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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02290938
Other study ID # 1R01AA022066
Secondary ID 1R01AA022066
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date June 2018

Study information

Verified date April 2019
Source RAND
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date June 2018
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria:

- identify as Native American

- age 14-18

Exclusion Criteria:

- just need to meet inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States United American Indian Involvement, Inc Los Angeles California
United States American Indian Child Resource Center Oakland California

Sponsors (5)

Lead Sponsor Collaborator
RAND National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), Sacred Path Indigenous Wellness Center, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary alcohol use --this is a standard question used in Monitoring the Future (Miech, Johnston, O'Malley, Bachman, & Schulenberg, 2016). how many times used alcohol in the past 3 months change from baseline to 6 months
Primary marijuana use--this is a standard question used in Monitoring the Future (Miech, Johnston, O'Malley, Bachman, & Schulenberg, 2016). how many times used marijuana in the past 3 months change from baseline to 6 months
Secondary spirituality 12-item Functional Assessment of Chronic Illness Therapy-Fatigue-Spiritual Questions instrument, or FACIT-SP 12 change from baseline to 6 months
Secondary cultural identification Multi-Group Ethnic Identity Measure change from baseline to 6 months
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