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Completed

NCT Number: NCT04843501

Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath

This is a two-arm, cluster randomized trial designed to to evaluate the effectiveness of an e-cigarette curriculum [called the CATCH My Breath (CMB) program] in delaying the onset of e-cigarette use in middle schoolers. Schools will be assigned to either the CMB program or usual care, which is Texas Education Agency (TEA) required tobacco prevention program. 10 schools will be assigned to each arm arm, and each school will include 70 students in the study, for a total of 700 students per arm and 1400 total students in the study. Both programs will be administered to participating students over 3 years.

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Key information

Conditions

E-cigarette Use Behavior Smoking Vaping

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston School of Public Health at Austin

Austin, Texas, 78701, United States

About this study

The goal of this research is to empirically assess the three year immediate effects and 12 year follow-up of the CATCH My Breath (CMB) program on delaying the onset of e-cigarette use with a 6th-9th grade cohort, using a 20-school group randomized controlled trial (RCT), with 1,400 students. E-cigarettes are the most commonly used tobacco product by US youth. Recent research, strongly suggests that youth who only smoke e-cigarettes exhibit symptoms of addiction, and are more likely to experiment combustible tobacco. Unfortunately, few e-cigarette prevention programs exist, and none have been tested for longer-term efficacy. Although some tobacco prevention programs have included an e-cigarette add -on component, to our knowledge, none of these revised programs have been formally evaluated. The lack of e-cigarette specific program content, and lack of rigorous evaluation, warrants the proposed project. CMB was developed with input from school administrators, health education coordinators, tobacco prevention educators, classroom teachers, students, and parents. CMB has been formatively evaluated and pilot tested at 59 middle schools in 7 states, resulting in positive feedback from over 100 middle school teachers and 9,578 6th-8th grade students. Our second pilot pretest-posttest controlled experiment (2017-2018), and resulted in an treatment-control difference of 3.8% in ever smoking over a 16-month period. Given CMB's current popularity with schools as a 'best practice' program, and with initial positive results, a full scale randomized control trial is needed to determine longer term, 6th-9th grade efficacy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

School Inclusion Criteria:

  • enrollment of at least 70 students in each of the 6th, 7th, and 8th grades
  • school location is 100 miles of research site

School Exclusion Criteria:

  • schools that have participated in the previous 2 pilot tests
  • currently implementing CMB

Student Inclusion Criteria:

  • enrollment in the 6th grade at a study school
  • willingness to complete the measurements six times during the study

Student Exclusion Criteria:

  • severe disabilities that limit their participation

Parent Inclusion Criteria:

  • ability to communicate in English or Spanish
  • caretaker of a 6th-grade child.

Parent Exclusion Criteria:

-inability to communicate in English or Spanish

Treatment and study plan

CATCH My Breath (CMB) program for E-cigarette prevention among adolescents

Behavioral

CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. Strategies include small and large group discussions, parent interviews, role-plays, media literacy, and goal setting. E-cigarette focused science and humanities activities (2 per school year) are also provided. An informational tool kit will be provided to parents. Finally, 8 activity-based E-cig PE lessons are intended for either 7th or 8th grades, depending on school calendar. CMB provides study materials to teachers through an online access portal. A site-based management team will oversee program implementation. Teachers in CMB intervention schools will be provided with CMB-specific training for implementing the lessons with fidelity through a one-hour live webinar, offered at multiple times to accommodate teaching schedules. Project staff will meet routinely with participating schools to answer study questions.

Texas Education Agency (TEA) required tobacco prevention program

Behavioral

The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes TEA developed online lessons and support materials and also includes elements of the CDC Know the Risks e-cigarette prevention program. This can be considered 'usual care'

Primary outcomes

  1. Number of Students Who Currently Use E-cigarettes

    Time frame: baseline

    Current use is defined as e-cigarette use in the last 30 days.

  2. Number of Students Who Currently Use E-cigarettes

    Time frame: 3 years

    Current use is defined as e-cigarette use in the last 30 days.

  3. Number of Students Who Have Ever Used E-cigarettes in Their Lifetime

    Time frame: baseline

  4. Number of Students Who Have Ever Used E-cigarettes in Their Lifetime

    Time frame: 3 years

  5. Number of Students Who Are Susceptible to E-cigarette Use

    Time frame: baseline

    Susceptibility to e-cigarette use is defined as never used an e-cigarette but having tendencies that indicate that e-cigarette use is likely. Susceptibility is assessed with a questionnaire that asks "Do any of your friends use e-cigarettes?," "Are you curious about e-cigarettes?," and "Do you think you will try an e-cigarette in the next year?" Yes to any of these three questions indicates susceptibility to e-cigarette use.

  6. Number of Students Who Are Susceptible to E-cigarette Use

    Time frame: 3 years

    Susceptibility to e-cigarette use is defined as never used an e-cigarette but having tendencies that indicate that e-cigarette use is likely. Susceptibility is assessed with a questionnaire that asks "Do any of your friends use e-cigarettes?," "Are you curious about e-cigarettes?," and "Do you think you will try an e-cigarette in the next year?" Yes to any of these three questions indicates susceptibility to e-cigarette use.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Middle School Cluster RCT to Evaluate E-Cigarette Prevention Program: CATCH My Breath

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2021
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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