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E-cigarette UseNCT06929520

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

A study testing ENDS Prevention Intervention (TBD) in people with E-cigarette Use and Substance Use, run by University of Hawaii at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 14 yearsHealthy volunteers can take part
Conditions the study is for
E-cigarette Use, Substance Use
What is being tested?
ENDS Prevention Intervention (TBD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
15 Oct 2025to 15 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Scott K Okamoto, PhD contact

808-356-5775

okamotos@hawaii.edu

United States1 site, 1 recruiting
  • University of Hawaii

    Honolulu, Hawaii, 96813

    Scott K Okamoto, PhD, (808) 356-5775, okamotos@hawaii.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Assessing Environmental Demands (Year 1). A qualitative design using focus groups and follow-up in-depth interviews will be used to examine the social, cultural, and developmental context of youth ENDS and dual use in rural Hawai'i. Ten to fifteen youth focus groups (3-5 members per group) will be conducted to identify problematic social situations involving offers to use ENDS (with or without combustible cigarettes) from peers, cousins, and adult family members. Participants will be asked to describe social situations where they encountered ENDS (with or without combustible cigarettes) being offered to them or where there was an implicit demand to use these substances. A convenience sample of Native Hawaiian youth participants will be recruited from at least sixteen rural public middle, intermediate, or multi-level schools on Hawai'i Island. Focus groups will be gender-specific, and group facilitators will match the gender of the groups.

Situation Identification and Prioritization (Year 2). The goal of this step is to operationalize and prioritize problematic social situations involving ENDS and dual use, by assessing them for their frequency of exposure and perceived difficulty for refusal. Fifty to one-hundred twenty-five potential items will be drawn from the focus group and interview data in Year 1, which will be reduced in number through expert analysis, and then be subjected to an assessment of social validity. The latter step entails youth participants rating each item on two criteria using Likert scales: (1) the frequency with which the subject encountered the situation (from never to more than 4 times per month), and (2) the perceived difficulty in dealing with the situation (from very easy to very difficult). The survey will be administered to 200-250 predominantly Native Hawaiian and Pacific Islander adolescents on Hawai'i Island. Descriptive statistics will be used to examine the prevalence of situations and their perceived difficulty. Exploratory factor analytic procedures will be used to establish subscales, and construct validity will be assessed by examining the relationship of the items to the use of ENDS and combustible cigarettes. Five of the most frequently experienced and/or challenging situations identified by surveyed youth will be translated into narrative scripts by a professional scriptwriter/videographer (Yamashita) in Year 3.

Video Production (Year 3). In this phase, five frequently experienced and difficult ENDS-related problem situations and youth-identified strategies to deal with them will be translated to a scripted format by an Emmy award-winning scriptwriter/videographer (Matt Yamashita). These scripts will evolve from situations prioritized in Year 2, but based on the research literature, we anticipate that they will focus on the use of ENDS e-liquid flavors, marijuana vaping, and/or dual use (ENDS and combustible cigarette use). Three of the five scripts will be cast, filmed on location on Hawai'i Island, and edited into three 5-7 minute videos. Each will depict a main storyline, and three different endings demonstrating refusal strategies of varying levels of competence. This phase will not entail human subjects.

Lesson and Social/Print Media Development (Year 3). In this phase, three new ENDS prevention lessons will be developed that are focused on the videos, and will be delivered with 4 of 7 ATOD lessons developed and evaluated in the Ho'ouna Pono efficacy trial (R01 DA037836). These will be delivered as part of a modular prevention intervention, where teachers will be able to select the four Ho'ouna Pono lessons to accompany the three ENDS-focused lessons, in order to customize the curriculum to fit their students' needs. Social media components (i.e., short video clips with embedded ENDS prevention messaging) and print media components (i.e., poster-sized still images with embedded ENDS prevention messaging) will also be created. The three ENDS prevention lessons and social/print media components will be validated by a sample of Native Hawaiian youth (n = 10-15) and educational stakeholders (n = 10-15). The classroom lessons will be delivered by teachers in participating schools as part of the health curriculum, while the social and print media components will be delivered concurrently with the classroom-based curriculum. The social media components will be delivered through popular social media platforms (Instagram, Snapchat, and/or TikTok) using school-supervised accounts, while the print media components will be posted on bulletin and message boards throughout schools receiving the intervention.

Efficacy Trial (Years 4-5). A dynamic wait-listed control group design will be employed to examine the longitudinal effects of the ENDS intervention (i.e., modular prevention curriculum and social/print media campaign). All participating schools will be block randomized based on region (north, south, east, and west Hawai'i) into four cohorts, and cohorts will be randomly assigned to receive the intervention at designated times staggered across the two-year evaluation period. Schools in Cohorts 1 and 2 will receive the intervention in Year 4 of the study, while schools in Cohorts 3 and 4 will receive the intervention in Year 5. As a result, all schools will be evaluated at pre-test and immediate post-test, and schools in Cohorts 1-3 will receive follow up evaluations. Schools in Cohort 1 will receive follow ups at 3-, 9-, 12-, and 15-months post-intervention, Cohort 2 at 6-, 9-, and 12-months post-intervention, and Cohort 3 at 3-months post-intervention. In terms of measurement, the survey used to evaluate the efficacy of the ENDS prevention intervention will include standard demographic items covering areas such as age, grade, gender, family structure, and SES, as well as 52 items related to culture/enculturation, risk and protective factors (including ENDS and combustible cigarette use frequency), resistance strategies, risk assessment, and peer affiliations. Main effects related to ENDS and dual use will be measured, as well as the use of different resistance strategies depicted in the videos. Peer affiliations over time will also be measured to examine the effect of the intervention on the social and relational context of youth in rural Hawai'i.

Being tested
ENDS Prevention Intervention (TBD)
Medical subject headings
Vaping, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENDS Prevention Intervention (TBD)Behavioural

    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 groups in NCT06929520
Study groupRoleWhat they receive
ENDS Prevention InterventionExperimentalParticipants will receive the ENDS Prevention Intervention consisting of (1) a modular classroom curriculum, (2) social media content, and (3) print media campaign.
Receives: Behavioral: ENDS Prevention Intervention (TBD)
Treatment-as-usual controlNo interventionParticipants will receive treatment-as-usual, which consists of the standard health curriculum delivered in public schools.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recent Electronic Nicotine Delivery System (ENDS) use

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

    Measured: Up to 19 months

Secondary outcomes (1)
  1. Recent Alcohol, Tobacco, and Other Drug (ATOD) use

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

    Measured: Up to 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2025
  2. Study start15 Oct 2025
  3. Primary completion15 May 2027 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
Dynamic wait-listed control group design
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06929520
Sponsor's protocol ID
R01DA054215
Status last verified
May 2026
First submitted
7 Apr 2025
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data, consistent with the NIH Data Safety and Monitoring plan for this study, will be shared with other researchers upon request.

Questions about this trial

What is this clinical trial studying?

A study testing ENDS Prevention Intervention (TBD) in people with E-cigarette Use and Substance Use, run by University of Hawaii at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Scott K Okamoto, PhD (808-356-5775, okamotos@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recent Electronic Nicotine Delivery System (ENDS) use (time frame: Up to 19 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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