- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02290938
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
185
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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
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
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
Collaborators
Investigators
- 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
- D'Amico EJ, Miles JN, Stern SA, Meredith LS. Brief motivational interviewing for teens at risk of substance use consequences: a randomized pilot study in a primary care clinic. J Subst Abuse Treat. 2008 Jul;35(1):53-61. doi: 10.1016/j.jsat.2007.08.008. Epub 2007 Nov 26.
- Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med. 2002 Winter;24(1):49-58. doi: 10.1207/S15324796ABM2401_06.
- Dickerson DL, Parker J, Johnson CL, Brown RA, D'Amico EJ. Recruitment and retention in randomized controlled trials with urban American Indian/Alaska Native adolescents: Challenges and lessons learned. Clin Trials. 2021 Feb;18(1):83-91. doi: 10.1177/1740774520971774. Epub 2020 Nov 24.
- Phinney, J. S., & Ong, A. D. (2007). Conceptualization and measurement of ethnic identity: Current status and future directions. Journal of Counseling Psychology, 54(3), 271.
- D'Amico EJ, Tucker JS, Miles JN, Ewing BA, Shih RA, Pedersen ER. Alcohol and marijuana use trajectories in a diverse longitudinal sample of adolescents: examining use patterns from age 11 to 17 years. Addiction. 2016 Oct;111(10):1825-35. doi: 10.1111/add.13442. Epub 2016 Jun 14.
- Ellickson PL, McCaffrey DF, Ghosh-Dastidar B, Longshore DL. New inroads in preventing adolescent drug use: results from a large-scale trial of project ALERT in middle schools. Am J Public Health. 2003 Nov;93(11):1830-6. doi: 10.2105/ajph.93.11.1830.
- Ponterotto, J. G., Gretchen, D., Utsey, S. O., Stracuzzi, T., & Saya Jr, R. (2003). The multigroup ethnic identity measure (MEIM): Psychometric review and further validity testing. Educational and Psychological Measurement, 63(3), 502-515.
- Brown RA, Dickerson DL, D'Amico EJ. Cultural Identity Among Urban American Indian/Alaska Native Youth: Implications for Alcohol and Drug Use. Prev Sci. 2016 Oct;17(7):852-61. doi: 10.1007/s11121-016-0680-1.
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
July 1, 2014
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
July 10, 2014
First Submitted That Met QC Criteria
November 11, 2014
First Posted (Estimated)
November 14, 2014
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01AA022066 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Marijuana Use
-
Michael SofisDartmouth CollegeRecruitingTobacco Use | Marijuana Use | Alcohol Use, Unspecified | Marijuana DependenceUnited States
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)RecruitingMarijuana Abuse | Marijuana Use | Addiction | Substance Use | Cannabis Dependence | Substance Use Disorders | Cannabis Use | Substance Abuse | Addiction, Substance | Marijuana Dependence | Substance Dependence | Marijuana Smoking | Cannabis Abuse | Cannabis Use Disorder | Marijuana | Cannabis Intoxication | Substance Related... and other conditionsUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedMarijuana Use DisorderUnited States
-
Shanna Babalonis, PhDNational Institute on Drug Abuse (NIDA)Completed
-
Brown UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)RecruitingTobacco Smoking | Behavioral Economics | Cannabis SmokingUnited States
-
Western University, CanadaRecruitingCannabis Use | Marijuana Smoking | Cannabis Smoking | Marijuana UsageCanada
-
Brown UniversityCompleted
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene...CompletedMarijuana SmokingUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)Completed
-
State University of New York at BuffaloCompleted
Clinical Trials on Community Wellness Gathering
-
Utica CollegeCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingHospitalization in a Post-Resuscitation Rehabilitation Care UnitsFrance
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
VA Office of Research and DevelopmentCompletedSchizophrenia | Serious Mental IllnessUnited States
-
Oregon Health and Science UniversityProvidence Health & Services; Legacy Health SystemEnrolling by invitation
-
The University of Hong KongThe Hong Kong Council of Social ServiceCompleted
-
University of ConnecticutDepartment of Health and Human Services; Meals on Wheels Rhode Island (MOWRI)Enrolling by invitationQuality of Life | Food Insecurity | Loneliness | Diet, HealthyUnited States
-
Hospital Sao RafaelCompleted
-
The University of Hong KongThe Hong Kong Jockey Club Charities Trust; Hong Kong Young Women's Christian... and other collaboratorsRecruiting
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenCompletedType1 Diabetes MellitusBelgium