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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-14
SponsorUniversity of Hawaii

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

6th-8th grade students attending a public or public-charter school on Hawaii Island.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: ENDS Prevention InterventionExperimental treatment 1 intervention
Group B: Treatment-as-usual controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recent Electronic Nicotine Delivery System (ENDS) use

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

Time frame
Up to 19 months

Secondary outcomes

1

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

Past 30-day alcohol, tobacco, and other drug use

Time frame
Up to 19 months

Other outcomes

Sponsors and contacts

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University of Hawaii

Lead sponsor

University of California, Riverside

Collaborator