The Hastiin Bidziil (Strong Man) Intervention

NCT ID: NCT06559774

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2029-03-31

Brief Summary

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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 18-26.

Detailed Description

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Conditions

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Substance Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The co-Leads (project Investigators) are blinded to randomization status of participants.

Study Groups

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Hastiin Bidziil (Strong Man) intervention

CETA intervention adapted for AI men ages 18-26. Adaptation will take place leading up to implementation of the randomized controlled trial

Group Type EXPERIMENTAL

Hastiin Bidziil

Intervention Type BEHAVIORAL

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

Active Control Group - Vehicle Maintenance

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

Group Type PLACEBO_COMPARATOR

Control condition - vehicle maintenance

Intervention Type OTHER

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.

Interventions

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Hastiin Bidziil

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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Self-identify as American Indian
* Self-identify as a man
* Age 18-26 years 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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Richards, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Jerreed D Ivanich, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Navajo Nation Center for Indigenous Health - Chinle

Chinle, Arizona, United States

Site Status RECRUITING

Navajo Nation Center for Indigenous Health - Fort Defiance

Fort Defiance, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kyann Dedman-Cisco, MPH

Role: CONTACT

928-674-6824

Marissa Begay, MA

Role: CONTACT

928-674-6824

Facility Contacts

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Kyann Dedman-Cisco, MPH

Role: primary

928-674-6824

Kyann Dedman-Cisco, MPH

Role: primary

928-729-2435

Other Identifiers

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IRB00027710

Identifier Type: -

Identifier Source: org_study_id

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