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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05938764
Acronym
MICRA
Enrollment
87
Registered
2023-07-10
Start date
2007-08-01
Completion date
2014-06-30
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed 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.

Interventions

BEHAVIORALMICRA

see earlier description

BEHAVIORALTAU

see earlier description

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent days abstinence from substancesbaseline to 12-month follow-upusing 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

Secondary

MeasureTime frameDescription
Condom Use Self Efficacy (questionnaire)baseline to 12 month follow-upCondom 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
Native American Spirituality Scale (questionnaire)baseline to 12 month follow-upThe 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026