Clinical trial NCT04843501: Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath
Official title: Middle School Cluster RCT to Evaluate E-Cigarette Prevention Program: CATCH My Breath
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: E-cigarette Use
Keywords: E-cigarette Prevention
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-04-13
Enrollment: 1790
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of students who currently use e-cigarettes
timeFrame: baseline
measure: Number of students who currently use e-cigarettes
timeFrame: 3 years
measure: Number of students who have ever used e-cigarettes in their lifetime
timeFrame: baseline
measure: Number of students who have ever used e-cigarettes in their lifetime
timeFrame: 3 years
measure: Number of students who are susceptible to e-cigarette use
timeFrame: baseline
measure: Number of students who are susceptible to e-cigarette use
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas Health Science Center at Houston School of Public Health at Austin
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Steven H Kelder, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: