The Hastiin Bidziil (Strong Man) Intervention

The Hastiin Bidziil (Strong Man) Intervention: A Study to Measure the Effectiveness of a Secondary Prevention Program Aimed at Reducing Substance Use Among Adult Native Men

The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths & Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18 years and older

Study Overview

• Status: Recruiting
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Hastiin Bidziil; Other: Control condition - vehicle maintenance

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyann Dedman-Cisco, MPH; Phone Number: 928-674-6824; Email: kdedman1@jhu.edu
• Study Contact Backup: Name: Marissa Begay, MA; Phone Number: 928-674-6824; Email: mbegay5@jhu.edu

Study Locations

• United States
  • Arizona
    • Chinle, Arizona, United States, 86503
      • Recruiting
      • Navajo Nation Center for Indigenous Health - Chinle
      • Contact: Kyann Dedman-Cisco, MPH; Phone Number: 928-674-6824
    • Fort Defiance, Arizona, United States, 86504
      • Recruiting
      • Navajo Nation Center for Indigenous Health - Fort Defiance
      • Contact: Kyann Dedman-Cisco, MPH; Phone Number: 928-729-2435

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-identify as American Indian
• Self-identify as a man
• Age 18 years or older at time of enrollment
• Screen positive for lifetime use of alcohol and/or drugs, except for tobacco use only
• Reside within ~60 miles of a study community (Fort Defiance, AZ; Chinle, AZ)

Exclusion Criteria:

• Any condition that would affect successful participation (e.g., planned move)
• Profound disability that limits the ability to participate in assessments or interventions
• Participated in the preliminary phase of this study to adapt CETA for this project

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Active Control Group - Vehicle Maintenance; Control condition was selected by the Community Research Council and includes five sessions on basic vehicle maintenance.	Other: Control condition - vehicle maintenance; Control condition was selected by the Community Research Council and includes five sessions on basic vehicle maintenance such as changing tire, checking fluid levels, and winterizing vehicles.
Experimental: Hastiin Bidziil (Strong Man) intervention; CETA intervention adapted for AI men ages 18 and older. Adaptation will take place leading up to implementation of the randomized controlled trial	Behavioral: Hastiin Bidziil; Common Elements Treatment Approach (CETA) modified for cultural and gendered specific delivery for maximum community impact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days of substance sse as assessed by Time Line Follow-back	Number of days of substance use over the previous month measured at 8-months post baseline using Timeline Follow-Back (TLFB)	8-months post baseline

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Jennifer Richards, PhD, Johns Hopkins University; Principal Investigator: Jerreed D Ivanich, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Common Elements Treatment Approach (CETA); Young Men
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: IRB00027710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No