- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04617938
TACUNA (Traditions and Connections for Urban Native Americans) (TACUNA)
Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth J. D'Amico, PhD
- Phone Number: 6487 310-393-0411
- Email: damico@rand.org
Study Contact Backup
- Name: Michael Woodward
- Phone Number: 6595 310-393-0411
- Email: michaelw@rand.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA
-
Los Angeles, California, United States, 90017
- United American Indian Involvement, Inc
-
Santa Monica, California, United States, 90401
- RAND Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Opioid education
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.
|
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.
|
Experimental: TACUNA
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
change from baseline to 3 months
|
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.
|
change from baseline to 6 months
|
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.
|
change from baseline to 12 months
|
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.
|
change from baseline to 3 months
|
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.
|
change from baseline to 6 months
|
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.
|
change from baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
change from baseline to 3 months
|
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).
|
change from baseline to 6 months
|
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).
|
change from baseline to 12 months
|
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).
|
change from baseline to 3 months
|
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).
|
change from baseline to 6 months
|
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).
|
change from baseline to 12 months
|
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.
|
change from baseline to 3 months
|
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.
|
change from baseline to 6 months
|
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.
|
change from baseline to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth D'Amico, PhD, RAND
- Principal Investigator: Daniel Dickerson, DO, MPH, UCLA Integrated Substance Abuse Programs
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4UH3DA050235 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Drinking
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
Boston University Charles River CampusRecruiting
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
-
University of ArkansasRecruitingDrinking Behavior | Drinking Excessive | DrinkingUnited States
-
Butler HospitalNational Institute of General Medical Sciences (NIGMS)CompletedDrinking, AlcoholUnited States
-
Real Prevention, LLCCompletedUnderage Drinking | Alcohol Use, UnderageUnited States
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of North Texas Health Science CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Universidad de GranadaCompletedExercise | Drinking, AlcoholSpain
-
Lehigh UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Brown UniversityCompletedCollege DrinkingUnited States
Clinical Trials on Opioid Education Workshop
-
Washington University School of MedicineRecruiting
-
University of UtahVA Salt Lake City Health Care SystemWithdrawn
-
Hospital for Special Surgery, New YorkWithdrawnACL InjuryUnited States
-
Gerencia de Atención Primaria, MadridActive, not recruitingFear of Falling | Falls | NursingSpain
-
Duke UniversityNot yet recruitingNerve Blocks | Medical Education in Emergency Ultrasound | Medical Education, Simulation, Crisis Resource ManagementUnited States
-
Centre de Recherche de l'Institut Universitaire...Canadian Institutes of Health Research (CIHR); Medical Research Council; Fonds... and other collaboratorsCompletedQuality of Life | Urinary Incontinence | Falls, Accidental | StigmaCanada, France, United Kingdom
-
University of CalgaryCanadian Institutes of Health Research (CIHR)Completed
-
Tehran University of Medical SciencesCompletedTraining Leaflet | Training WorkshopIran, Islamic Republic of
-
National Cancer Center, KoreaSamsung Medical Center; Asan Medical Center; Seoul National University Hospital; Korea University Anam Hospital and other collaboratorsUnknownBreast Cancer | Gastric Cancer | Lung Cancer | Colon CancerKorea, Republic of
-
Kaohsiung Medical University Chung-Ho Memorial...Not yet recruiting