[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628360":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":33,"locations":40,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":95,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"E-Invite Only VR: A Virtual Reality E-Cigarette Prevention Intervention","EXPERIMENTAL","Participants in this arm will receive the E-Invite Only VR intervention, a school-based, virtual reality (VR) e-cigarette prevention program designed for 8th-grade students. The intervention leverages immersive VR technology and interactive gameplay to educate students about the risks of e-cigarette use, develop their refusal skills, and promote mental health awareness.\n\nStudents will engage in role-playing scenarios where they practice resisting peer pressure and making informed decisions about vaping. The intervention integrates social and emotional learning (SEL) principles, focusing on emotional regulation and healthy coping strategies to reduce the likelihood of e-cigarette initiation.\n\nThe VR-based intervention will be delivered over multiple class sessions, totaling approximately 2-2.5 hours of gameplay. Trained school staff and research personnel will oversee implementation during school hours.",[13],"Behavioral: Virtual Reality E-Cigarette Prevention Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Wait-list Control (Standard Health Curriculum)","NO_INTERVENTION","Participants in this arm will receive the standard e-cigarette prevention education currently provided by their school as part of the existing health curriculum. Unlike the intervention arm, students in the control group will not have access to the E-Invite Only VR program during the study period.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Virtual Reality E-Cigarette Prevention Program","The E-Invite Only VR intervention is a school-based, virtual reality (VR) e-cigarette prevention program designed for 8th-grade students. It is an enhanced version of the Invite Only VR game, incorporating mental health promotion content alongside e-cigarette prevention education. The intervention leverages interactive gameplay to build emotion regulation skills and increase students' ability to resist peer pressure to use e-cigarettes. It aligns with behavior change theories, including the Theory of Planned Behavior and Social Cognitive Theory, to improve knowledge, harm perceptions, and self-efficacy related to vaping prevention",[9],[26],"E-Invite Only",[28,31],{"name":29,"affiliation":5,"role":30},"Kimberly Hieftje D Associate Professor of Pediatrics, PhD","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":5,"role":30},"Deepa Camenga Associate Professor of Emergency Medicine, MD",[34,38],{"name":29,"role":35,"phone":36,"phoneExt":18,"email":37},"CONTACT","12037375595","kimberly.hieftje@yale.edu",{"name":32,"role":35,"phone":18,"phoneExt":18,"email":39},"deepa.camenga@yale.edu",[41],{"facility":42,"status":18,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Yale School of Medicine","New Haven","Connecticut","06510","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-72.92816,41.30815,{"lat":52,"lon":51},[55],{"name":56,"role":35,"phone":57,"phoneExt":18,"email":37},"Kimberly Hieftje Associate Professor of Pediatrics, PhD","203-737-5595",{"type":59,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[61],{"name":62,"class":63},"National Cancer Institute (NCI)","NIH","100628360","a-virtual-reality-e-cigarette-prevention-and-emotion-regulation-intervention-for-adolescents-100628360",false,"NCT07460622","A Virtual Reality E-cigarette Prevention and Emotion Regulation Intervention for Adolescents","E-cigarette Prevention and Emotion Regulation: Virtual Reality Intervention for Adolescents","Inclusion Criteria\n\n* Enrolled in the 8th grade in one of the 20 partner middle schools (8 in Connecticut, 12 in Massachusetts).\n* Willing to participate in a VR videogame for approximately 45 minutes per session, accumulating 2-2.5 hours of total gameplay across multiple class periods.\n* Able to provide assent and obtain parental\u002Fguardian consent before participating in the study.\n\nExclusion Criteria\n\n* Students not enrolled in 8th grade at one of the participating schools.\n* Students who are unwilling or unable to participate in VR gameplay for the required duration.\n* Students who cannot provide assent or do not have parental\u002Fguardian consent to participate .",true,"ALL","11 Years","15 Years",{"count":76,"type":77},1251,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study will examine E-Invite Only VR, a novel school-based universal e-cigarette prevention intervention that uses virtual reality (VR) to deliver prevention and emotion regulation skills-building content to middle school students in real-world classrooms. If successful, E-invite Only VR has the potential to prevent adolescents from experiencing a multitude of poor health outcomes related to nicotine vaping, including cancer.",[83,84,85],"E-cigarette Use\u002FVaping Prevention","Nicotine Dependence Prevention","Adolescent Mental Health",[87,88,89,90,91,92,93,94],"E-cigarette prevention","Vaping prevention","Nicotine addiction prevention","Virtual reality intervention","School-based prevention program","Mental health and substance use","Digital health intervention","emotion regulation skills","NOT_YET_RECRUITING","2026-03-03",{"date":98,"type":99},"2026-03-10","ACTUAL",{"date":101,"type":77},"2026-10-01",{"date":103,"type":77},"2028-06",{"name":5,"class":6},1]