JOT: Journey of Transformation

Sponsor
University of Washington (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05274217
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), Elderberry Wisdom Farm (Other)
360
1
2
42.1
8.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Journey of Transformation-Native Youth Health Leadership Program curriculum
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Discovering Our Story, to Develop the Journey of Transformation
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Experimental: Waitlist group

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in patterns of 30 day substance use assessed by self-report [Baseline to 3 month (post-intervention) follow-up; Baseline to 6 month follow-up; Baseline to 8 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.

  2. Change in sexual behavior assessed by the Adolescent Sexual Activity Index (ASAI) [Baseline to 3 month (post-intervention) follow-up; Baseline to 6 month follow-up; Baseline to 8 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).

Secondary Outcome Measures

  1. 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 8 month follow-up; Baseline to 12-month follow-up (immediate group only)]

    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.

  2. 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 8 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.

  3. Change in the Health Belief Model-Intentions for Safer Sex Intentions (HBMI) (Lux & Petosa, 1994) [Baseline to 3 month (post-intervention) follow-up; Baseline to 6 month follow-up; Baseline to 8 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98105

Sponsors and Collaborators

  • University of Washington
  • National Institute on Drug Abuse (NIDA)
  • Elderberry Wisdom Farm

Investigators

  • Principal Investigator: Teresa A Evans-Campbell, MSW, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Teresa Evans-Campbell, Associate Professor: School of Social Work, University of Washington
ClinicalTrials.gov Identifier:
NCT05274217
Other Study ID Numbers:
  • STUDY00012676
  • 1R01DA050521-01A1
First Posted:
Mar 10, 2022
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Teresa Evans-Campbell, Associate Professor: School of Social Work, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022