Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 9:54 AM
Study NCT ID:
NCT07413432
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2025-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Virtual Reality Game to Prevent E-cigarette and Cannabis Vaping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002189', 'term': 'Marijuana Abuse'}, {'id': 'D000072137', 'term': 'Vaping'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-group pre-post quasi-experimental study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Assessed Using Change in Retention Rates', 'timeFrame': 'From enrollment to the end of the last gameplay session, up to 1.5 hrs', 'description': 'Feasibility will be measured the number of participants that completed the assigned intervention.'}, {'measure': 'Acceptability Assessed Via Self-reported Survey', 'timeFrame': 'End of Final Gameplay Session, up to 1.5 hrs', 'description': 'Acceptability of the intervention is assessed via self-reported survey at the post-gameplay time point using the game experience and satisfaction questionnaire, which is a 12-item scale custom-created for this study with 4-point Likert-type responses ranging from 1 (strongly disagree) to 4 (strongly agree). Total score range 12-42. Higher scores indicate stronger agreement with the statement.'}, {'measure': 'Usability of the Intervention Assessed via Self-Reported Survey', 'timeFrame': 'End of Final Gameplay Session, up to 1.5 hrs', 'description': 'Usability of the intervention will be assessed via self-reported survey at the post-gameplay time point using the System Usability Scale (SUS), which is a 10-item scale with 5-point Likert-type responses ranging from 1 (strongly disagree) to 5 (strongly agree). Total score range 10-50. Higher scores indicate stronger agreement with the statement.'}], 'secondaryOutcomes': [{'measure': 'Change in Intentions to Use E-cigarettes from Pre- to Post-Intervention', 'timeFrame': 'Baseline and immediately following the last gameplay session, up to 1.5 hrs.', 'description': 'Changes in intentions to use e-cigarettes will be assessed using the Pierce Susceptibility Measure, at the post-gameplay time point which is a 4-item scale with 4-point Likert-type responses ranging from 1 (Definitely yes) to 4 (Definitely not). Total score range 4-16. Higher scores indicate greater intentions to use e-cigarettes.'}, {'measure': 'Change in Nicotine and Cannabis Harm Perceptions', 'timeFrame': 'Baseline and immediately following the last gameplay session up to 1.5 hrs.', 'description': 'Change in nicotine and cannabis harm perceptions will be assessed using a 6-item survey created by the research team using a 5-point Likert scale. Total score range is 6-30. Lower scores indicate low harm perceptions.'}, {'measure': 'Changes in Nicotine and Cannabis Vape Knowledge', 'timeFrame': 'Baseline and immediately following the last gameplay session, up to 1.5 hrs.', 'description': "Changes in nicotine and cannabis vape knowledge will be assessed using an 8-item survey created by the research team. Responses include True, False, and I Don't Know."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaping', 'cannabis', 'prevention', 'videogame', 'virtual reality', 'adolescents', 'emotion regulation'], 'conditions': ['Cannabis', 'Vaping', 'Emotion Regulation']}, 'descriptionModule': {'briefSummary': "The goal of this study is to develop and test an adapted version of our virtual reality videogame intervention prototype, Invite Only VR, developed for middle school students, which focuses on e-cigarette and marijuana vaping prevention. The game also includes a focus on emotion regulation and healthy coping skills. To determine the preliminary impact of the intervention, investigators will collect acceptability and feasibility data from 6th-8th grade students across three Connecticut middle schools. Investigators will also collect data on participants' knowledge, harm perceptions, and intentions to vape before and after they have played the videogame intervention.", 'detailedDescription': 'The goal of this project is to develop and evaluate an evidence-based classroom-based e-cigarette and marijuana vaping prevention videogame for 6th to 8th grade students in three CT middle schools. To determine the preliminary impact of the intervention, investigators will measure the following : 1) students who complete the entire intervention (target outcome \\>90%), 2) acceptability of the intervention among 6th-8th grade students and school administration associated with delivery of the intervention (target outcome \\>90% report it is acceptable); 3) the intervention will be reported as feasible to implement by school administration(target outcome \\>90% report it is feasible); 4) students will increase knowledge of marijuana and nicotine vaping harms (target outcome pre-post knowledge and harm perceptions test score will have a statistically significant increase, 5) students will reduce their intentions to vape (target outcome pre-post intentions to vape will have a statistically significant decrease in scores). Findings from this research study will produce the first theory-driven, evidence-based, novel VR videogame intervention focused on both e-cigarette and marijuana vaping in adolescents, a key population that needs engaging interventions designed specifically for them, and will provide acceptability and preliminary efficacy data to inform a larger-scale effectiveness-implementation trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* enrolled at a participating middle school in CT\n* speak English\n* attending 6th, 7th, or 8th grade\n* be willing to play a virtual reality videogame for 45-60 minutes/session\n* ability to provide assent or parental/guardian consent\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT07413432', 'briefTitle': 'A Virtual Reality Game to Prevent E-cigarette and Cannabis Vaping', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Virtual Reality Videogame for E-cigarette and Cannabis Prevention in Teens', 'orgStudyIdInfo': {'id': '2000025177_sub3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Invite Only VR Intervention Only Group', 'description': 'All participants in the study will play the virtual reality videogame intervention, Invite Only VR. The game was developed for middle school students and focuses on e-cigarette and cannabis vaping prevention. The game also includes content and skill-development related to emotion regulation and healthy coping.', 'interventionNames': ['Behavioral: Virtual reality videogame intervention for vaping prevention']}], 'interventions': [{'name': 'Virtual reality videogame intervention for vaping prevention', 'type': 'BEHAVIORAL', 'otherNames': ['Invite Only VR'], 'description': 'Invite Only VR is an immersive virtual reality game designed to help adolescents build knowledge, awareness, and refusal skills around vaping through interactive, story-based social scenarios. The latest version expands its focus to include both nicotine and cannabis vaping, offering players realistic opportunities to navigate peer pressure and practice informed decision-making', 'armGroupLabels': ['Invite Only VR Intervention Only Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Kimberly Hieftje, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Deepa Camenga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CT Department of Public Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}