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

NCT06483412 | Enrolling By Invitation DMC

• 1 other identifier: IRB-75499
• Study Type: interventional
• Target: 2,540
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation; Addiction

Keywords

Tobacco Use; Tobacco Use Cessation; E-Cigarette Use; Suspension

Outcome Measures

Primary Outcomes (1)

• Change in tobacco/nicotine use

  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.

  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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

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.

Behavioral: Healthy Futures: Alternative-to-Suspension Curriculum

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).

Behavioral: Healthy Futures: Alternative-to-Suspension Curriculum

Interventions

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.

Delay In Treatment; Stanford REACH Lab Healthy Futures Curriculum

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• California School-Based Health Alliance: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Behavior, Addictive; Tobacco Use; Vaping

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior; Smoking

Study Officials

• Bonnie Halpern-Felsher, Ph.D

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marron and Mary Elizabeth Kendrick Professor in Pediatrics II

Model Details: Employs a step-wedged design that involves delay-of-treatment for the control group. Prognostic blocks of schools will be assigned to treatment (10 schools) versus delay-in-treatment (10 schools) in Year 1 of the intervention. In Years 2 and 3, the 10 schools that served as "control" schools will cross over and implement the Healthy Futures: Alternative-to-Suspension intervention.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)