Substance Use DisordersMICRANCT05938764
A Randomized Controlled Trial of Culturally Adapted Evidence-based Treatment With a Southwest Tribe
A study testing MICRA and TAU in people with Substance Use Disorders, run by University of New Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- MICRA and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 30 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: An Open-Label, Pilot-Feasibility Randomized Controlled Trial of Motivational Interviewing and the Community Reinforcement Approach With a Southwest Tribe
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.
Read more
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- MICRA, TAU
- Keywords
- Addiction treatment outcome, American Indian/Alaska Native, Indigenous, randomized controlled trial, Motivational Interviewing, Community Reinforcement Approach, Substance Use Disorder, Cultural Adaptation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICRABehavioural
Also called culturally adapted motivational interviewing and community reinforcement approach
see earlier description
TAUBehavioural
Also called Treatment As Usual
see earlier description
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing and Community Reinforcement Approach | Active comparator | 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. Receives: Behavioral: MICRA |
| Treatment as Usual | Active comparator | 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. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 12-month follow-up
Secondary outcomes (2)
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
Measured: baseline to 12 month follow-up
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)
Measured: baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Aug 2007
- Primary completion18 Nov 2013
- Study completion30 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kamilla Venner, Ph.D., Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938764
- Sponsor's protocol ID
- 06-235
- Other IDs
- R01DA021672
- Acronym
- MICRA
- Status last verified
- Mar 2024
- First submitted
- 21 May 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: These data are owned by the tribe. If anyone would like to use these data, the PI will serve as the liaison to request permission from the tribe.
Publications
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.
PubMed 22931083Venner 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.
PubMed 32667105Serier 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.
PubMed 34590538Greenfield 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.
PubMed 25961648Venner 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/j.abrep.2015.11.002.
PubMed 26951788Serier 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.
PubMed 30303888
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot-Feasibility Randomized Controlled Trial of Motivational Interviewing and the Community Reinforcement Approach With a Southwest Tribe
- ClinicalTrials.gov ID
- NCT05938764
- Acronym / sponsor ID
- MICRA / 06-235
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 18 Nov 2013 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing and Community Reinforcement Approach | Active comparator | Behavioral: MICRAA 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. |
| Treatment as Usual | Active comparator | Behavioral: TAUTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICRAAlso: culturally adapted motivational interviewing and community reinforcement approachsee earlier description | Behavioural | Motivational Interviewing and Community Reinforcement Approach |
| TAUAlso: Treatment As Usualsee earlier description | Behavioural | Treatment as Usual |
Primary outcome
Percent days abstinence from substances
Time frame: 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
2 secondary outcomes
Condom Use Self Efficacy (questionnaire)
Time frame: baseline to 12 month follow-up
Native American Spirituality Scale (questionnaire)
Time frame: baseline to 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 22931083Greenfield 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.
- Background: PubMed 32667105Venner 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.
- Background: PubMed 34590538Serier 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.
- Results publication: PubMed 25961648Greenfield 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.
- Results publication: PubMed 26951788Venner 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/j.abrep.2015.11.002.
- Results publication: PubMed 30303888Serier 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.
- Individual participant dataSharing planned: No. These data are owned by the tribe. If anyone would like to use these data, the PI will serve as the liaison to request permission from the tribe.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamilla Venner, Ph.D. principal investigator
University of New Mexico
Questions about this trial
What is this clinical trial studying?
A study testing MICRA and TAU in people with Substance Use Disorders, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent days abstinence from substances (time frame: baseline to 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05938764, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.