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

Sponsor

University of New Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT05938764

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders	Behavioral: MICRA Behavioral: TAU	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 baselineTwo 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Nov 18, 2013

Actual Study Completion Date :

Jun 30, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: MICRA see earlier description Other Names: culturally adapted motivational interviewing and community reinforcement approach
Active Comparator: 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.	Behavioral: TAU see earlier description Other Names: Treatment As Usual

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: MICRA

see earlier description

Other Names:

culturally adapted motivational interviewing and community reinforcement approach

Active Comparator: 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.

Behavioral: TAU

see earlier description

Other Names:

Treatment As Usual

Outcome Measures

Primary Outcome Measures

Percent days abstinence from substances [baseline to 12-month follow-up]
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

Secondary Outcome Measures

Condom Use Self Efficacy (questionnaire) [baseline to 12 month follow-up]
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
Native American Spirituality Scale (questionnaire) [baseline to 12 month follow-up]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.