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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA050521-01A1 | U.S. NIH Grant/Contract | View source |
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Significant revision of protocol inspired by site staff changes and site COVID delays
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate group | Experimental | Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester. |
|
| Waitlist group | Experimental | Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Journey of Transformation-Native Youth Health Leadership Program curriculum | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa A Evans-Campbell, MSW, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 10557519 | Background | 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. | |
| Background | 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 | ||
| 15648887 |
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Only de-identified individual participant data (IPD) will be available after Institutional Review Board (IRB) and agency approval.
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.
Contact PI for access.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Group | Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester. 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. |
| FG001 | Waitlist Group | Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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This study was terminated due to a significant revision of protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Group | Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected. | Posted | Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only) |
|
1 month
We used the clinicaltrials.gov definitions of "adverse event" and "serious adverse event."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Group | Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester. 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. |
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Early termination of trial led to no post outcomes. No subjects were analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Evans-Campbell | University of Washington | 206-543-6075 | tecamp@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2021 | Sep 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2021 | May 31, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent Form | Sep 7, 2022 | May 31, 2023 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent / Guardian Permission Form | Feb 8, 2023 | Sep 14, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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A randomized waitlist stepped wedge design with study participants recruited in staggered cohorts, with those in each annual recruitment wave receiving individual-level random assignment to either immediate intervention or waitlist control.
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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) |
| 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) |
| 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) |
| 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. |
| 1757268 | Background | 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. |
| BG001 | Waitlist Group | Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Waitlist Group | Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester. 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. |
|
| 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). | Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected. | Posted | 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. | Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected. | Posted | 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. | Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected. | Posted | 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). | Outcome data is not available due to study termination at baseline. Therefore, post-intervention and follow-up data were not collected. | Posted | Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only) |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Waitlist Group | Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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