[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06483412":3,"trial-entities:NCT06483412":81,"trial-summary:NCT06483412":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":45,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":62,"locations":65,"central_contacts":74,"overall_officials":75,"references":79,"see_also_links":80},"NCT06483412","IRB-75499","An Evaluation of the Tobacco Prevention Toolkit Healthy Futures: Alternative-to-Suspension Vaping Intervention","Evaluation Tobacco Prevention Toolkit Healthy Futures: Alternative-to-Suspension Vaping Intervention","ENROLLING_BY_INVITATION","2027-08","2025-11","2025-12-02","2025-03-03","Stanford University","OTHER",true,"The Healthy Futures: Alternative-to-Suspension Curriculum is a free, online curriculum developed to educate students and provide them with resources to quit tobacco\u002Fnicotine use. The investigation aims to estimate the extent to which Healthy Futures: Alternative-to-Suspension changes high school student's knowledge of, attitudes towards, intentions to use, and actual use of tobacco\u002Fnicotine.","Youth who use tobacco\u002Fnicotine products on school campuses are often detained, suspended, or expelled. Healthy Futures: Alternative-to-Suspension is an online curriculum that uses principles of motivational interviewing and cognitive behavioral therapy, incorporating a restorative practice and trauma-informed lens.\n\nThe goals of the study are three-fold: (1) Assess changes in the perspectives of school administrators, educators, counselors, and health staff around the feasibility, acceptability, and usefulness of implementing Healthy Futures: Alternative-to-Suspension as an appropriate and effective response to tobacco use on campus (including versus suspension or expulsion); (2) Assess high school students' acceptability and perceptions of Healthy Futures: Alternative-to-Suspension; and (3) Estimate the extent to which Healthy Futures: Alternative-to-Suspension changes high school students' knowledge of, attitudes towards, intentions\u002Fsusceptibility to use, and actual use of tobacco\u002Fnicotine products. The Stanford REACH Lab and California School-Based Health Alliance (CSHA) will partner to evaluate Healthy Futures: Alternative-to-Suspension using a school-based randomized waitlist-controlled trial in 20 high schools in California (n = 10 Healthy Futures: Alternative-to-Suspension treatment schools and 10 control schools).",[19,20],"Tobacco Use Cessation","Addiction",[22,19,23,24],"Tobacco Use","E-Cigarette Use","Suspension","INTERVENTIONAL","PREVENTION",[28],"NA",{"count":30,"type":31},2540,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Healthy Futures: Alternative-to-Suspension Curriculum","Healthy Futures: Alternative-to-Suspension Curriculum uses a trauma-informed and restorative practice lens and uses principles of motivational interviewing (MI) and cognitive-behavioral therapy (CBT) to help students understand the harms of nicotine, reduce stress, increase positive coping, and provide resources to quit.",[38,39],"Delay In Treatment","Stanford REACH Lab Healthy Futures Curriculum",[41],{"measure":42,"description":43,"timeFrame":44},"Change in tobacco\u002Fnicotine use","Investigator-originated survey measures (questions) ever tobacco\u002Fnicotine use and past 30-day tobacco\u002Fnicotine use. All students in both arms will be asked to complete a survey at baseline (just before treatment), follow-up 1 (immediately post-intervention), follow-up 2 (6 months after completing intervention), and so on every 6 months for 2.5 years of the study.","Baseline, follow-up 1 (following intervention at one year), follow-up 2 (6 months post-intervention), follow-up 3 (6 months past follow-up 2), and follow-up 4 (6 months past follow-up 3) up to 2.5 years of the study.",[46],{"measure":47,"description":48,"timeFrame":49},"Change in intention of tobacco\u002Fnicotine use scale score","Participants will self-report changes in their intention\u002Fsusceptibility to use tobacco\u002Fnicotine products using a validated four-point scale in a survey. This survey measures changes in intention to use tobacco\u002Fnicotine with questions related to the participant's knowledge of and resistance to the use of tobacco\u002Fnicotine products.\n\nSusceptibility is measured by the following questions:\n\n1. Have you ever been curious about using an e-cigarette?\n2. Do you think that you will try an e-cigarette soon?\n3. If one of your best friends were to offer you an e-cigarette, would you use it?\"\n\nResponse options for all three questions included a four-point scale: \"Definitely yes,\" \"Probably yes,\" \"Probably not,\" and \"Definitely not.\"","Baseline, follow-up 1 (following intervention at one year), follow-up 2 (6 months post intervention), follow-up 3 (6 months past follow-up 2), and follow-up 4 (6 months past follow-up 3) up to 2.5 years of the study.","ALL","14 Years","18 Years",{"inclusion":54,"exclusion":60,"raw_text":61},[55,56,57,58,59],"Agree to be randomized to use the Healthy Futures: Alternative-to-Suspension curriculum or to use their current standard of care exclusive of Healthy Futures: Alternative-to-Suspension","Agree that teachers, counselors, or other school personnel will schedule an online survey prior to and after implementation of Healthy Futures: Alternative-to-Suspension or current standard of care with students caught using e-cigarettes or other tobacco products and with students self-reporting use of those products and seeking help to quit","Has access to a school nurse\u002Fschool health officer\u002Fschool counselor or school psychologist","Agree that parental consent, where required, will be sought from students prior to survey administration.","Agree that the study is in the wider interest of the public health of adolescents and in their schools interest.",[],"Inclusion criteria for schools\n\n* Agree to be randomized to use the Healthy Futures: Alternative-to-Suspension curriculum or to use their current standard of care exclusive of Healthy Futures: Alternative-to-Suspension\n* Agree that teachers, counselors, or other school personnel will schedule an online survey prior to and after implementation of Healthy Futures: Alternative-to-Suspension or current standard of care with students caught using e-cigarettes or other tobacco products and with students self-reporting use of those products and seeking help to quit\n* Has access to a school nurse\u002Fschool health officer\u002Fschool counselor or school psychologist\n* Agree that parental consent, where required, will be sought from students prior to survey administration.\n* Agree that the study is in the wider interest of the public health of adolescents and in their schools interest.\n\nInclusion criteria for participants Adolescents, aged 14-18, from grades 9-12, who are agreeable to participate in the study and provide assent.\n\nExclusion Criteria:\n\nAdolescents, aged 14-18 years, from grades 9-12 who do not speak English.",[63,64],"CHILD","ADULT",[66],{"facility":13,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Palo Alto","California","94304","United States",{"lat":72,"lon":73},37.44188,-122.14302,[],[76],{"name":77,"affiliation":13,"role":78},"Bonnie Halpern-Felsher, Ph.D","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":85},[20,83,22,84],"Tobacco Product Use Cessation","Vaping",[],{"nct_id":4,"found":87,"summary":88,"prompt_version":88},false,null]