Journey of Transformation Curriculum for Native American Youth

NCT ID: NCT05731713

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2027-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Drinking Tobacco Use Substance Use Sexual Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

A stepped-wedge clinical trial with study participants recruited in staggered cohorts, with those in each annual recruitment wave receiving individual-level assignment to either immediate intervention or waitlist control.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate group

Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.

Group Type EXPERIMENTAL

Journey of Transformation-Native Youth Health Leadership Program curriculum

Intervention Type BEHAVIORAL

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.

Waitlist group

Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.

Group Type EXPERIMENTAL

Journey of Transformation-Native Youth Health Leadership Program curriculum

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Attends an off-reservation boarding school in the tenth grade at time of enrollment

Exclusion Criteria

* None
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Teresa Evans-Campbell

Associate Professor: School of Social Work

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Teresa A Evans-Campbell, MSW, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephanie L Soliz, MPH

Role: CONTACT

206-543-7411

Cynthia R Pearson, PhD

Role: CONTACT

206-330-1997

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Teresa A Evans-Campbell, MSW, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15648887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32690468 (View on PubMed)

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.

Reference Type BACKGROUND

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01DA050521-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00012676-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Trans-Led Care Study
NCT06880705 RECRUITING NA