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

NCT04267692 | Unknown DMC

• 2 other identifiers: P60AA026112-RP2P60AA026112
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Indigenous Medicine; American Indian; Alaska Native; alcohol use disorder; alcohol treatment; treatment efficacy; quality of life; cultural connectedness

Outcome Measures

Primary Outcomes (6)

• Change in Alcohol frequency

  Alcohol and Substance Use Frequency Assessment items were adapted from the Addiction Severity Index-Fifth Edition (ASI-5th Ed) and will be used to assess frequency of alcohol use in the past 30 days. Scores range from 0 to 30 with higher scores indicating more frequent drinking.

  Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

• Change in Peak alcohol use

  The Alcohol Quantity and Use Assessment was created by the research team for previous studies with a similar population and will be used to record the quantity of alcohol consumed on participants' heaviest, typical, and lightest drinking days in the past month. Scores are expressed in number of standard drinks with higher numbers indicating heavier drinking.

  Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

• Change in Alcohol-related harm

  The Short Inventory of Problems-2nd Revision (SIP-2R), a psychometrically reliable and valid 15-item, Likert-scale questionnaire, measures social, occupational, and psychological problems related to alcohol use. Scores range from 0 to 45 with higher scores indicating more severe alcohol-related harm.

  Pre-intervention, mid-, immediate post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

• Change in EuroQoL-5 Dimensional-5 Level

  The EuroQoL-5 Dimensional-5 Level is a widely used generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). Each domain is rated on a 5 point likert scale. Scores range from 5-25, with higher scores indicating poorer health related quality of life.

  Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

• Change in Cost effectiveness

  \*\*Self-report data for cost-effectiveness analyses -The Non-Study Resources Form: documents change in medical and nonmedical resources used by participants.

  6 months before study participation compared to 6 months after enrollment.

• Change in Ethyl glucuronide

  Ethyl glucuronide (EtG) urine tests will be used to validate self-reported alcohol use at each assessment. EtG, a metabolite of ethyl alcohol formed in the body after ethanol exposure, reflects alcohol consumption over the previous 72 hours. EtG (cutoff 300 mg/nl) will serve as a secondary outcome in analyses.

  Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

Other Outcomes (1)

• Change in Cultural connectedness

  Pre-intervention, mid-, immediately post-intervention, 1 month post-intervention, 3 months post intervention, and 6 months post-intervention.

Study Arms (1)

Harm Reduction Treatment Circles (HaRTC)

EXPERIMENTAL

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

Other: HaRTC

Interventions

HaRTC 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.

Harm Reduction Treatment Circles (HaRTC)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being urban AI/AN,
• being at least 21 years of age (for legal reasons), and
• meeting criteria for a current AUD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

You may not qualify if:

• refusal or inability to consent to participation in research, and
• potential to place the safety or security of other patients or staff at risk

Sponsors & Collaborators

• Washington State University: lead
• University of Washington: collaborator

Study Sites (1)

Seattle Indian Health Board

Seattle, Washington, 98144, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lonnie A Nelson, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: February 13, 2020
• Study Start: September 28, 2020
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)