A Randomized Controlled Trial of Culturally Adapted Evidence-based Treatment With a Southwest Tribe
NCT05938764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2024-03-12
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
Interventions
- BEHAVIORAL
-
MICRA
see earlier description
- BEHAVIORAL
-
TAU
see earlier description
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
University of New Mexico
lead OTHER
Principal Investigators
-
Kamilla Venner, Ph.D. · University of New Mexico
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-08-01
- Primary Completion
- 2013-11-18
- Completion
- 2014-06-30
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