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

NCT06929520 | Not Yet Recruiting

• 1 other identifier: R01DA054215
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recent Electronic Nicotine Delivery System (ENDS) use

  Past 30-day use of e-cigarettes and/or vaping devices

  Up to 19 months

Secondary Outcomes (1)

• Recent Alcohol, Tobacco, and Other Drug (ATOD) use

  Up to 19 months

Study Arms (2)

ENDS Prevention Intervention

EXPERIMENTAL

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

Behavioral: ENDS Prevention Intervention (TBD)

Treatment-as-usual control

NO INTERVENTION

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

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.

ENDS Prevention Intervention

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• th-8th grade students attending a public or public-charter school on Hawaii Island.

You may not qualify if:

• K-5th grade students and 9th-12th grade students on Hawaii Island.

Sponsors & Collaborators

• University of Hawaii: lead
• University of California, Riverside: collaborator

Study Sites (1)

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Vaping; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Smoking; Behavior; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Scott K Okamoto, PhD

CONTACT

808-356-5775; okamotos@hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dynamic wait-listed control group design

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 16, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)