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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05274217
Other study ID # STUDY00012676
Secondary ID 1R01DA050521-01A
Status Terminated
Phase N/A
First received
Last updated
Start date September 13, 2022
Est. completion date September 21, 2022

Study information

Verified date September 2023
Source University of Washington
Contact n/a
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 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.


Recruitment information / eligibility

Status Terminated
Enrollment 33
Est. completion date September 21, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 16 Years
Eligibility 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 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 (5)

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

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. — 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.

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. — 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 the Adolescent Sexual Activity Index (ASAI) 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 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 Health Belief Model-Intentions for Safer Sex Intentions (HBMI) (Lux & Petosa, 1994) 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)
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