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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA022066 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Wellness Gatherings | Active Comparator | 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 + MICUNAY | Experimental | MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICUNAY | Behavioral | MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline to 6 months |
| Number of Participants Who Used Marijuana 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. | change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Consequences of Alcohol Use | 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 from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth D'Amico, PhD | RAND | Principal Investigator |
| Daniel Dickerson, D.O., M.P.H | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United American Indian Involvement, Inc | Los Angeles | California | 90017 | United States | ||
| American Indian Child Resource Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27130360 | Background | D'Amico EJ, Tucker JS, Miles JN, Ewing BA, Shih RA, Pedersen ER. Alcohol and marijuana use trajectories in a diverse longitudinal sample of adolescents: examining use patterns from age 11 to 17 years. Addiction. 2016 Oct;111(10):1825-35. doi: 10.1111/add.13442. Epub 2016 Jun 14. | |
| 14600049 | Background | Ellickson PL, McCaffrey DF, Ghosh-Dastidar B, Longshore DL. New inroads in preventing adolescent drug use: results from a large-scale trial of project ALERT in middle schools. Am J Public Health. 2003 Nov;93(11):1830-6. doi: 10.2105/ajph.93.11.1830. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were aged 14-18 and self-identified as (or parents identified them as) American Indian/Alaska Native.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Asked how old they were. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | American Indian/Alaska Native adolescents aged 14-18. | Posted | Count of Participants | Participants | change from baseline to 6 months |
|
4 years
Total Number of Participants at Risk was 185.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth D'Amico | RAND | 310-393-0411 | 6487 | damico@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2024 | May 9, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2014 | Nov 24, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000074609 | Marijuana Use |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
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| Sacred Path Indigenous Wellness Center |
| OTHER |
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| Community Wellness Gathering | Other | a monthly gathering focused on making healthy choices and learning about Native American culture |
|
| Number of Participants Who Reported Consequences of Marijuana Use | 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. | change from baseline to 6 months |
| Change in Intentions to Use - Alcohol | 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 from baseline to 6 months |
| Change in Intentions to Use - Cigarettes | 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 from baseline to 6 months |
| Change in Intentions to Use - Marijuana | 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 from baseline to 6 months |
| Change in Alcohol Resistance Self-efficacy | 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 from baseline to 6 months |
| Change in Peer Influence - Alcohol | Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often"). | change from baseline to 6 months |
| Change in Peer Influence - Marijuana | Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often"). | change from baseline to 6 months |
| Change in Peer Influence - Cigarettes | Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often"). | change from baseline to 6 months |
| Change in Intentions to Participate in Traditional Practices | 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 from baseline to 6 months |
| Change in Cultural Identification | 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 from baseline to 6 months |
| Change in Spirituality/Happiness | 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 from baseline to 6 months |
| Oakland |
| California |
| 94610 |
| United States |
| 18037603 | Background | D'Amico EJ, Miles JN, Stern SA, Meredith LS. Brief motivational interviewing for teens at risk of substance use consequences: a randomized pilot study in a primary care clinic. J Subst Abuse Treat. 2008 Jul;35(1):53-61. doi: 10.1016/j.jsat.2007.08.008. Epub 2007 Nov 26. |
| Background | Phinney, J. S., & Ong, A. D. (2007). Conceptualization and measurement of ethnic identity: Current status and future directions. Journal of Counseling Psychology, 54(3), 271. |
| Background | Ponterotto, J. G., Gretchen, D., Utsey, S. O., Stracuzzi, T., & Saya Jr, R. (2003). The multigroup ethnic identity measure (MEIM): Psychometric review and further validity testing. Educational and Psychological Measurement, 63(3), 502-515. |
| 27450682 | Background | Brown RA, Dickerson DL, D'Amico EJ. Cultural Identity Among Urban American Indian/Alaska Native Youth: Implications for Alcohol and Drug Use. Prev Sci. 2016 Oct;17(7):852-61. doi: 10.1007/s11121-016-0680-1. |
| 12008794 | Background | Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med. 2002 Winter;24(1):49-58. doi: 10.1207/S15324796ABM2401_06. |
| 33231130 | Derived | Dickerson DL, Parker J, Johnson CL, Brown RA, D'Amico EJ. Recruitment and retention in randomized controlled trials with urban American Indian/Alaska Native adolescents: Challenges and lessons learned. Clin Trials. 2021 Feb;18(1):83-91. doi: 10.1177/1740774520971774. Epub 2020 Nov 24. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Asked participants their gender. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | We ask about a person's ethnicity to create statistics about ethnicity and to present other estimates by ethnic group. | Count of Participants | Participants |
|
| Race (NIH/OMB) | We ask about a person's race to create statistics about race and to present other estimates by race group. | Count of Participants | Participants |
|
| Minimum of Graduated from High School (mother) | We asked study participants via baseline survey if mother was at least a high school graduate. Measure is an indicator of family socioeconomic status. | Count of Participants | Participants |
|
| Minimum of Graduated from High School (father) | We asked study participants via baseline survey if father was at least a high school graduate. Measure is an indicator of family socioeconomic status. | Count of Participants | Participants |
|
| 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. |
|
|
| Primary | Number of Participants Who Used Marijuana 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. | American Indian/Alaska Native adolescents aged 14-18. | Posted | Count of Participants | Participants | change from baseline to 6 months |
|
|
|
| Secondary | Number of Participants Who Reported Consequences of Alcohol Use | 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. | American Indian/Alaska Native adolescents aged 14-18. | Posted | Count of Participants | Participants | change from baseline to 6 months |
|
|
|
| Secondary | Number of Participants Who Reported Consequences of Marijuana Use | 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. | American Indian/Alaska Native adolescents aged 14-18. | Posted | Count of Participants | Participants | change from baseline to 6 months |
|
|
|
| Secondary | Change in Intentions to Use - Alcohol | 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"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Intentions to Use - Cigarettes | 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"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Intentions to Use - Marijuana | 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"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Alcohol Resistance Self-efficacy | 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. | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Peer Influence - Alcohol | Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Peer Influence - Marijuana | Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Peer Influence - Cigarettes | Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Intentions to Participate in Traditional Practices | 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"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Cultural Identification | 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"). | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| Secondary | Change in Spirituality/Happiness | 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. | American Indian/Alaska Native adolescents aged 14-18. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 6 months |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | 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. | 0 | 115 | 0 | 115 | 0 | 115 |
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