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

Middle School Cluster 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.

Study Overview

• Status: Active, not recruiting
• Conditions: E-cigarette Use
• Intervention / Treatment: Behavioral: CATCH My Breath (CMB) program for E-cigarette prevention among adolescents; Behavioral: Texas Education Agency (TEA) required tobacco prevention program

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 Type: Interventional
• Enrollment (Actual): 1790
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven H Kelder, PhD, MPH; Phone Number: 713-444-1470; Email: Steven.H.Kelder@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • The University of Texas Health Science Center at Houston School of Public Health at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CATCH My Breath (CMB) program for E-cigarette prevention among adolescents; 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.	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.
Active Comparator: Texas Education Agency required tobacco prevention program; The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.	Behavioral: 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'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of students who currently use e-cigarettes	Current use is defined as e-cigarette use in the last 30 days.	baseline
Number of students who currently use e-cigarettes	Current use is defined as e-cigarette use in the last 30 days.	3 years
Number of students who have ever used e-cigarettes in their lifetime		baseline
Number of students who have ever used e-cigarettes in their lifetime		3 years
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
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven H Kelder, PhD, MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2020
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: E-cigarette Prevention
• Other Study ID Numbers: HSC-SPH-18-0254; 5R01CA242171-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No