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Journey of Transformation Curriculum for Native American Youth (JOT)

Primary Purpose

Alcohol Drinking, Tobacco Use, Substance Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Journey of Transformation-Native Youth Health Leadership Program curriculum
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring Native American, American Indian, Adolescents

Eligibility Criteria

13 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Attends an off-reservation boarding school in the tenth grade at time of enrollment Exclusion Criteria None

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate group

Waitlist group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Change in sexual behavior assessed by self-report
Primary sexual behaviors assessed by items from the Adolescent Sexual Activity Index

Secondary Outcome Measures

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.
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.
Change in the Sexual Health and Reproductive Empowerment for Young Adults Scale (self-efficacy) (Upadhyay et al., 2020)
23 items will be used to assess young people's empowerment regarding sexual and reproductive health on a 5-point Likert scale (Not at all true to Extremely true).

Full Information

First Posted
February 7, 2023
Last Updated
September 14, 2023
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05731713
Brief Title
Journey of Transformation Curriculum for Native American Youth
Acronym
JOT
Official Title
Discovering Our Story, to Develop the Journey of Transformation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Tobacco Use, Substance Use, Sexual Behavior
Keywords
Native American, American Indian, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate group
Arm Type
Experimental
Arm Description
Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.
Arm Title
Waitlist group
Arm Type
Experimental
Arm Description
Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.
Intervention Type
Behavioral
Intervention Name(s)
Journey of Transformation-Native Youth Health Leadership Program curriculum
Intervention Description
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 Outcome Measure Information:
Title
Change in patterns of 30 day substance use assessed by self-report
Description
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.
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)
Title
Change in sexual behavior assessed by self-report
Description
Primary sexual behaviors assessed by items from the Adolescent Sexual Activity Index
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)
Secondary Outcome Measure Information:
Title
Change in intentions to use alcohol, cigarettes, and marijuana in the next year (assessed by Monitoring the Future [MTF])
Description
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.
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)
Title
Change in the Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) Measure
Description
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.
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)
Title
Change in the Sexual Health and Reproductive Empowerment for Young Adults Scale (self-efficacy) (Upadhyay et al., 2020)
Description
23 items will be used to assess young people's empowerment regarding sexual and reproductive health on a 5-point Likert scale (Not at all true to Extremely true).
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Attends an off-reservation boarding school in the tenth grade at time of enrollment Exclusion Criteria None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie L Soliz, MPH
Phone
206-543-7411
Email
ssoliz@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia R Pearson, PhD
Phone
206-330-1997
Email
pearsonc@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa A Evans-Campbell, MSW, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa A Evans-Campbell, MSW, PhD
Email
tecamp@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Only de-identified IPD will be available after institutional 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.
Citations:
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
Results Reference
background
PubMed Identifier
15648887
Citation
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.
Results Reference
background
PubMed Identifier
32690468
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Links:
URL
https://www.askhys.net/Resources/SurveyQuestionnaires
Description
2021 Healthy Youth Survey, Form B

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Journey of Transformation Curriculum for Native American Youth

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