Recruiting

ENDS Prevention

Sponsor:

University of Hawaii

Code:

NCT06929520

Conditions

E-cigarette Use

Substance Use

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Accepted

Interventions

ENDS Prevention Intervention (TBD)

Study Details

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.

Conditions

E-cigarette Use

Substance Use

Study ID

NCT06929520

Start date

Oct 15, 2025

Status verified date

May, 2026

Completion date

May 15, 2027

Anticipated

Primary completion date

May 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ENDS Prevention Intervention

Participants will receive the ENDS Prevention Intervention consisting of (1) a modular classroom curriculum, (2) social media content, and (3) print media campaign.

no intervention: Treatment-as-usual control

Participants will receive treatment-as-usual, which consists of the standard health curriculum delivered in public schools.

Interventions

ENDS Prevention Intervention (TBD)

The ENDS Prevention Intervention will consist of (1) a modular classroom curriculum with ENDS-focused lessons and lessons covering alcohol, tobacco, and other drug use; (2) social media content that is related to the classroom curriculum and video content, and (3) a print media campaign across school campuses on Hawaii Island.

Primary outcome measure

  • Recent Electronic Nicotine Delivery System (ENDS) use [ Time Frame: Up to 19 months ]

Central Contacts and Locations

Central contacts

Locations

University of Hawaii

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

More Information

Sponsor

University of Hawaii

Last update posted

Jun 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2026-06-05.