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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05731713
Other study ID # STUDY00012676-02
Secondary ID 1R01DA050521-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date December 11, 2023
Est. completion date February 28, 2027

Study information

Verified date February 2024
Source University of Washington
Contact Stephanie L Soliz, MPH
Phone 206-543-7411
Email ssoliz@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 randomly 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 255
Est. completion date February 28, 2027
Est. primary completion date February 28, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 16 Years
Eligibility Inclusion Criteria: - Attends an off-reservation boarding school in the tenth grade at time of enrollment Exclusion Criteria - None

Study Design


Intervention

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.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Belgrave FZ, Reed MC, Plybon LE, Corneille M. The impact of a culturally enhanced drug prevention program on drug and alcohol refusal efficacy among urban African American girls. J Drug Educ. 2004;34(3):267-79. doi: 10.2190/H40Y-D098-GCFA-EL74. — View Citation

Miech, Richard A., Johnston, Lloyd D., Bachman, Jerald G., O'Malley, Patrick M., Schulenberg, John E., and Patrick, Megan E. Monitoring the Future: A Continuing Study of American Youth (8th- and 10th-Grade Surveys), 2020. Inter-university Consortium for Political and Social Research [distributor], 2021-10-26. https://doi.org/10.3886/ICPSR38189.v1

National Institute on Drug Abuse, University of Michigan, Institute for Social Research. (2016). Monitoring the Future, 2016 (Combined Forms - Part B). Ann Arbor, MI: Institute for Social Research, University of Michigan.

Upadhyay UD, Danza PY, Neilands TB, Gipson JD, Brindis CD, Hindin MJ, Foster DG, Dworkin SL. Development and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults. J Adolesc Health. 2021 Jan;68(1):86-94. doi: 10.1016/j.jadohealth.2020.05.031. Epub 2020 Jul 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Primary Change in sexual behavior assessed by self-report Primary sexual behaviors assessed by items from the Adolescent Sexual Activity Index Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Secondary 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. Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Secondary 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. Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
Secondary 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). Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)
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