A Randomized Controlled Trial of Culturally Adapted Evidence-based Treatment With a Southwest Tribe

NCT05938764 | Completed

• 2 other identifiers: 06-235R01DA021672
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study combined, adapted and tested motivational interviewing (MI) and the Community Reinforcement Approach (CRA) as a culturally congruent treatment approach for Native Americans. This pilot-feasibility research was conducted in collaboration with a Southwest Tribe. The specific aims of this project were: Aim 1. To develop, in collaboration with the Tribal community, a combination of MI and CRA (MICRA) that is culturally adapted and includes a secondary focus on HIV/STD prevention; Aim 2. To develop and field test culturally-congruent research materials and procedures; Aim 3. To train Tribal behavioral health professionals in delivery of MICRA, and test (N=9) procedures for MICRA certification, supervision, and fidelity assurance; Aim 4. To conduct a pilot study (N=79) to estimate effect sizes for MICRA on key outcome variables with participants; and Aim 5. To estimate the types and prevalence of emotional distress and psychological and health problems likely to be encountered when treating substance use disorders in Native American populations. MICRA Project was conducted in two phases: Phase 1 was a feasibility (N = 9) non-randomized one-group design wherein all participants received culturally adapted MICRA. Phase 2 was a pilot (N = 79) comparing the effectiveness of MICRA and TAU. Following the screening and baseline interview, participants were randomized to receive MICRA or treatment as usual (TAU). Participants randomized to MICRA could receive up to a maximum of 16 to 20 therapy sessions with one of the MICRA counselors over the course of 16 weeks. In TAU, participants received standard outpatient services at the Tribal substance use disorder treatment center. The primary hypotheses were: (1) the feasibility test (N=9) would yield improved percent days abstinent from all substances (excluding tobacco) from baseline to the 8-month follow-up, and (2) In the pilot randomized controlled trial of MICRA versus treatment as usual (TAU), the investigators hypothesized that percent days abstinent from all substances would be greater at the 12-month follow-up timepoint compared to TAU.

Conditions

Substance Use Disorders

Keywords

Addiction treatment outcome; American Indian/Alaska Native; Indigenous; randomized controlled trial; Motivational Interviewing; Community Reinforcement Approach; Substance Use Disorder; Cultural Adaptation

Outcome Measures

Primary Outcomes (1)

• Percent days abstinence from substances

  using the Form-90 for drugs (Form 90-D questionnaire), the investigators will examine percent days abstinent from all substances and conduct statistical tests to determine whether there is a significant difference between the treatment and comparison conditions

  baseline to 12-month follow-up

Secondary Outcomes (2)

• Condom Use Self Efficacy (questionnaire)

  baseline to 12 month follow-up

• Native American Spirituality Scale (questionnaire)

  baseline to 12 month follow-up

Study Arms (2)

Motivational Interviewing and Community Reinforcement Approach

ACTIVE COMPARATOR

A psychosocial intervention culturally tailoring the combination of motivational interviewing (approximately 1-3 individual therapy sessions) and the community reinforcement approach (could include maximum range of 15-19 individual therapy sessions). Two tribal members were hired and trained to deliver this intervention and were located separately from the other arm.

Behavioral: MICRA

Treatment as Usual

ACTIVE COMPARATOR

Treatment as usual (TAU) included an intake session and could include individual counseling, group counseling, or cultural education. Treatment as usual was provided by staff at the reservation based outpatient treatment center. There was no limit on number of sessions provided.

Behavioral: TAU

Interventions

MICRA BEHAVIORAL

see earlier description

Also known as: culturally adapted motivational interviewing and community reinforcement approach

Motivational Interviewing and Community Reinforcement Approach

TAU BEHAVIORAL

see earlier description

Also known as: Treatment As Usual

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• years or older,
• an enrolled tribal member,
• diagnosed with a Diagnostic and Statistical Manual (DSM-IV-TR) for substance use disorder (SUD),
• seeking substance use disorder treatment
• and able to speak English fluently
• resident within the reservation or neighboring small settlements

You may not qualify if:

• any planned absences from reservation greater than 14 days during the 16 week treatment period,
• cannot identify at least one "locator" person for follow-up tracking,
• actively psychotic or chronic mental illness that is not well treated, or
• major cognitive impairment.

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Drug Abuse (NIDA): collaborator

Related Publications (6)

• Greenfield BL, Venner KL. Review of substance use disorder treatment research in Indian country: future directions to strive toward health equity. Am J Drug Alcohol Abuse. 2012 Sep;38(5):483-92. doi: 10.3109/00952990.2012.702170.

  PMID: 22931083 BACKGROUND

• Venner KL, Serier K, Sarafin R, Greenfield BL, Hirchak K, Smith JE, Witkiewitz K. Culturally tailored evidence-based substance use disorder treatments are efficacious with an American Indian Southwest tribe: an open-label pilot-feasibility randomized controlled trial. Addiction. 2021 Apr;116(4):949-960. doi: 10.1111/add.15191. Epub 2020 Aug 11.

  PMID: 32667105 BACKGROUND

• Serier KN, Venner KL, Hernandez-Vallant A. The Condom Use Self-Efficacy Scale in Substance Use Disorder Treatment-Seeking American Indian Adults. Subst Use Misuse. 2021;56(13):2066-2073. doi: 10.1080/10826084.2021.1963988. Epub 2021 Sep 30.

  PMID: 34590538 BACKGROUND

• Greenfield BL, Hallgren KA, Venner KL, Hagler KJ, Simmons JD, Sheche JN, Homer E, Lupee D. Cultural adaptation, psychometric properties, and outcomes of the Native American Spirituality Scale. Psychol Serv. 2015 May;12(2):123-133. doi: 10.1037/ser0000019.

  PMID: 25961648 RESULT

• Venner KL, Greenfield BL, Hagler KJ, Simmons J, Lupee D, Homer E, Yamutewa Y, Smith JE. Pilot Outcome Results of Culturally Adapted Evidence-Based Substance Use Disorder Treatment with a Southwest Tribe. Addict Behav Rep. 2016 Jun 1;3:21-27. doi: 10.1016/j.abrep.2015.11.002.

  PMID: 26951788 RESULT

• Serier KN, Venner KL, Sarafin RE. Evaluating the Validity of the DSM-5 Alcohol Use Disorder Diagnostic Criteria in a Sample of Treatment-seeking Native Americans. J Addict Med. 2019 Jan/Feb;13(1):35-40. doi: 10.1097/ADM.0000000000000452.

  PMID: 30303888 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kamilla Venner, Ph.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two phases: Phase one: a feasibility (N = 9) non-randomized, one-group design wherein all participants received culturally adapted Motivational Interviewing and Community Reinforcement Approach (MICRA) Phase two: This study used a mixed efficacy/effectiveness (hybrid) randomized controlled trial of two treatment arms (Treatment as usual-TAU and Motivational Interviewing and Community Reinforcement Approach-MICRA) with a parallel design and follow-up assessments at 4-, 8-, and 12-months post baseline

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: July 10, 2023
• Study Start: August 1, 2007
• Primary Completion: November 18, 2013
• Study Completion: June 30, 2014
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share