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E-Cigarette Prevention Program for Preventing Adolescent E-Cigarette Use

N/A

Waitlist Available

Led By Steven H Kelder, PhD, MPH

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will compare the effectiveness of an e-cigarette curriculum called the CATCH My Breath program to the usual care tobacco prevention program in delaying the onset of e-cigarette use in middle schoolers.

Who is the study for?

This trial is for middle schoolers enrolled in the 6th grade within 100 miles of the research site, who can communicate in English or Spanish. Schools must have at least 70 students per grade level and not be currently using CMB or have participated in prior pilot tests.Check my eligibility

What is being tested?

The study compares two programs to prevent e-cigarette use: 'CATCH My Breath' (CMB) program versus Texas Education Agency's required tobacco prevention program. It involves a total of 1400 students from 20 schools over three years, with schools randomly chosen for either program.See study design

What are the potential side effects?

Since this trial involves educational programs rather than medical interventions, there are no direct physical side effects expected. However, participants may experience changes in attitudes towards e-cigarettes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of students who are susceptible to e-cigarette use

Number of students who currently use e-cigarettes

Number of students who have ever used e-cigarettes in their lifetime

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CATCH My Breath (CMB) program for E-cigarette prevention among adolescentsExperimental Treatment1 Intervention

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.

Group II: Texas Education Agency required tobacco prevention programActive Control1 Intervention

The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes online lessons and support materials.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

319,187 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,931,877 Total Patients Enrolled

1 Trials studying E-Cigarette Use

40 Patients Enrolled for E-Cigarette Use

Steven H Kelder, PhD, MPHPrincipal Investigator - The University of Texas Health Science Center, Houston

The University of Texas Health Science Center, Houston

Media Library

CATCH My Breath (CMB) program for E-cigarette prevention among adolescents Clinical Trial Eligibility Overview. Trial Name: NCT04843501 — N/A

E-Cigarette Use Research Study Groups: CATCH My Breath (CMB) program for E-cigarette prevention among adolescents, Texas Education Agency required tobacco prevention program

E-Cigarette Use Clinical Trial 2023: CATCH My Breath (CMB) program for E-cigarette prevention among adolescents Highlights & Side Effects. Trial Name: NCT04843501 — N/A

CATCH My Breath (CMB) program for E-cigarette prevention among adolescents 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843501 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to register as a participant in this study currently available?

"Affirmative. Information hosted on clinicaltrials.gov reveals that this experiment, which was first made public on December 13th 2020, is currently recruiting participants. Around 2400 individuals are needed from single medical centre."

Answered by AI

Who meets the criteria necessary to participate in this research?

"This research team is recruiting 2400 minors with e-cigarette use, aged between 10 and 15. All enrolled students must be from 6th, 7th or 8th grade classes located within 100 miles of the research site."

Answered by AI

Does this clinical trial have an age restriction?

"This research trial has specified that its participants must be aged between 10 and 15. For those under the age of 18, 3 studies are available for consideration, while an additional study is open to applicants over 65."

Answered by AI

What is the total enrollment quota for this medical trial?

"Affirmative. Clinicaltrials.gov reveals that this scientific investigation is currently enrolling participants, which began on December 13th 2020 and was last amended on March 23rd 2022. 2400 volunteers from one site are needed for the trial to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Steven H. Kelder 2020. "Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04843501.