moral Disengagement and Self-Regulatory Efficacy Assessments Relevant to Doping in Sport and Exercise. SportRxiv, 12 Oct. 2017. Web.
- Background: PubMed 24793786Chan DK, Dimmock JA, Donovan RJ, Hardcastle S, Lentillon-Kaestner V, Hagger MS. Self-determined motivation in sport predicts anti-doping motivation and intention: a perspective from the trans-contextual model. J Sci Med Sport. 2015 May;18(3):315-22. doi: 10.1016/j.jsams.2014.04.001. Epub 2014 Apr 13.
- Background: PubMed 31318254Nicholls AR, Levy AR, Meir R, Sanctuary C, Jones L, Baghurst T, Thompson MA, Perry JL. The development and validation of the Adolescent Sport Drug Inventory (ASDI) among athletes from four continents. Psychol Assess. 2019 Nov;31(11):1279-1293. doi: 10.1037/pas0000750. Epub 2019 Jul 18.
- True Champion WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Doping in Sport
Not yet recruiting
Harm Reduction Intervention for Anabolic-androgenic Steroids Users: a Randomized Controlled Trial
Drug Abuse, Harm Reduction
RecruitingObservational study
Prospective, Longitudinal Study on FItness DOping in DenmarK
Anabolic Steroid Overdose, Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay R Duncan, PhD principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
A study testing Videogame in people with Doping in Sport and Performance Enhancing Product Use, run by McGill University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindsay R Duncan, PhD (514-398-4184 ext. 00919, lindsay.duncan@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of banned substances (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04203992, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.