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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-01

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Motivational Interviewing and Community Reinforcement Approach

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.

Group Type ACTIVE_COMPARATOR

MICRA

Intervention Type BEHAVIORAL

see earlier description

Treatment as Usual

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.

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type BEHAVIORAL

see earlier description

Interventions

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MICRA

see earlier description

Intervention Type BEHAVIORAL

TAU

see earlier description

Intervention Type BEHAVIORAL

Other Intervention Names

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culturally adapted motivational interviewing and community reinforcement approach Treatment As Usual

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No