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Recruiting NCT06559774

The Hastiin Bidziil (Strong Man) Intervention

No phase Interventional Substance Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hastiin Bidziil, Control condition - vehicle maintenance.
Who it may be relevant to
Registry conditions: Substance Use. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Behavioral Hastiin Bidziil
    Common Elements Treatment Approach (CETA) modified for cultural and gendered specific delivery for maximum community impact
  • 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.

Primary outcome measures

  • Number of days of substance sse as assessed by Time Line Follow-back [Time frame: 8-months post baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Navajo Nation Center for Indigenous Health - Chinle — Chinle
  • Navajo Nation Center for Indigenous Health - Fort Defiance — Fort Defiance

Identifiers

NCT: NCT06559774 · IRB00027710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗