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

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: E-cigarette Use

Treatments: Behavioral: CATCH My Breath (CMB) program for E-cigarette prevention among adolescents; Behavioral: Texas Education Agency (TEA) required tobacco prevention program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04843501

HSC-SPH-18-0254

5R01CA242171-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,790 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,790 participants in 2 patient groups

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

Experimental group

Description:

The CMB curriculum is divided into four developmentally appropriate e-cigarette lessons (approximately 20-30 minutes each) for middle school aged youth (6th - 8th grade). A variety of educational strategies are used and include cooperative learning groups, large group discussions, interviews, role-play, media, reports, and goal setting. CMB will provide study materials to teachers and schools through a state-of-the art online delivery portal. A site-based management team will oversee program implementation. Teachers will be trained via webinar. Project staff will visit all participating schools to assemble and train the CATCH site-based management team, and answer questions about the study. Teachers in CMB intervention schools will be provided with CMB-specific training for implementing the lessons with fidelity through a one-hour live webinar with Dr. Kelder, which will be offered at multiple times to accommodate teaching schedules.

Treatment:

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

Texas Education Agency required tobacco prevention program

Active Comparator group

Description:

The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.

Treatment:

Behavioral: Texas Education Agency (TEA) required tobacco prevention program