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

E-cigarette Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04843501
• Other study ID #: HSC-SPH-18-0254
• Secondary ID: 5R01CA242171-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 13, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1790
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• E-cigarette Use

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston School of Public Health at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of students who currently use e-cigarettes	Current use is defined as e-cigarette use in the last 30 days.	baseline
Primary	Number of students who currently use e-cigarettes	Current use is defined as e-cigarette use in the last 30 days.	3 years
Primary	Number of students who have ever used e-cigarettes in their lifetime		baseline
Primary	Number of students who have ever used e-cigarettes in their lifetime		3 years
Primary	Number of students who are susceptible to e-cigarette use	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.	baseline
Primary	Number of students who are susceptible to e-cigarette use	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.	3 years