NCT02290938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

June 26, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

July 10, 2014

Results QC Date

October 27, 2021

Last Update Submit

June 5, 2024

Conditions

Alcohol UseMarijuana Use

Keywords

adolescentsNative Americanalcohol usedrug useculturaltraditional activitiescultural identification

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Used Alcohol 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

    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 Outcomes (12)

  • Number of Participants Who Reported Consequences of Alcohol Use

    change from baseline to 6 months

  • Number of Participants Who Reported Consequences of Marijuana Use

    change from baseline to 6 months

  • Change in Intentions to Use - Alcohol

    change from baseline to 6 months

  • Change in Intentions to Use - Cigarettes

    change from baseline to 6 months

  • Change in Intentions to Use - Marijuana

    change from baseline to 6 months

  • +7 more secondary outcomes

Study Arms (2)

Community Wellness Gatherings

ACTIVE COMPARATOR

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

Community Wellness Gathering + MICUNAY

EXPERIMENTAL

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

Interventions

MICUNAYBEHAVIORAL

MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.

Community Wellness Gathering + MICUNAY
Community Wellness GatheringOTHER

a monthly gathering focused on making healthy choices and learning about Native American culture

Community Wellness Gatherings

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • identify as Native American
  • age 14-18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

United American Indian Involvement, Inc

Los Angeles, California, 90017, United States

Location

American Indian Child Resource Center

Oakland, California, 94610, United States

Location

Related Publications (8)

  • 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.

    PMID: 27130360BACKGROUND

  • 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.

    PMID: 14600049BACKGROUND

  • 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.

    PMID: 18037603BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27450682BACKGROUND

  • 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.

    PMID: 12008794BACKGROUND

  • 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.

    PMID: 33231130DERIVED

MeSH Terms

Conditions

Alcohol DrinkingMarijuana Use

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersMental Disorders

Results Point of Contact

Title
Elizabeth D'Amico
Organization
RAND
damico@rand.org
310-393-0411

Study Officials

  • Elizabeth D'Amico, PhD

    RAND

    PRINCIPAL INVESTIGATOR

  • Daniel Dickerson, D.O., M.P.H

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

November 14, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2017

Study Completion

June 1, 2018

Last Updated

June 26, 2024

Results First Posted

June 26, 2024

Record last verified: 2024-06

Locations

US(2)