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

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ClinicalTrials.gov Identifier: NCT02290938
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
University of California, Los Angeles
Sacred Path Indigenous Wellness Center
Information provided by (Responsible Party):
RAND

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date April 26, 2019
Study Start Date  ICMJE July 2014
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • alcohol use --this is a standard question used in Monitoring the Future (Miech, Johnston, O'Malley, Bachman, & Schulenberg, 2016). [ Time Frame: change from baseline to 6 months ]
    how many times used alcohol in the past 3 months
  • marijuana use--this is a standard question used in Monitoring the Future (Miech, Johnston, O'Malley, Bachman, & Schulenberg, 2016). [ Time Frame: change from baseline to 6 months ]
    how many times used marijuana in the past 3 months
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • alcohol use [ Time Frame: change from baseline to 3 months ]
    in the past 30 days: Number of times used alcohol, number of drinks, number of heavy drinking days
  • marijuana use [ Time Frame: change from baseline to 3 months ]
    in the past 30 days: Number of times used marijuana
  • alcohol use [ Time Frame: change from baseline to 6 months ]
    in the past 30 days: Number of times used alcohol, number of drinks, number of heavy drinking days
  • marijuana use [ Time Frame: change from baseline to 6 months ]
    in the past 30 days: Number of times used marijuana
  • spirituality [ Time Frame: change from baseline to 6 months ]
    instrument that assesses spirituality involvement and beliefs over the past 7 days (e.g., I feel peaceful; I feel connected to a higher power).
  • Cultural identification [ Time Frame: change from baseline to 6 months ]
    Multi-Group Ethnic Identity Measure
Change History Complete list of historical versions of study NCT02290938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • spirituality [ Time Frame: change from baseline to 6 months ]
    12-item Functional Assessment of Chronic Illness Therapy-Fatigue-Spiritual Questions instrument, or FACIT-SP 12
  • cultural identification [ Time Frame: change from baseline to 6 months ]
    Multi-Group Ethnic Identity Measure
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • spirituality [ Time Frame: change from baseline to 3 months ]
    instrument that assesses spirituality involvement and beliefs over the past 7 days (e.g., I feel peaceful; I feel connected to a higher power).
  • cultural identification [ Time Frame: change from baseline to 3 months ]
    Multi-Group Ethnic Identity Measure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY)
Official Title  ICMJE Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY)
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Alcohol Use
  • Marijuana Use
Intervention  ICMJE
  • 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.
  • Other: Community Wellness Gathering
    a monthly gathering focused on making healthy choices and learning about Native American culture
Study Arms  ICMJE
  • 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
    Intervention: Other: Community Wellness Gathering
  • Experimental: MICUNAY
    MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
    Intervention: Behavioral: MICUNAY
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
185
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
200
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • identify as Native American
  • age 14-18

Exclusion Criteria:

  • just need to meet inclusion criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290938
Other Study ID Numbers  ICMJE 1R01AA022066( U.S. NIH Grant/Contract )
1R01AA022066 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RAND
Study Sponsor  ICMJE RAND
Collaborators  ICMJE
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute on Drug Abuse (NIDA)
  • University of California, Los Angeles
  • Sacred Path Indigenous Wellness Center
Investigators  ICMJE
Principal Investigator: Elizabeth D'Amico, PhD RAND
Principal Investigator: Daniel Dickerson, D.O., M.P.H University of California, Los Angeles
PRS Account RAND
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP