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Enrolling by Invitation

NCT Number: NCT06483412

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

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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Healthy Futures: Alternative-to-Suspension Curriculum

Behavioral

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.

Primary outcomes

  1. Change in tobacco/nicotine use

    Time frame: 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.

Secondary outcomes

  1. Change in intention of tobacco/nicotine use scale score

    Time frame: 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.

    Participants will self-report changes in their intention/susceptibility to use tobacco/nicotine products using a validated four-point scale in a survey. This survey measures changes in intention to use tobacco/nicotine with questions related to the participant's knowledge of and resistance to the use of tobacco/nicotine products.

    Susceptibility is measured by the following questions:

    • Have you ever been curious about using an e-cigarette?
    • Do you think that you will try an e-cigarette soon?
    • If one of your best friends were to offer you an e-cigarette, would you use it?"

    Response options for all three questions included a four-point scale: "Definitely yes," "Probably yes," "Probably not," and "Definitely not."

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • California School-Based Health Alliance

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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