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

NCT ID: NCT06483412

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 2540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2027-08-31

Brief Summary

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.

Detailed Description

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).

Conditions

Tobacco Use Cessation; Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Stanford REACH Lab Healthy Futures Curriculum

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.

Group Type: EXPERIMENTAL

Healthy Futures: Alternative-to-Suspension Curriculum

Intervention Type: 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.

Delay In Treatment

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).

Group Type: EXPERIMENTAL

Healthy Futures: Alternative-to-Suspension Curriculum

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

California School-Based Health Alliance

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bonnie Halpern-Felsher

Marron and Mary Elizabeth Kendrick Professor in Pediatrics II

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bonnie Halpern-Felsher, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

IRB-75499

Identifier Type: -

Identifier Source: org_study_id