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NCT06929520

The Development and Evaluation of a Culturally Grounded ENDS Intervention for Rural Hawaiian Youth

Not yet recruiting NA Last updated 16 April 2025
What this trial tests

NA trial testing ENDS Prevention Intervention (TBD) in E-cigarette Use in 500 participants. Not yet recruiting.

Timeline
15 October 2025
Primary endpoint
15 May 2027
15 May 2027

Quick facts

Lead sponsorUniversity of Hawaii
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment500
Start date15 October 2025
Primary completion15 May 2027
Estimated completion15 May 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Hawaii

Who can join

Adults 10 to 14, any sex, with E-cigarette Use or Substance Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for E-cigarette Use

Currently open trials in the same condition.

Other University of Hawaii trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06929520.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing