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

Not Applicable

Active, not recruiting

• Conditions: E-cigarette Use

• Registration Number: NCT04843501
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-12-13
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1790

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of students who currently use e-cigarettes	3 years	Current use is defined as e-cigarette use in the last 30 days.
Number of students who are susceptible to e-cigarette use	3 years	Susceptibility to e-cigarette use is defined as not currently smoking 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.
Number of students who have ever used e-cigarettes in their lifetime	3 years

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston School of Public Health at Austin; 🇺🇸 Austin, Texas, United States