NCT05493982

Brief Summary

The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. A set of lessons focused on e-cigarette/vaping prevention education specifically is called the Be Vape Free curriculum. The aims of this study are to determine: (1) whether the Be Vape Free curriculum is effective in increasing middle and high school students' resistance to using tobacco and in decreasing positive attitudes towards and intentions to use e-cigarettes; (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco; and (3) Examine heterogenous treatment effects identifying groups that benefit the most and those who do not benefit at all from the intervention.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,800

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Oct 2022Jun 2026

First Submitted

Initial submission to the registry

August 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 19, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

August 6, 2022

Last Update Submit

December 17, 2025

Conditions

Keywords

youthtobaccoeducationhealthpreventionvapinge-cigarette

Outcome Measures

Primary Outcomes (2)

  • Change in e-cigarette use

    Investigator-originated survey measures (questions) assess ever e-cigarette use \& past 30-day tobacco use. This outcome measure assesses e-cigarette use.

    Change from baseline to follow-up at approximately 156 weeks

  • Change in intention to use of e-cigarettes scaled score as measured by investigator-originated survey

    This survey measures change in intention to use e-cigarettes with questions related to the participant's knowledge of and resistance to use of e-cigarettes.

    Change from baseline to follow-up at approximately 156 weeks

Study Arms (3)

Receives Stanford vaping prevention curriculum (pilot phase)

EXPERIMENTAL

Stanford vaping prevention curriculum is administered as pilot arm preceding main experimental intervention.

Behavioral: Stanford Vaping Prevention curriculum

Receives Stanford vaping prevention curriculum (randomized phase)

EXPERIMENTAL

Stanford vaping prevention curriculum is administered.

Behavioral: Stanford Vaping Prevention curriculum

Does not receive Stanford vaping prevention curriculum (randomized phase)

NO INTERVENTION

Receives another curriculum or no vaping prevention education.

Interventions

Stanford vaping prevention curriculum delivered as a 5-session course administered in a school classroom setting.

Receives Stanford vaping prevention curriculum (pilot phase)Receives Stanford vaping prevention curriculum (randomized phase)

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Middle school and high school students receiving health education at schools participating in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Officials

  • Bonnie Halpern-Felsher, Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marron and Mary Elizabeth Kendrick Professor in Pediatrics II

Study Record Dates

First Submitted

August 6, 2022

First Posted

August 9, 2022

Study Start

October 19, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations