Clinical trial NCT04617938: TACUNA (Traditions and Connections for Urban Native Americans)
Official title: Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use
Alcohol Drinking
Marijuana Use
Keywords: American Indian/Alaska Native young adults
Cultural intervention
Motivational interviewing
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Sacred Path Indigenous Wellness Center
First posted: 2020-11-05
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study responds to Request For Application-DA-19-035, HEAL (Helping End Addiction Long Term) initiative: Preventing OUD in Older Adolescents and Young Adults (ages 16-30) by developing and implementing a culturally centered intervention to address opioid use among urban AI/AN emerging adults in California. The primary goal of this study is to compare AI/AN emerging adults who receive TACUNA plus a Wellness Circle (WC) to those AI/AN emerging adults who receive an opioid education workshop on outcomes (e.g., opioid misuse and alcohol and other drug use) over a period of 12 months. TACUNA will be a motivational interviewing group intervention that incorporates traditional practices and discussion of how to cultivate healthy social networks and cultural worlds. The Wellness gathering will be for emerging adults and people in their social network, and will focus on how social networks and cultural connectedness influence healthy behaviors. Opioid education will focus on discussion of opioid misuse within the AI/AN urban community and ways to reduce use in a culturally appropriate manner. Investigators expect those who receive TACUNA + WG will report less opioid and AOD (alcohol and other drug) use frequency, fewer consequences, less time spent around peers who use opioids and AOD, and less perceived prevalence of peer use compared to opioid education over a period of 12 months. Also, investigators will evaluate the intervention's effects on secondary outcomes of social networks and cultural connectedness. Survey data is collected at baseline, 3-months, 6-months and 12-months. Longitudinal analyses will compare intervention participant and control participants on primary and secondary outcomes.

Detailed description: Data from 2015 show that American Indians/Alaska Natives (AI/ANs) have the highest rates of diagnosis for opioid use disorders (OUD) and deaths from drug overdose. Misuse of prescription opioids, defined here as taking opioid medications in a manner or dose other than prescribed or for hedonic effects, and the use of heroin, have emerged as major public health concerns in the United States. Of particular concern is the prevalence of opioid use among emerging adults (ages 18-25) as this is a developmental period of heightened vulnerability and critical social, neurological, and psychological development.

Unique risk factors may predispose urban AI/AN young adults to use opioids, alcohol or other drugs. For example, experiences of acculturative stress directly and indirectly associated with historical trauma experienced by AI/ANs throughout U.S. history result in poor health outcomes. One U.S. law that has been postulated to contribute to various health disparities among urban AI/ANs is the Relocation Act of 1956. This Act financed the relocation of individual AIs and AI families to job training centers in designated U.S. cities. Rather than establishing economic stability, large numbers of AIs who moved to urban areas became unemployed, homeless, and disconnected from their community-based support networks. This relocation appears to have contributed to an inter-generational effect whereby successive generations of urban AIs and ANs continue to experience various health-related disparities. Our work with urban AI/AN adolescents highlighted that many experience stress related to identity in the form of both subtle (e.g., being asked whether one is a "real" Indian) and overt (e.g., being called a racist name like Squaw or Red Skin) discrimination. Programming that incorporates traditional practices, promotes community involvement, and encourages healthy notions of AI/AN identity may increase well-being and healthy behaviors by addressing sources of stress linked to cultural identity, stigma, and community connections. However, few evidence-based programs that integrate these cultural elements have been developed, implemented, and evaluated with urban AI/AN using a strong research design. The current study substantially extends work with AI/AN emerging adults by adapting and testing an integrated culturally appropriate MI and social network intervention to address opioid and other AOD (alcohol and other drug) misuse at both the individual and community level.

Eligibility criteria: Inclusion Criteria:

* must self-identify as American Indian/Alaska Native (AI/AN)
* be in the age range of 18-25
* not be in need of substance treatment

Exclusion Criteria:

* If substance treatment need is indicated

Primary outcomes:
measure: Frequency of opioid use
timeFrame: change from baseline to 3 months
measure: Frequency of opioid use
timeFrame: change from baseline to 6 months
measure: Frequency of opioid use
timeFrame: change from baseline to 12 months
measure: Frequency of alcohol and marijuana use
timeFrame: change from baseline to 3 months
measure: Frequency of alcohol and marijuana use
timeFrame: change from baseline to 6 months
measure: Frequency of alcohol and marijuana use
timeFrame: change from baseline to 12 months
Secondary outcomes:
measure: Network Composition
timeFrame: change from baseline to 3 months
measure: Network Composition
timeFrame: change from baseline to 6 months
measure: Network Composition
timeFrame: change from baseline to 12 months
measure: Cultural connectedness
timeFrame: change from baseline to 3 months
measure: Cultural connectedness
timeFrame: change from baseline to 6 months
measure: Cultural connectedness
timeFrame: change from baseline to 12 months
measure: Network Structure
timeFrame: change from baseline to 3 months
measure: Network Structure
timeFrame: change from baseline to 6 months
measure: Network Structure
timeFrame: change from baseline to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: United American Indian Involvement, Inc
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Santa Monica
country: United States
facility: RAND Corporation
state: California
Study officials:
affiliation: RAND
name: Elizabeth D'Amico, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLA Integrated Substance Abuse Programs
name: Daniel Dickerson, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kennedy DP, D'Amico EJ, Brown RA, Palimaru AI, Dickerson DL, Johnson CL, Lopez A. Feasibility and acceptability of incorporating social network visualizations into a culturally centered motivational network intervention to prevent substance use among urban Native American emerging adults: a qualitative study. Addict Sci Clin Pract. 2022 Sep 30;17(1):53. doi: 10.1186/s13722-022-00334-1.
citation: D'Amico EJ, Dickerson DL, Rodriguez A, Brown RA, Kennedy DP, Palimaru AI, Johnson C, Smart R, Klein DJ, Parker J, McDonald K, Woodward MJ, Gudgell N. Integrating traditional practices and social network visualization to prevent substance use: study protocol for a randomized controlled trial among urban Native American emerging adults. Addict Sci Clin Pract. 2021 Sep 26;16(1):56. doi: 10.1186/s13722-021-00265-3.