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

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
University of Hawaii
Study ID
NCT06929520
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

  • ENDS Prevention Intervention (TBD) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
May 2026
Primary completion
May 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIP
University of HawaiiHonoluluHawaii96813

Find similar trials in Honolulu, HI

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Hawaii· Honolulu, HI

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