TACUNA (Traditions and Connections for Urban Native Americans) (TACUNA)

• ClinicalTrials.gov Identifier: NCT04617938
• Recruitment Status: Recruiting
• First Posted: November 5, 2020
• Last Update Posted: November 9, 2020
• Sponsor: RAND
• Collaborators: University of California, Los Angeles; Sacred Path Indigenous Wellness Center
• Information provided by (Responsible Party): RAND

Study Description

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 Gathering (WG) 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.

Condition or disease	Intervention/treatment	Phase
Opioid Use; Alcohol Drinking; Marijuana Use	Behavioral: TACUNA plus Wellness Gathering; Behavioral: Opioid Education Workshop	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 375 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California
• Actual Study Start Date: October 25, 2020
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: April 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: TACUNA; Randomized participants will attend 3 TACUNA workshops, focused on behavioral, physical, and spiritual domains, and designed to guide AI/AN youth to make healthy choices surrounding opioid and AOD use. They will also attend a wellness gathering, focused on healthy social networks and engaging in traditional practices.	Behavioral: TACUNA plus Wellness Gathering; TACUNA provides three virtual workshops (two hours each) that use motivational interviewing and a virtual wellness gathering (WG). The workshops combine a one hour discussion of opioid, alcohol and marijuana use and social networks with one hour focused on three different traditional practices. TACUNA was adapted from our three-session workshop, MICUNAY (Motivational Interviewing and Culture for Urban Native American Youth) protocol, which was developed and tested for urban AI/AN adolescents and from focus groups conducted in Year 1. For the Wellness Gathering, youth will have members of their social network virtually attend these once-a-month gatherings. The WG will bring people together to celebrate health and wellness and tradition. The WG will focus on the importance of social networks in making healthy choices, and provide discussion on the role that AOD use and engagement in traditional practices among members of their social networks affect their choices.
Active Comparator: Opioid education; Randomized participants will attend 1 opioid education workshop, focused on behavioral and physical domains, and designed to guide AI/AN youth to make healthy choices surrounding opioid and AOD use.	Behavioral: Opioid Education Workshop; The opioid education workshop draws from prevention and education materials supplied and recommended by the National AI/AN Technology and Transfer Center, which is funded by SAMHSA. Materials are culturally relevant educational packages addressing opioid use through recorded webinars, toolkits, and other resources.

Outcome Measures

Primary Outcome Measures :

1. Frequency of opioid use [ Time Frame: change from baseline to 3 months ]
   We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
2. Frequency of opioid use [ Time Frame: change from baseline to 6 months ]
   We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
3. Frequency of opioid use [ Time Frame: change from baseline to 12 months ]
   We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
4. Frequency of alcohol and marijuana use [ Time Frame: change from baseline to 3 months ]
   We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.
5. Frequency of alcohol and marijuana use [ Time Frame: change from baseline to 6 months ]
   We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.
6. Frequency of alcohol and marijuana use [ Time Frame: change from baseline to 12 months ]
   We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.

Secondary Outcome Measures :

1. Network Composition [ Time Frame: change from baseline to 3 months ]
   Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participants the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/Ans, % who engage in heavy drinking).
2. Network Composition [ Time Frame: change from baseline to 6 months ]
   Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participants the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/Ans, % who engage in heavy drinking).
3. Network Composition [ Time Frame: change from baseline to 12 months ]
   Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participants the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/Ans, % who engage in heavy drinking).
4. Cultural connectedness [ Time Frame: change from baseline to 3 months ]
   Cultural connectedness will be measured with 29 items that address 3 dimensions: identity, traditions, and spirituality. Respondents answer 11 yes/no questions (e.g., I have a traditional person, Elder, or other person who I talk to), and use a scale from 1= "strongly disagree" to 5= "strongly agree" for 18 items (e.g., I feel a strong connection/attachment towards my Native American community or Tribe).
5. Cultural connectedness [ Time Frame: change from baseline to 6 months ]
   Cultural connectedness will be measured with 29 items that address 3 dimensions: identity, traditions, and spirituality. Respondents answer 11 yes/no questions (e.g., I have a traditional person, Elder, or other person who I talk to), and use a scale from 1= "strongly disagree" to 5= "strongly agree" for 18 items (e.g., I feel a strong connection/attachment towards my Native American community or Tribe).
6. Cultural connectedness [ Time Frame: change from baseline to 12 months ]
   Cultural connectedness will be measured with 29 items that address 3 dimensions: identity, traditions, and spirituality. Respondents answer 11 yes/no questions (e.g., I have a traditional person, Elder, or other person who I talk to), and use a scale from 1= "strongly disagree" to 5= "strongly agree" for 18 items (e.g., I feel a strong connection/attachment towards my Native American community or Tribe).
7. Network Structure [ Time Frame: change from baseline to 3 months ]
   Participants will rate the relationship strength between each of the 15 named alters. For each alter pair they will rate if the two people know each other and, if yes, have they connected recently. Measures of network structure (i.e. network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.
8. Network Structure [ Time Frame: change from baseline to 6 months ]
   Participants will rate the relationship strength between each of the 15 named alters. For each alter pair they will rate if the two people know each other and, if yes, have they connected recently. Measures of network structure (i.e. network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.
9. Network Structure [ Time Frame: change from baseline to 12 months ]
   Participants will rate the relationship strength between each of the 15 named alters. For each alter pair they will rate if the two people know each other and, if yes, have they connected recently. Measures of network structure (i.e. network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Elizabeth J. D'Amico, PhD; 310-393-0411 ext 6487; damico@rand.org

Contact: Michael Woodward; 310-393-0411 ext 6595; michaelw@rand.org

Locations

United States, California

United American Indian Involvement, Inc; Recruiting

Los Angeles, California, United States, 90017

Contact: Carrie Johnson, PhD 213-241-0979 ext 7136 DrCJohnsn@aol.com

UCLA; Recruiting

Los Angeles, California, United States, 90095

Contact: Michael Woodward 310-393-0411 ext 6595 michaelw@rand.org

Principal Investigator: Daniel Dickerson, DO, MPH

RAND Corporation; Recruiting

Santa Monica, California, United States, 90401

Contact: Michael Woodward 310-393-0411 ext 6595 michaelw@rand.org

Principal Investigator: Elizabeth J D'Amico, PhD

Sponsors and Collaborators

RAND

University of California, Los Angeles

Sacred Path Indigenous Wellness Center

Investigators

• Principal Investigator: Elizabeth D'Amico, PhD; RAND
• Principal Investigator: Daniel Dickerson, DO, MPH; UCLA Integrated Substance Abuse Programs

More Information

• Responsible Party: RAND
• ClinicalTrials.gov Identifier: NCT04617938
• Other Study ID Numbers: 4UH3DA050235 ( U.S. NIH Grant/Contract )
• First Posted: November 5, 2020
• Last Update Posted: November 9, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RAND:

American Indian/Alaska Native young adults; Cultural intervention; Motivational interviewing

Additional relevant MeSH terms:

Alcohol Drinking; Marijuana Use; Substance-Related Disorders; Mental Disorders; Drinking Behavior; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents