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临床试验/NCT06483412
NCT06483412Enrolling By Invitation不适用

Evaluation Tobacco Prevention Toolkit Healthy Futures: Alternative-to-Suspension Vaping Intervention

Stanford University1 个研究点 分布在 1 个国家目标入组 2,540 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
2,540
试验地点
1
主要终点
Change in tobacco/nicotine use

研究概览

简要总结

The Healthy Futures: Alternative-to-Suspension Curriculum is a free, online curriculum developed to educate students and provide them with resources to quit tobacco/nicotine 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/nicotine.

详细描述

Youth who use tobacco/nicotine 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.

The 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/susceptibility to use, and actual use of tobacco/nicotine 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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for schools
  • •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/school health officer/school 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 participants Adolescents, aged 14-18, from grades 9-12, who are agreeable to participate in the study and provide assent.

排除标准

  • •Adolescents, aged 14-18 years, from grades 9-12 who do not speak English.

研究组 & 干预措施

Stanford REACH Lab Healthy Futures Curriculum

Experimental

At the start of Year 1, schools will be randomized in a 1:1 ratio to either receive 'Stanford REACH Lab's Healthy Futures: Alternative-to-Suspension Curriculum' or 'delay-in-treatment (standard of care)'. Students in these schools who are found using tobacco/nicotine or who want to quit these products will be administered the Healthy Futures: Alternative-to-Suspension curriculum for 3 years.

干预措施: Healthy Futures: Alternative-to-Suspension Curriculum (Behavioral)

Delay In Treatment

Experimental

At the start of Year 1, schools will be randomized in a 1:1 ratio to either receive 'Stanford REACH Lab's Healthy Futures: Alternative-to-Suspension Curriculum' or 'delay-in-treatment (standard of care).' Schools in this arm will receive a standard of care for one year. After year 1, the delay-in-treatment group will crossover to receive 'Stanford REACH Lab's Healthy Futures: Alternative-to-Suspension Curriculum until year 3 (receive intervention for years 2 and 3).

干预措施: Healthy Futures: Alternative-to-Suspension Curriculum (Behavioral)

结局指标

主要结局

Change in tobacco/nicotine use

时间窗: 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.

Investigator-originated survey measures (questions) ever tobacco/nicotine use and past 30-day tobacco/nicotine 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.

次要结局

  • Change in intention of tobacco/nicotine use scale score(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bonnie Halpern-Felsher

Marron and Mary Elizabeth Kendrick Professor in Pediatrics II

Stanford University

研究点 (1)

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