Journey of Transformation Curriculum for Native American Adolescents (JOT)

September 14, 2023 updated by: Teresa Evans-Campbell, University of Washington

Discovering Our Story, to Develop the Journey of Transformation

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.

Study Overview

Detailed Description

This study assesses a new curriculum that will be available to students in the ninth 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. Take a 30-40 minute online survey about healthy relationships, drug use, youth leadership skills and connecting with Native communities.

Weeks 1-3. Meet with a counselor 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 - 8 (months 1-2). As part of the health class, attend about 16 health sessions on healthy behaviors and health promotion. Learn new skills around youth leadership, storytelling, and traditional health practices. The sessions will highlight connecting to tribal traditions.

Month 3. Take an online check-in survey via a link sent to participants' email address.

Month 6. Take an online check-in survey via a link sent to participants' email address.

Month 12. Take an online check-in survey via a link sent to participants' email address.

Optional after school activities Week 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 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 counselor for a session to revise goals for health and community leadership.

Week 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. The story can be about what has been learned about health promotion, traditional health practices, and to celebrate participants' health leadership journey.

Week 25 (month 6). Attend the leadership night and present digital stories.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Between 13 years of age and 16 years of age
  • Attending an off-reservation boarding school in the ninth grade at time of enrollment

Exclusion Criteria:

  • Under 13 years old, or over 16 years old
  • Does not attend an off-reservation boarding school in the ninth grade at time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate group
Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.
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.
Experimental: Waitlist group
Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patterns of 30 Day Substance Use Assessed by Self-report
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)
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)
Change in Sexual Behavior Assessed by the Adolescent Sexual Activity Index (ASAI)
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)
The Adolescent Sexual Activity Index (ASAI) is a 13-item index which assesses pre-coitus sexual behaviors and produces an 11-point scale from 0-10 (Hansen et al., 1999).
Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) Measure
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)
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)
Change in the Health Belief Model-Intentions for Safer Sex Intentions (HBMI) (Lux & Petosa, 1994)
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)
7 items will be used to predict safer sex intentions on a 5-point Likert scale (strongly agree to strongly disagree, where 1 is strongly agree).
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])
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Teresa A Evans-Campbell, MSW, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

September 21, 2022

Study Completion (Actual)

September 21, 2022

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00012676
  • 1R01DA050521-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only de-identified individual participant data (IPD) will be available after Institutional Review Board (IRB) and agency approval.

IPD Sharing 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.

IPD Sharing Access Criteria

Contact PI for access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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