ENDS Prevention for E-Cigarette Use
Trial Summary
What is the purpose of this trial?
The purpose of this research proposal is to develop and evaluate a culturally grounded, ENDS prevention intervention for rural Hawaiian youth. This will be accomplished through two specific aims. AIM 1 (Years 1-3) are focused on pre-intervention and intervention development. In Year 1, youth focus groups will be conducted to assess the environmental demands related to ENDS use in rural Hawai'i. In Year 2, specific ENDS-related problem situations (i.e., situations that increase risk for ENDS use) will be extracted from the Year 1 focus groups and prioritized through survey methods with 200-250 predominately Native Hawaiian youth across 16 different middle/intermediate schools on Hawai'i Island. In Year 3, five situations found to be the most frequently experienced and/or difficult to manage by youth surveyed in Year 2 will serve as the foundation for the development of narrative scripts. Three of these scripts will be cast and filmed on location on Hawai'i Island by a professional film director, and will be edited into three short films, 6-8 video clips, and 6-8 professional photos or production stills. Similar to the investigators' prior drug prevention research in rural Hawai'i, classroom-based lessons will be created to support the short films. Additional lessons and videos from an evidence-based, culturally grounded substance abuse prevention curriculum for Hawaiian youth (Ho'ouna Pono) will be used to create a modular classroom curriculum. The video clips and professional photography/production stills will be embedded with prevention messaging, and will be used for a social and print media campaign to reinforce the classroom curriculum. AIM 2 (Years 4-5) is to evaluate the ENDS prevention intervention (classroom curriculum plus social/print media campaign) across all middle/intermediate public or public-charter schools (N = 16) and up to 11 different cultural immersion charter schools on Hawai'i Island using a dynamic wait-listed control group design.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the ENDS Prevention Intervention treatment?
The research highlights that many users of electronic nicotine delivery systems (ENDS) are interested in quitting, with over 10% attempting to quit in the past year and 60% planning to quit in the future. This suggests that interventions aimed at preventing or reducing ENDS use could be effective, as there is a significant interest in cessation among users.12345
Is the ENDS Prevention Intervention generally safe for humans?
The safety of electronic nicotine delivery systems (ENDS) is still being studied, and there are concerns about their potential harmful effects, especially for young people and pregnant women. While some believe ENDS might help reduce smoking risks, definitive safety data is lacking, and more research is needed to understand their health impacts.13678
How is the ENDS Prevention Intervention treatment different from other treatments for e-cigarette use?
The ENDS Prevention Intervention is unique because it focuses on preventing the use of electronic nicotine delivery systems (e-cigarettes) rather than treating existing use, which is a novel approach compared to other treatments that typically address cessation. This intervention is particularly important as it targets young people and non-smokers who are increasingly using e-cigarettes, a group for whom these products were not originally intended.1391011
Eligibility Criteria
This trial is for rural Hawaiian youth, primarily Native Hawaiian, who are attending middle or intermediate schools on Hawai'i Island. It aims to prevent the use of electronic nicotine delivery systems (ENDS), commonly known as e-cigarettes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-intervention and Intervention Development
Focus groups and surveys are conducted to develop and prioritize ENDS-related problem situations and create narrative scripts and classroom lessons.
Efficacy Trial
The ENDS prevention intervention is evaluated using a dynamic wait-listed control group design across participating schools.
Follow-up
Participants are monitored for the effectiveness of the intervention with follow-up evaluations at various intervals post-intervention.
Treatment Details
Interventions
- ENDS Prevention Intervention
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Who Is Running the Clinical Trial?
University of Hawaii
Lead Sponsor
University of California, Riverside
Collaborator