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

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.

Conditions

• E-cigarette Use

Interventions

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.

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'

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Steven H Kelder, PhD, MPH · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-13

Primary Completion

2024-12-20

Completion

2024-12-30

Countries

• United States

Study Locations