Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY) (MICUNAY)

June 5, 2024 updated by: RAND
The investigators plan to develop and test a new alcohol and other drug (AOD) intervention for urban AI/AN youth, "Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY)." This intervention integrates tradition-based activities and motivational interviewing (MI). The investigators will intervene at both the community and individual level. At the individual level, they will provide MICUNAY to adolescents. At the community level, they will provide discussion of AOD prevention at Community Wellness Gatherings (CWG). This work is important because they will gain an understanding of how well a tradition-based healing program that integrates MI works to prevent AOD use among urban AI/AN youth.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

American Indian/Alaska Native (AI/AN) youth report higher rates of alcohol and drug (AOD) use, greater frequency and intensity of AOD use, earlier first AOD use, and much higher alcohol-related mortality than other racial/ethnic groups in the U.S. Data regarding urban AIs/ANs are limited; however, one study found that at-risk AIs/AN adults in an urban setting report an earlier onset of alcohol, marijuana, methamphetamine, and other drug use compared to all other ethnic/racial groups within LA County. This proposal responds to PAR-11-346, Interventions for Health Promotion and Disease Prevention in Native American Populations, which is focused on developing, adapting, and testing the effectiveness of health promotion prevention interventions in Native American populations. The two co-PI's provide a unique blend of expertise that has resulted in the development of an innovative preliminary protocol for AI/AN youth: Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY), which integrates traditional healing approaches with motivational interviewing (MI). Dickerson is an Alaska Native (Inupiaq) new investigator who worked with the AI/AN community to obtain community-based perspectives on decreasing AOD use and mental health problems. D'Amico is internationally recognized for her work focused on the development and testing of MI interventions targeting AOD use for culturally diverse adolescents across different settings. Dickerson and colleagues have demonstrated the need for culturally-appropriate interventions for AI/AN youth. His two community-based projects found that there is a lack of programs integrating tradition-based healing with evidenced based treatments (EBTs), and this was cited as a significant barrier to seeking care within urban AI/AN populations. Therefore, MICUNAY will integrate tradition-based healing with MI. It consists of 6 weekly 1-hour sessions (3 MI AOD sessions and 3 tradition activity sessions). This proposal also incorporates a multi-system intervention approach. At the individual level, the investigators will provide MICUNAY to urban AI/AN youth. At the community level, they will discuss AOD use and AOD prevention among AI/AN youth at existing Community Wellness Gatherings (CWG). The proposed 5-year study will consist of two main components: 1) A Developmental Phase in which they conduct focus groups across two clinical sites in Los Angeles and Oakland with the community to establish feasibility and sustainability of delivery, 2) A randomized controlled trial comparing youth who only attend a CWG (n=100) to youth who attend a CWG plus receive MICUNAY (n=100). The investigators will compare outcomes at 3- and 6-month follow-up to determine (a) whether clinically significant changes in AOD expectancies, perceived prevalence of peer AOD use, alcohol consumption, marijuana and other drug use, and related consequences occur; (b) whether clinically significant changes in physical, social, emotional, and functional well-being as well as spirituality and cultural identification occur, and (c) if reductions occur, estimate effect sizes for the CWG group and the CWG plus MICUNAY group. This study substantially extends work with AI/AN youth by intervening at both the community and individual level, and developing and testing an integrated tradition-based AOD MI group intervention for urban AI/AN youth.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90017
        • United American Indian Involvement, Inc
      • Oakland, California, United States, 94610
        • American Indian Child Resource Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • identify as Native American
  • age 14-18

Exclusion Criteria:

  • just need to meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Community Wellness Gatherings
All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture
Other: Community Wellness Gathering
a monthly gathering focused on making healthy choices and learning about Native American culture
Experimental: Community Wellness Gathering + MICUNAY
MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Behavioral: MICUNAY
MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Used Alcohol From Baseline to 6 Months
Time Frame: change from baseline to 6 months
For this study, we created a dichotomous indicator of whether adolescents reported any use of alcohol. This is because alcohol use rates are typically lower in younger adolescents, leading to highly skewed distributions in continuous variables.
change from baseline to 6 months
Number of Participants Who Used Marijuana From Baseline to 6 Months
Time Frame: change from baseline to 6 months
For this study, we created a dichotomous indicator of whether adolescents reported any use of marijuana. This is because marijuana use rates are typically lower in younger adolescents, leading to highly skewed distributions in continuous variables.
change from baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Reported Consequences of Alcohol Use
Time Frame: change from baseline to 6 months
Adolescents reported on the alcohol consequences they had experienced in past three months. Consequences are based on DSM-IV criteria with 7 items for alcohol (e.g., missed school or work). For this analysis we created dichotomous indicators of whether adolescents reported any consequences from alcohol.
change from baseline to 6 months
Number of Participants Who Reported Consequences of Marijuana Use
Time Frame: change from baseline to 6 months
Adolescents reported on the marijuana consequences they had experienced in past three months. Consequences are based on DSM-IV criteria with 5 items for marijuana (e.g., had difficulty concentrating). For this analysis we created dichotomous indicators of whether adolescents reported any consequences from marijuana.
change from baseline to 6 months
Change in Intentions to Use - Alcohol
Time Frame: change from baseline to 6 months
Three separate items assessed whether adolescents believed they would drink any alcohol, use any marijuana, or smoke a cigarette in the next six months (1="definitely yes" to 4="definitely no").
change from baseline to 6 months
Change in Intentions to Use - Cigarettes
Time Frame: change from baseline to 6 months
Three separate items assessed whether adolescents believed they would drink any alcohol, use any marijuana, or smoke a cigarette in the next six months (1="definitely yes" to 4="definitely no").
change from baseline to 6 months
Change in Intentions to Use - Marijuana
Time Frame: change from baseline to 6 months
Three separate items assessed whether adolescents believed they would drink any alcohol, use any marijuana, or smoke a cigarette in the next six months (1="definitely yes" to 4="definitely no").
change from baseline to 6 months
Change in Alcohol Resistance Self-efficacy
Time Frame: change from baseline to 6 months
Alcohol resistance self-efficacy (RSE) for alcohol was defined as the average of four items rated from "I would definitely use" to "I would definitely not use" based on different situations (e.g., if my best friend were using; you were bored at party; your friend gives you a drink). RSE ranged from 1 to 4; higher scores indicated greater RSE.
change from baseline to 6 months
Change in Peer Influence - Alcohol
Time Frame: change from baseline to 6 months
Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often").
change from baseline to 6 months
Change in Peer Influence - Marijuana
Time Frame: change from baseline to 6 months
Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often").
change from baseline to 6 months
Change in Peer Influence - Cigarettes
Time Frame: change from baseline to 6 months
Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often").
change from baseline to 6 months
Change in Intentions to Participate in Traditional Practices
Time Frame: change from baseline to 6 months
Adolescents reported how likely they were to participate in >20 different traditional practices (e.g., going to Pow Wows, prayer, playing Native hand or stick games) in the next six months (1="definitely yes" to 4="definitely no").
change from baseline to 6 months
Change in Cultural Identification
Time Frame: change from baseline to 6 months
We assessed adolescents' AI/AN cultural pride and sense of belonging with the Multigroup Ethnic Identity Measure (MEIM), which has twelve items. Respondents are asked the degree to which they agree with statements such as, "I have a clear sense of my ethnic background and what it means to me" on a scale from 1 = "strongly disagree" to 5 = "strongly agree". Given that our prior focus group work indicated that many adolescents were of mixed ethnicity, and our focus was on AI/AN identity, we modified these items to focus on AI/AN heritage (e.g., "I have clear sense of my AI/AN identity and what it means to me").
change from baseline to 6 months
Change in Spirituality/Happiness
Time Frame: change from baseline to 6 months
Spirituality and happiness were measured using a subset of ten items from the 12-item Functional Assessment of Chronic Illness Therapy-Fatigue-Spiritual Questions instrument, or FACIT-SP 12. Adolescents reported agreement with statements such as "I find comfort in my faith or spiritual beliefs" and "I feel a sense of harmony within myself." Two items that referred specifically to chronic illness were removed from the scale as they were not relevant for this study. Response options, which ranged from 1="not at all" to 5="very much," were averaged, with negative statements reversed such that higher scores indicated greater spirituality and happiness.
change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RAND

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, Los Angeles
Sacred Path Indigenous Wellness Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Dickerson, D.O., M.P.H, University of California, Los Angeles
  • Principal Investigator: Elizabeth D'Amico, PhD, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01AA022066 (U.S. NIH Grant/Contract)

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