The Development and Evaluation of a Culturally Grounded ENDS Intervention for Rural Hawaiian Youth
University of Hawaii · with University of California, Riverside · NCT06929520
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 10–14 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 500
- US sites recruiting
- 1
- Study start
- October 15, 2025
- Record last updated
- June 5, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ENDS Prevention Intervention (TBD)
Conditions: E-cigarette Use; Substance Use
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
University of Hawaii
Honolulu, HI 96813
Site contact: Scott K Okamoto, PhD · (808) 356-5775 · okamotos@hawaii.edu
Study contacts (from the official record)
- Scott K Okamoto, PhD · 808-356-5775 · okamotos@hawaii.edu