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

Substance Use Disorders Clinical Trial

— MICRA  

Official title:

An Open-Label, Pilot-Feasibility Randomized Controlled Trial of Motivational Interviewing and the Community Reinforcement Approach With a Southwest Tribe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05938764
• Other study ID #: 06-235
• Secondary ID: R01DA021672
• Status: Completed
• Phase: N/A
• Start date: August 1, 2007
• Est. completion date: June 30, 2014

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 Human Immunodeficiency Virus / sexually transmitted disease (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: MICRA was conducted in two phases: Phase 1 was a feasibility (N = 9) non-randomized one-group design wherein all participants received culturally adapted MICRA. The purpose of Phase 1 was to (a) implement and test the draft version of the MICRA counselor manual, (b) test counselor fidelity monitoring procedures, (c) certify counselors in MI and CRA, (d) test the assessment procedures and basic aspects of the Manual of Operations, (e) certify the research assistant in assessment administration procedures, and (e) pilot the 4- and 8-month follow-ups.

Phase 2 was a mixed efficacy/effectiveness (hybrid) randomized controlled trial of MICRA (n=38) and TAU (n=41) with a parallel design and follow-up assessments at 4-, 8-, and 12-months post baseline. 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 of culturally adapted MICRA (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 culturally adapted 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 30, 2014
• Est. primary completion date: November 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• MICRA
see earlier description
• TAU
see earlier description

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Drug Abuse (NIDA)

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Condom Use Self Efficacy (questionnaire)	Condom Use Self-Efficacy Scale (questionnaire); the investigators will examine whether there are significant increases in condom use self-efficacy for the sample from baseline to 12-month follow-up	baseline to 12 month follow-up
Secondary	Native American Spirituality Scale (questionnaire)	The investigators will examine whether spiritual beliefs and behaviors increase over time from baseline to the 12-month follow-up for the sample using the total score as well as the two subscales (spiritual beliefs and spiritual behaviors)	baseline to 12 month follow-up