Tobacco Smoking Clinical Trial
Official title:
University of Guam/University of Hawaii Cancer Center Partnership for Cancer Health Equity, Full Project I: Developing and Testing a School-Based Curriculum for E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention for Guam Youths
Verified date | February 2024 |
Source | University of Guam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The people of the U.S. Affiliated Pacific Islands (USAPI) face higher cancer incidence, especially lung/bronchia and head-and-neck cancer, and poorer cancer outcomes, compared with the U.S. nationally. This may partly be driven by the high rates of cigarette smoking and betel (areca) nut use in the USAPI. Previous data suggest that that adolescents on Guam, as young as middle school students report markedly higher e-cigarette and tobacco product use prevalence in the USAPI compared with the USAPI nationally. Guam youths are also at risk for the use of betel nuts. Yet, currently there are no tobacco product/areca nut use prevention programs that have been developed for and tested specifically USAPI adolescents. The proposed study will develop a school-based substance use prevention curriculum for e-cigarette, tobacco product, and areca nut use prevention among Guam youths. The curriculum will use lessons incorporating innovative videos and culturally grounded activities. The study's specific aims are: 1. To develop a school-based curriculum for e-cigarette, tobacco product (i.e., cigarette, smokeless tobacco), and betel nut use prevention among middle school students in Guam. 2. Test the efficacy of the school-based curriculum in a randomized controlled trial.
Status | Completed |
Enrollment | 534 |
Est. completion date | August 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 15 Years |
Eligibility | Inclusion Criteria: - All students enrolled in public middle schools in Guam (age: 11-15 years old) - Provide signed parental informed consent and student assent Exclusion Criteria: - Participants whose parents decline participation or students who decline participation. |
Country | Name | City | State |
---|---|---|---|
Guam | Guam Department of Education | Tiyan |
Lead Sponsor | Collaborator |
---|---|
University of Guam | National Cancer Institute (NCI), University of Hawaii Cancer Research Center |
Guam,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Youth Risk Behavior Surveillance (YRBS) Survey-based self-reported past-30-day tobacco, e-cigarette, and areca nut use | Tobacco, e-cigarette, and areca nut use behavior will be assessed using a standardized self-report measure of recent use that is use in the national YRBS survey. The questionnaire item will ask: "In the past 30 days, on how many days did you smoke a cigarette?" This question will be adapted for e-cigarette and areca nut. Response options include: "0 days," "1-2 days," "3-5 days," "6-9 days," "10-19 days," "20-29 days," "all 30 days." | Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up) | |
Primary | Changes in Pierce's Smoking Susceptibility Scale (also adapted for e-cigarette and areca nut use) | This is a standardized self-report measure containing 4 items originally designed to assess smoking susceptibility among adolescents. In addition to the original measure, the current study will also adapt the measure to assess e-cigarette and areca nut use susceptibility. The 4 items are: "Do you think you will smoke a cigarette soon?", "Do you think you will smoke a cigarette in the next year?", "Do you think in the future you might experiment with cigarettes?", "If one of you friends were to offer you a cigarette, would you smoke it?" | Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up) | |
Secondary | Kendall Wilcox Self-control Scale | This is a standardized self-report scale containing 7 items designed to assess generalized self-control, including impulsivity and behavioral self-control. | Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up) | |
Secondary | Jackson et al.'s Social Competence Scale | This is a standardized self-report scale containing 27 items designed to assess social competence is resisting social influence related to tobacco and other substance use among adolescents. | Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up) | |
Secondary | Sherer et al.'s General Self-Efficacy Scale | This is a standardized self-report scale containing 6 items designed to assess confidence in performing a behavior. Sample items include "When I make plans, I am certain I can make them work", "If I can't do a job the first time, I keep trying until I can", and "When I have something unpleasant to do, I stick to it until I finish it". | Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up) | |
Secondary | Flay et al.'s Refusal Self-Efficacy | This is a standardized self-report scale containing 6 items designed to assess confidence in refusing tobacco and other substance use offers. | Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up) |
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