Clinical trial NCT04267692: Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders
Official title: Development and Evaluation of Harm Reduction Talking Circles for Urban American Indians and Alaska Natives With Alcohol Use Disorders - Phase III Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Indigenous Medicine
American Indian
Alaska Native
alcohol use disorder
alcohol treatment
treatment efficacy
quality of life
cultural connectedness
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2020-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Alcohol frequency
timeFrame: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
measure: Change in Peak alcohol use
timeFrame: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
measure: Change in Alcohol-related harm
timeFrame: Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
measure: Change in EuroQoL-5 Dimensional-5 Level
timeFrame: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
measure: Change in Cost effectiveness
timeFrame: 6 months before study participation compared to 6 months after enrollment.
measure: Change in Ethyl glucuronide
timeFrame: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Secondary outcomes:
Other outcomes:
measure: Change in Cultural connectedness
timeFrame: Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.
Locations:
city: Seattle
country: United States
facility: Seattle Indian Health Board
state: Washington
Study officials:
affiliation: Washington State University
name: Lonnie A Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: