Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders

NCT ID: NCT04267692

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2023-11-30

Brief Summary

This randomized clinical trial will compare participants who receive HaRTC versus the nontreatment control arm to see if HaRTC helps urban American Indians and Alaska Natives who meet criteria for an alcohol use disorder to increase their engagement in cultural practices, enhance their quality of life, and reduce their alcohol-related harm.

Detailed Description

HaRTC refers to an alcohol treatment that integrates the traditional Native practice of Talking Circles with harm reduction, a low-barrier approach to substance-use treatment that does not require sobriety or use reduction. The HaRTC study is a collaboration between WSU, UW, and Seattle Indian Health Board (SIHB). It is funded by the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health. In this study, researchers from WSU and UW are working together with urban-dwelling community members who have Native heritage and lived experience of alcohol use disorder as well as with traditional health professionals, staff and management at SIHB. As a team, we are tailoring, implementing, and evaluating HaRTC as a culturally appropriate treatment for urban American Indians and Alaska Natives.

This study is divided into three phases:

Phase 1: During one-on-one interviews and focus groups, WSU and UW researchers asked patients, traditional healers, staff and management at SIHB how to best tailor HaRTC.

Phase 2: The researchers assembled a community action board comprised of Native community members who have lived experience as well as traditional health professionals, staff and management at SIHB to refine the HaRTC treatment manual and procedures to best fit the needs, setting and values at SIHB based on their own lived experiences and on the findings from Phase 1. This protocol was then revisited together with our community action board and community partners to ensure appropriate physical distancing in the wake of the COVID-19 pandemic. Thus, our in-person procedures were converted to a fully virtual, online protocol.

Phase 3: Researchers are conducting a randomized clinical trial of the virtual adapted Harm Reduction Treatment Circles (HaRTC) program. Participants (N=280) in the RCT will be urban American Indians and Alaska Natives. Additionally, they must be at least 21 years of age and meet criteria for a current alcohol use disorder. Participants will provide informed consent and will be randomized (like flipping a coin) to receive either HaRTC or no-treatment control so the investigators can evaluate whether HaRTC is efficacious. Participants will be asked questions about their involvement in cultural practices, alcohol use and quality of life prior to randomization, a month into the HaRTC, after the HaRTC ends, and at 1-, 3-, and 6-month follow-up interviews. It is expected that HaRTC will help patients increase their engagement with cultural traditions, enhance their quality of life, and reduce their experience of alcohol-related harm. If so, the research team will work with SIHB to make this intervention sustainable for its community members.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Harm Reduction Treatment Circles (HaRTC)

Participants will attend 8, weekly Harm Reduction Treatment Circles. We will not limit participants' access to other treatment or services.

Group Type: EXPERIMENTAL

HaRTC

Intervention Type: OTHER

HaRT-C participants will attend 8, virtual, adapted, low-barrier, weekly, closed-group Talking Circles-- named Harm Reduction Treatment Circles or HaRTC -- lasting approximately 2 hours each. During the HaRTC, the circle keeper will present the day's harm reduction topic, smudge the space, and allow participants to open themselves up to the circle. Topics presented by the Circle Keeper focus on harm-reduction and improving overall quality of health. Abstinence from alcohol use is not a requirement. We will not limit participants' access to treatment or services in either arm.

Interventions

HaRTC

HaRT-C participants will attend 8, virtual, adapted, low-barrier, weekly, closed-group Talking Circles-- named Harm Reduction Treatment Circles or HaRTC -- lasting approximately 2 hours each. During the HaRTC, the circle keeper will present the day's harm reduction topic, smudge the space, and allow participants to open themselves up to the circle. Topics presented by the Circle Keeper focus on harm-reduction and improving overall quality of health. Abstinence from alcohol use is not a requirement. We will not limit participants' access to treatment or services in either arm.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. being urban AI/AN,

2. being at least 21 years of age (for legal reasons), and

3. meeting criteria for a current AUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

Exclusion Criteria

1. refusal or inability to consent to participation in research, and

2. potential to place the safety or security of other patients or staff at risk

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Washington State University

OTHER

Sponsor Role: lead

Responsible Party

Lonnie Nelson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lonnie A Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

Seattle Indian Health Board

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P60AA026112

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P60AA026112-RP2

Identifier Type: -

Identifier Source: org_study_id