Pilot Study of the YES-CAN! Program to Prevent Youth Nicotine Vaping

NCT07009509 | Recruiting

• 2 other identifiers: 23-13965R34DA058218
• Study Type: interventional
• Target: 1,166
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to determine the feasibility of a randomized trial of the YES-CAN! (Youth Engaged Strategies to Change Adolescent Norms) program to prevent nicotine vaping among adolescents. The program integrates the following evidence-based strategies: youth-adult collaboration; youth-developed narrative videos to convey health messages; peer leaders as change agents; and sustained implementation to change the normative environment. Two middle/high school communities will receive the YES-CAN! intervention. In each school community, a trained teacher will deliver a credit-earning middle or high school class to 25-30 middle or high school students, who will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among current users. Videos will use a narrative approach and integrate known determinants of vaping. Middle or high school students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. In 6-8 sessions, middle or high school students will deliver their videos to all students in the associated middle school. A text messaging or other media component will reinforce and boost the effectiveness of the classroom sessions. Aims for this pilot/feasibility study are:

1. 1.To determine the feasibility and acceptability of implementing the YES-CAN! program
2. 2.To determine the feasibility and acceptability of the research protocols that will be used in a future efficacy trial

Conditions

Nicotine Vaping

Keywords

Nicotine Vaping; Adolescents; School; Behavior change; Social norms; Electronic cigarettes

Outcome Measures

Primary Outcomes (3)

• Ever vaped at baseline

  Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)

  Baseline

• Ever vaped at 9 months

  Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)

  9 months

• Every vaped at 12 months

  Whether participant has ever vaped, even once or twice. Scores range from "no" (0) to "yes" (1)

  12 months

Secondary Outcomes (24)

• Vaping susceptibility at baseline

  Baseline

• Vaping susceptibility at 9 months

  9 months

• Vaping susceptibility at 12 months

  12 months

• Days vaped in the past month at baseline

  Baseline

• Days vaped in past 30 days at 9 months

  9 months

Study Arms (1)

YES-CAN! Intervention

EXPERIMENTAL

A credit-earning middle or high school course that includes curriculum related to vaping, health risk communication, and video production will be established and approximately 25-30 students will be enrolled. Students will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among middle school students. Videos will use a narrative approach and integrate known determinants of vaping. Students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. Students will deliver their videos, along with discussion and supportive activities, to all students in the associated middle school. A text message campaign will reinforce and boost the effectiveness of the classroom sessions.

Behavioral: YES-CAN! program

Interventions

YES-CAN! program BEHAVIORAL

Youth Engaged Strategies to Change Adolescent Norms

YES-CAN! Intervention

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children enrolled in middle school grades 6-8 and high school grades 9-12 (age approximately 10-13 and 14-17); adults (over age 18) involved in educational system

You may not qualify if:

• Not able to read and write in English or Spanish

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (23)

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  PMID: 30166079 BACKGROUND

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  PMID: 35678642 BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Lori A Crane, PhD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Nancy L Asdigian, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori A Crane, PhD, MPH

CONTACT

3037244385; lori.crane@cuanschutz.edu

Nancy L Asdigian, PhD

CONTACT

7203243748; nancy.asdigian@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A credit-earning high school course that includes curriculum related to vaping, health risk communication, and video production will be established and approximately 25-30 10th through 12th grade students will be enrolled. High school students will produce 6-8 short videos intended to increase refusal skills; promote stress management and positive coping; change social norms; prevent vaping initiation; and promote vaping cessation among middle school students. Videos will use a narrative approach and integrate known determinants of vaping. High school students will collaborate with the teacher and researchers to develop discussion guides and skills-building activities based on best practices for substance use prevention. High school students will deliver their videos, along with discussion and supportive activities, to all students in the associated middle school. A text message campaign will reinforce and boost the effectiveness of the classroom sessions

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: August 15, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Final submission and release of the study data will occur no later than time of an associated publication or end of the performance period, whichever comes first. Study data deposited in DSDR will be available to the research community in perpetuity. All deidentified study data will be made available as public use data to the research community via DSDR.
• Access Criteria: Users of the public use data must register with ICPSR and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.

Locations

US (1)