Clinical trial NCT06483412: An Evaluation of the Tobacco Prevention Toolkit Healthy Futures: Alternative-to-Suspension Vaping Intervention
Official title: Evaluation Tobacco Prevention Toolkit Healthy Futures: Alternative-to-Suspension Vaping Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Addiction
Keywords: Tobacco Use
Tobacco Use Cessation
E-Cigarette Use
Suspension
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: California School-Based Health Alliance
First posted: 2024-07-03
Enrollment: 2540
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in tobacco/nicotine use
timeFrame: 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:
measure: Change in intention of tobacco/nicotine use scale score
timeFrame: 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.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Bonnie Halpern-Felsher, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: