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

Primary Purpose

Opioid Use, Alcohol Drinking, Marijuana Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TACUNA plus Wellness Circle
Opioid Education Workshop
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Use focused on measuring American Indian/Alaska Native young adults, Cultural intervention, Motivational interviewing

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • United American Indian Involvement, IncRecruiting
  • UCLARecruiting
  • RAND CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TACUNA

Opioid education

Arm Description

Randomized participants will attend 3 virtual 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 Circle, focused on healthy social networks and engaging in traditional practices.

Randomized participants will attend 1 virtual 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.

Outcomes

Primary Outcome Measures

Frequency of opioid use
We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
Frequency of opioid use
We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
Frequency of opioid use
We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
Frequency of alcohol and marijuana use
We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.
Frequency of alcohol and marijuana use
We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.
Frequency of alcohol and marijuana use
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

Network Composition
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).
Network Composition
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).
Network Composition
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).
Cultural connectedness
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).
Cultural connectedness
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).
Cultural connectedness
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).
Network Structure
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.
Network Structure
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.
Network Structure
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.

Full Information

First Posted
October 26, 2020
Last Updated
June 28, 2023
Sponsor
RAND
Collaborators
University of California, Los Angeles, Sacred Path Indigenous Wellness Center
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1. Study Identification

Unique Protocol Identification Number
NCT04617938
Brief Title
TACUNA (Traditions and Connections for Urban Native Americans)
Acronym
TACUNA
Official Title
Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
University of California, Los Angeles, Sacred Path Indigenous Wellness Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Alcohol Drinking, Marijuana Use
Keywords
American Indian/Alaska Native young adults, Cultural intervention, Motivational interviewing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TACUNA
Arm Type
Experimental
Arm Description
Randomized participants will attend 3 virtual 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 Circle, focused on healthy social networks and engaging in traditional practices.
Arm Title
Opioid education
Arm Type
Active Comparator
Arm Description
Randomized participants will attend 1 virtual 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.
Intervention Type
Behavioral
Intervention Name(s)
TACUNA plus Wellness Circle
Intervention Description
TACUNA provides three virtual workshops (one hour each) that use motivational interviewing and a virtual Wellness Circle (WC). The workshops combine a 30-minute discussion of opioid, alcohol and marijuana use, and social networks with another 30 minutes focused on three different traditional practices (one per workshop). 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 Circle, youth will have members of their social network virtually attend these once-a-month gatherings. The WC will bring people together to celebrate health and wellness and tradition. The WC 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.
Intervention Type
Behavioral
Intervention Name(s)
Opioid Education Workshop
Intervention Description
The virtual 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.
Primary Outcome Measure Information:
Title
Frequency of opioid use
Description
We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
Time Frame
change from baseline to 3 months
Title
Frequency of opioid use
Description
We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
Time Frame
change from baseline to 6 months
Title
Frequency of opioid use
Description
We will assess frequency of opioid use in the past three months from 1 = never to 6 = over 20 times.
Time Frame
change from baseline to 12 months
Title
Frequency of alcohol and marijuana use
Description
We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.
Time Frame
change from baseline to 3 months
Title
Frequency of alcohol and marijuana use
Description
We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.
Time Frame
change from baseline to 6 months
Title
Frequency of alcohol and marijuana use
Description
We will assess frequency of alcohol and marijuana use in the past three months from 1 = never to 6 = over 20 times.
Time Frame
change from baseline to 12 months
Secondary Outcome Measure Information:
Title
Network Composition
Description
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).
Time Frame
change from baseline to 3 months
Title
Network Composition
Description
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).
Time Frame
change from baseline to 6 months
Title
Network Composition
Description
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).
Time Frame
change from baseline to 12 months
Title
Cultural connectedness
Description
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).
Time Frame
change from baseline to 3 months
Title
Cultural connectedness
Description
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).
Time Frame
change from baseline to 6 months
Title
Cultural connectedness
Description
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).
Time Frame
change from baseline to 12 months
Title
Network Structure
Description
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.
Time Frame
change from baseline to 3 months
Title
Network Structure
Description
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.
Time Frame
change from baseline to 6 months
Title
Network Structure
Description
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.
Time Frame
change from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth J. D'Amico, PhD
Phone
310-393-0411
Ext
6487
Email
damico@rand.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Woodward
Phone
310-393-0411
Ext
6595
Email
michaelw@rand.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth D'Amico, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Dickerson, DO, MPH
Organizational Affiliation
UCLA Integrated Substance Abuse Programs
Official's Role
Principal Investigator
Facility Information:
Facility Name
United American Indian Involvement, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Johnson, PhD
Phone
213-241-0979
Ext
7136
Email
DrCJohnsn@aol.com
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Woodward
Phone
310-393-0411
Ext
6595
Email
michaelw@rand.org
First Name & Middle Initial & Last Name & Degree
Daniel Dickerson, DO, MPH
Facility Name
RAND Corporation
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Woodward
Phone
310-393-0411
Ext
6595
Email
michaelw@rand.org
First Name & Middle Initial & Last Name & Degree
Elizabeth J D'Amico, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36180896
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.
Results Reference
derived
PubMed Identifier
34565444
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.
Results Reference
derived

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TACUNA (Traditions and Connections for Urban Native Americans)

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