NCT06929520 The Development and Evaluation of a Culturally Grounded ENDS Intervention for Rural Hawaiian Youth
| NCT ID | NCT06929520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Hawaii |
| Condition | E-cigarette Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2025-10-15 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 6th-8th grade students attending a public or public-charter school on Hawaii Island. Exclusion Criteria: * K-5th grade students and 9th-12th grade students on Hawaii Island.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06929520 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 14 Years, studying E-cigarette Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06929520 currently recruiting?
Yes, NCT06929520 is actively recruiting participants. Contact the research team at okamotos@hawaii.edu for enrollment information.
Where is the NCT06929520 trial being conducted?
This trial is being conducted at Honolulu, United States.
Who is sponsoring the NCT06929520 clinical trial?
NCT06929520 is sponsored by University of Hawaii. The trial plans to enroll 500 participants.