At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Middle School Cluster RCT to Evaluate E-Cigarette Prevention Program: CATCH My Breath
In Brief
A clinical study evaluating CATCH My Breath (CMB) program for E-cigarette prevention among adolescents and Texas Education Agency (TEA) required tobacco prevention program for E-cigarette Use. Completed, enrolled 2,059 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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'