NCT06559774

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress22%
Jun 2025Mar 2029

First Submitted

Initial submission to the registry

August 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

June 18, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

August 15, 2024

Last Update Submit

April 8, 2026

Conditions

Substance Use

Keywords

Young MenCommon Elements Treatment Approach (CETA)

Outcome Measures

Primary Outcomes (1)

  • 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 6-months post baseline using Timeline Follow-Back (TLFB)

    6-months post baseline

Study Arms (2)

Hastiin Bidziil (Strong Man) intervention

EXPERIMENTAL

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

Active Control Group - Vehicle Maintenance

PLACEBO COMPARATOR

Control condition was selected by the Community Research Council and includes five sessions on basic vehicle maintenance.

Other: Control condition - vehicle maintenance

Interventions

Hastiin BidziilBEHAVIORAL

Common Elements Treatment Approach (CETA) modified for cultural and gendered specific delivery for maximum community impact

Hastiin Bidziil (Strong Man) intervention
Control condition - vehicle maintenanceOTHER

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.

Active Control Group - Vehicle Maintenance

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis is a program for people who self-identify as men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as American Indian
  • Self-identify as a man
  • Age 18 years or older at time of enrollment
  • Screen positive for at least moderate risk on any substance, except for tobacco use only
  • Reside within \~60 miles of a study community (Fort Defiance, AZ; Chinle, AZ)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Navajo Nation Center for Indigenous Health - Chinle

Chinle, Arizona, 86503, United States

RECRUITING

Navajo Nation Center for Indigenous Health - Fort Defiance

Fort Defiance, Arizona, 86504, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Jennifer Richards, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Jerreed D Ivanich, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyann Dedman-Cisco, MPH

CONTACT

928-674-6824kdedman1@jhu.edu

Marissa Begay, MA

CONTACT

928-674-6824mbegay5@jhu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The co-Leads (project Investigators) are blinded to randomization status of participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 19, 2024

Study Start

June 18, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)