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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02290938

Acronym

MICUNAY

Enrollment

185

Registered

2014-11-14

Start date

2014-07-31

Completion date

2018-06-30

Last updated

2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use, Marijuana Use

Keywords

adolescents, Native American, alcohol use, drug use, cultural, traditional activities, cultural identification

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.

Interventions

BEHAVIORALMICUNAY

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

OTHERCommunity Wellness Gathering

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* identify as Native American * age 14-18

Exclusion criteria

* just need to meet inclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Used Alcohol From Baseline to 6 Months	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.
Number of Participants Who Used Marijuana From Baseline to 6 Months	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.

Secondary

Measure	Time frame	Description
Change in Intentions to Use - Alcohol	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 in Intentions to Use - Cigarettes	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 in Intentions to Use - Marijuana	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 in Alcohol Resistance Self-efficacy	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 in Peer Influence - Alcohol	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).
Number of Participants Who Reported Consequences of Alcohol Use	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 in Peer Influence - Cigarettes	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 in Intentions to Participate in Traditional Practices	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 in Cultural Identification	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 in Spirituality/Happiness	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 in Peer Influence - Marijuana	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).
Number of Participants Who Reported Consequences of Marijuana Use	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.

Countries

United States

Participant flow

Pre-assignment details

Given the importance to our partnering Native communities that every teen receive some culturally relevant intervention, our control group was not the standard control that is often seen in RCTs. Our control group comprised a large cultural event (Community Wellness Gathering or CWG) designed to connect adolescents with their heritage and AI/AN resources in their community. The intervention group received the CWG + MICUNAY.

Participants by arm

Arm	Count
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 Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	70
Community Wellness Gathering + MICUNAY Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.	115
Total	185

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	14	43

Baseline characteristics

Characteristic	Total	Community Wellness Gathering + MICUNAY	Community Wellness Gatherings
Age, Continuous	15.61 years STANDARD_DEVIATION 1.33	15.66 years STANDARD_DEVIATION 1.41	15.51 years STANDARD_DEVIATION 1.18
Ethnicity (NIH/OMB) Hispanic or Latino	83 Participants	55 Participants	28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 Participants	60 Participants	42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Minimum of Graduated from High School (father)	94 Participants	55 Participants	39 Participants
Minimum of Graduated from High School (mother)	120 Participants	71 Participants	49 Participants
Race (NIH/OMB) American Indian or Alaska Native	109 Participants	70 Participants	39 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	6 Participants	4 Participants	2 Participants
Race (NIH/OMB) More than one race	43 Participants	22 Participants	21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants	1 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants	15 Participants	6 Participants
Race (NIH/OMB) White	4 Participants	3 Participants	1 Participants
Sex: Female, Male Female	95 Participants	47 Participants	48 Participants
Sex: Female, Male Male	90 Participants	68 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 70	0 / 115
other Total, other adverse events	0 / 70	0 / 115
serious Total, serious adverse events	0 / 70	0 / 115

Outcome results

Primary

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.