NCT05731713

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Dec 2023Feb 2027

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

December 11, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

February 7, 2023

Last Update Submit

April 15, 2026

Conditions

Alcohol DrinkingTobacco UseSubstance UseSexual Behavior

Keywords

Native AmericanAmerican IndianAdolescents

Outcome Measures

Primary Outcomes (2)

  • 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 self-report

    Primary sexual behaviors assessed by items from the Adolescent Sexual Activity Index

    Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)

Secondary Outcomes (3)

  • Change in intentions to use alcohol, cigarettes, and marijuana in the next year (assessed by Monitoring the Future [MTF])

    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

    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 Sexual Health and Reproductive Empowerment for Young Adults Scale (self-efficacy) (Upadhyay et al., 2020)

    Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)

Study Arms (2)

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.

Behavioral: Journey of Transformation-Native Youth Health Leadership Program curriculum

Waitlist group

EXPERIMENTAL

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

Behavioral: Journey of Transformation-Native Youth Health Leadership Program curriculum

Interventions

Journey of Transformation-Native Youth Health Leadership Program curriculumBEHAVIORAL

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.

Immediate groupWaitlist group

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attends an off-reservation boarding school in the tenth grade at time of enrollment

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (4)

  • 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

    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.

    PMID: 15648887BACKGROUND

  • 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.

    PMID: 32690468BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Alcohol DrinkingTobacco UseSubstance-Related DisordersSexual Behavior

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Teresa A Evans-Campbell, MSW, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: A stepped-wedge clinical trial with study participants recruited in staggered cohorts, with those in each annual recruitment wave receiving individual-level assignment to either immediate intervention or waitlist control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor: School of Social Work

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 16, 2023

Study Start

December 11, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Only de-identified IPD will be available after institutional IRB and agency approval.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
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.
Access Criteria
Contact PI for access.

Locations

US(1)