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

Study Overview
=================
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.

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

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


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10 schools will receive the experimental CATCH My Breath program and 10 schools will receive the usual care Texas Education Agency required tobacco prevention program. Each school will include 70 students.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CATCH My Breath (CMB) program for E-cigarette prevention among adolescents<br>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<br>* 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.<br>|
| Active Comparator: Texas Education Agency required tobacco prevention program<br>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<br>* 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'<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E-cigarette Prevention