Journey of Transformation Curriculum for Native American Adolescents

NCT05274217 | Terminated Results DMC

• 2 other identifiers: STUDY000126761R01DA050521-01A1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use; Tobacco Use; Substance Use; Sexual Health

Keywords

Native American; American Indian; Adolescents

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 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 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 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 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 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.

Immediate group; Waitlist group

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Between 13 years of age and 16 years of age
• Attending an off-reservation boarding school in the ninth grade at time of enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (5)

• 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

• 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.

  PMID: 10557519 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

  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: 15648887 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.

  PMID: 1757268 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking; Tobacco Use; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Early termination of trial led to no post outcomes. No subjects were analyzed.

Results Point of Contact

• Title: Teresa Evans-Campbell
• Organization: University of Washington

tecamp@uw.edu

206-543-6075

Study Officials

• Teresa A Evans-Campbell, MSW, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: School of Social Work

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: September 13, 2022
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: October 4, 2023
• Results First Posted: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• 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)