An interventional study of Journey of Transformation-Native Youth Health Leadership Program curriculum in Alcohol Drinking, Tobacco Use and Substance Use, sponsored by University of Washington. Active, not recruiting at 1 site in United States. Open to participants aged 13 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
The investigators will conduct a waitlist control trial to test the efficacy of the Journey of Transformation-Native Youth Health Leadership Program (JOT) in terms of delaying or reducing tobacco and other substance use and improving sexual health.
This study assesses a new curriculum that will be available to students in the tenth grade. The lessons will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making, field trips), as well as Traditional Ecological Knowledge (TEK) activities. This study also assesses how well the curriculum explains leadership skills, Native American cultural arts, the natural environment, and promotes healthy decision-making around health and relationships.
Participants are assigned to a health class that starts the curriculum in the fall or to a health class that will start the curriculum in the winter. Participants will:
Week 1. Complete a 15-20- minute online survey about healthy relationships, drug use, youth leadership skills, and connecting with Native communities.
Weeks 1 - 3. Meet with a study educator up to two times to set goals around health, healthy relationships and how to reduce or avoid alcohol, tobacco, or other drug use.
Weeks 1 - 12 (months 1-3). As part of the class, attend up to ten health sessions on healthy behaviors and health promotion. Learn new skills around youth leadership, storytelling, and traditional health practices. The sessions will highlight connection to tribal traditions.
Month 3. Complete an online check-in survey via a link sent to participants' email address.
Month 6. Complete an online check-in survey via a link sent to participants' email address.
Month 12. Complete an online check-in survey via a link sent to participants' email address.
Optional after school activities:
Weeks 9 - 16 (months 3-4). Attend a once-a-month activity to help build leadership skills. Activities are between 1-2 hours after school and include drum making, film making, creating a storytelling vest that incorporates their own cultural symbols, and up to two outdoor field trips. The field trips are to places of cultural significance near the school and involve a 30-45 minute hike.
Week 16 (month 4). Meet with the study educator for a session to revise goals for health and community leadership.
Weeks 9 - 24 (months 3-6). Attend a 2-hour digital storytelling training and three monthly planning sessions to prepare for an optional digital storytelling leadership night. Stories can be about what participants have learned about health promotion, traditional health practices, and to celebrate their health leadership journey.
Week 25 (month 6). Attend the leadership night and present digital stories if participants would like. Help prepare a traditional feast and giveaway that will honor community culture and values.
420 studies on the registry are indexed under Tobacco Use; 82 are open to participants now.
This study's enrollment of 182 is above the median of 124 across 351 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Compared within Tobacco Use, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.
Behavioral: Journey of Transformation-Native Youth Health Leadership Program curriculum
Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.
Behavioral: Journey of Transformation-Native Youth Health Leadership Program curriculum
Curriculum activities will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making), as well as Traditional Ecological Knowledge (TEK) activities and field trips. Curriculum content explains leadership skills and promotes healthy decision-making around substance use and sexual health.
Change in patterns of 30 day substance use assessed by self-report
Patterns of substance use (Monitoring the Future \[MTF\] 30-day self-report assessed on an ordinal scale \[0 occasions, 1-2 occasions, 3-5 occasions, 6-9 occasions, 10-19 occasions, 20-39 occasions, 40 or more occasions\]). Substances include tobacco, alcohol, marijuana, stimulants, inhalants, opioids, and other drugs.
Time frame: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Change in sexual behavior assessed by self-report
Primary sexual behaviors assessed by items from the Adolescent Sexual Activity Index
Time frame: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Change in intentions to use alcohol, cigarettes, and marijuana in the next year (assessed by Monitoring the Future [MTF])
Assess intention to use alcohol, cigarettes, and marijuana in the next year (3 items) on a 5-point scale (I have already tried \[substance\], I definitely will, I probably will, I probably will not, I definitely will not). Scores are summed and standardized on a scale of 0 to 100 percent.
Time frame: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Change in the Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) Measure
The Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) measure captures the perceived likelihood that youth will use drugs and alcohol in specific situations on a 3-point scale (Yes, No, Unsure). Higher scores reflect higher perceived ability to refuse alcohol or drugs.
Time frame: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Change in the Sexual Health and Reproductive Empowerment for Young Adults Scale (self-efficacy) (Upadhyay et al., 2020)
23 items will be used to assess young people's empowerment regarding sexual and reproductive health on a 5-point Likert scale (Not at all true to Extremely true).
Time frame: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Plan to share: Yes — Only de-identified IPD will be available after institutional IRB and agency approval.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: De-identified data will be available for 12 months after publication of the main findings manuscript. Other resources, such as training materials and the curriculum, will be available after demonstration of their efficacy.
Access criteria: Contact PI for access.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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