- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05274217
Journey of Transformation Curriculum for Native American Adolescents (JOT)
Discovering Our Story, to Develop the Journey of Transformation
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98105
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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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.
|
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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).
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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.
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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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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).
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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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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)
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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.
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Teresa A Evans-Campbell, MSW, PhD, University of Washington
Publications and helpful links
General Publications
- 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.
- Hansen WB, Paskett ED, Carter LJ. The Adolescent Sexual Activity Index (ASAI): a standardized strategy for measuring interpersonal heterosexual behaviors among youth. Health Educ Res. 1999 Aug;14(4):485-90. doi: 10.1093/her/14.4.485.
- 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
- 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.
- Petosa R, Jackson K. Using the health belief model to predict safer sex intentions among adolescents. Health Educ Q. 1991 Winter;18(4):463-76. doi: 10.1177/109019819101800405.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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