Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT04203992
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2019-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Videogame for the Prevention of Doping and Supplement Abuse in Teenage Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2019-12-11', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of banned substances', 'timeFrame': '12 months', 'description': 'Self-reported use of banned substances for performance enhancement or recovery in sport.\n\nThis outcome will be measured using a self-reported questionnaire.\n\nScale: Performance-Enhancing Substances and Methods Use\n\nMinimum value: 1 - extremely unlikely (better outcome)\n\nMaximum value: 7 - extremely likely (worse outcome)'}, {'measure': 'Use of sport supplements', 'timeFrame': '12 months', 'description': 'Self-reported use of supplements for performance enhancement or recovery in sport.\n\nThis outcome will be measured using a self-reported questionnaire.\n\nScale: Performance-Enhancing Substances and Methods Use\n\nMinimum value: 1 - extremely unlikely (better outcome)\n\nMaximum value: 7 - extremely likely (worse outcome)'}, {'measure': 'Intentions to use banned substances and sport supplements', 'timeFrame': '12 months', 'description': 'Self-reported intentions of using banned substances or supplements for performance enhancement or recovery in sport.\n\nThis outcome will be measured using a self-reported questionnaire.\n\nScale: Performance-Enhancing Substances and Methods Use\n\nMinimum value: 1 - extremely unlikely (better outcome)\n\nMaximum value: 7 - extremely likely (worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Knowledge', 'timeFrame': '12 months', 'description': 'Knowledge of anti-doping rules, definitions and consequences of doping.\n\nThis outcome will be assessed using a True/False questionnaire.'}, {'measure': 'Doping Self-Regulatory Efficacy', 'timeFrame': '12 months', 'description': 'Self-efficacy for refusing doping under a variety of pressure situations.\n\nThis outcome will be measured using a validated questionnaire.\n\nScale: Doping Self-Regulatory Efficacy\n\nMinimum value: 1 - no confidence (better outcome)\n\nMaximum value: 5 - complete confidence (worse outcome)'}, {'measure': 'Motivation', 'timeFrame': '12 months', 'description': 'Motivations for abstaining from doping.\n\nThis outcome will be measured using an adaptation of a validated questionnaire.\n\nScale: Treatment Self-Regulation Questionnaire for the Avoidance of Doping in Sport\n\nMinimum value: 1 - not true at all (worse outcome)\n\nMaximum value: 7 - very true (better outcome)'}, {'measure': 'Attitudes', 'timeFrame': '12 months', 'description': 'Attitudes towards doping in sport.\n\nThis outcome will be measured using a subscale from a validated questionnaire.\n\nScale: The Adolescent Sport Doping Inventory\n\nMinimum value: 1 - strongly disagree (worse outcome)\n\nMaximum value: 7 - strongly agree (better outcome)\n\nNote: some items are reverse-scored'}, {'measure': 'Anti-doping protective behaviours', 'timeFrame': '12 months', 'description': 'Self-reported engagement in behaviours linked to doping abstinence.\n\nScale: Microbehaviours\n\nMinimum value: 1 - never (worse outcome)\n\nMaximum value: 7 - always (better outcome)'}, {'measure': 'Doping refusal', 'timeFrame': '12 months', 'description': 'Self-report of having refused a supplement or performance-enhancing substance.\n\nThis outcome will be assessed using a Yes (worse outcome) or No (better outcome) questionnaire.'}, {'measure': 'Gameplay experience', 'timeFrame': '1 month', 'description': 'Enjoyment and acceptability of the True Champion videogame among players assigned to the intervention condition.\n\nThis outcome will be assessed using a questionnaire we have created. Answers will range from "strongly disagree" to "strongly agree".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Student athletes', 'Supplements', 'Videogame'], 'conditions': ['Doping in Sport', 'Performance Enhancing Product Use']}, 'referencesModule': {'references': [{'pmid': '20606508', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Boardley 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.'}, {'pmid': '24793786', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31318254', 'type': 'BACKGROUND', 'citation': 'Nicholls 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.'}], 'seeAlsoLinks': [{'url': 'http://truechampion.ca', 'label': 'True Champion Website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject competes in a competitive sport at the high school level or higher\n* Able to read and understand English\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04203992', 'briefTitle': 'Videogame for the Prevention of Doping and Supplement Abuse in Teenage Athletes', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'TRUE CHAMPION: An Educational Videogame Intervention for the Prevention of Doping and Supplement Abuse in Teenage Athletes', 'orgStudyIdInfo': {'id': '476-0418'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Videogame', 'description': 'Educational videogame, five 60-minute sessions over one month', 'interventionNames': ['Behavioral: Videogame']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Booklet', 'description': 'Educational booklet, one session', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Videogame', 'type': 'BEHAVIORAL', 'description': 'True Champion is an educational, values-based game that aims to empower young athletes to make informed decisions to avoid doping.\n\nParticipants 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.', 'armGroupLabels': ['Videogame']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Booklet']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lindsay R Duncan, PhD', 'role': 'CONTACT', 'email': 'lindsay.duncan@mcgill.ca', 'phone': '514-398-4184', 'phoneExt': '00919'}, {'name': 'Evelyne Bedard, MSc', 'role': 'CONTACT', 'email': 'evelyne.bedard@mcgill.ca', 'phone': '514-398-4814', 'phoneExt': '09976'}], 'overallOfficials': [{'name': 'Lindsay R Duncan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Olympic Committee', 'class': 'UNKNOWN'}, {'name': 'World Anti-Doping Agency', 'class': 'OTHER'}, {'name': 'Phantom Compass', 'class': 'UNKNOWN'}, {'name': 'Digitalmill, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, William Dawson Scholar', 'investigatorFullName': 'Lindsay Duncan', 'investigatorAffiliation': 'McGill University'}}}}