Alcohol UseMICUNAYNCT02290938
Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY)
A study testing MICUNAY and Community Wellness Gathering in people with Alcohol Use and Marijuana Use, run by RAND at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Marijuana Use
- What is being tested?
- MICUNAY and Community Wellness Gathering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- identify as Native American
- age 14-18
Who cannot join
- just need to meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
United American Indian Involvement, Inc
Los Angeles, California, 90017
American Indian Child Resource Center
Oakland, California, 94610
About this study
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.
Read the detailed description
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.
- Conditions
- Alcohol Use, Marijuana Use
- Being tested
- MICUNAY, Community Wellness Gathering
- Keywords
- adolescents, Native American, alcohol use, drug use, cultural, traditional activities, cultural identification
- Medical subject headings
- Alcohol Drinking, Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICUNAYBehavioural
MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Community Wellness GatheringOther
a monthly gathering focused on making healthy choices and learning about Native American culture
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Community Wellness Gathering |
| 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. Receives: Behavioral: MICUNAY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: change from baseline to 6 months
Secondary outcomes (12)
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.
Measured: change from baseline to 6 months
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.
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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.
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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").
Measured: 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.
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), University of California, Los Angeles, Sacred Path Indigenous Wellness Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth D'Amico, PhD, Principal investigator, RANDDaniel Dickerson, D.O., M.P.H, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290938
- Sponsor's protocol ID
- 1R01AA022066
- Other IDs
- 1R01AA022066
- Acronym
- MICUNAY
- Status last verified
- Jun 2024
- First submitted
- 10 Jul 2014
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27130360Ellickson 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.
PubMed 14600049D'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.
PubMed 18037603Phinney, J. S., & Ong, A. D. (2007). Conceptualization and measurement of ethnic identity: Current status and future directions. Journal of Counseling Psychology, 54(3), 271.
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.
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.
PubMed 27450682Peterman 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.
PubMed 12008794Dickerson 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.
PubMed 33231130
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY)
- ClinicalTrials.gov ID
- NCT02290938
- Acronym / sponsor ID
- MICUNAY / 1R01AA022066
- Conditions
- Alcohol Use, Marijuana Use
- Keywords
- adolescents, Native American, alcohol use, drug use, cultural, traditional activities, cultural identification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), University of California, Los Angeles, Sacred Path Indigenous Wellness Center
- Study start
- Jul 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Wellness Gatherings | Active comparator | Other: Community Wellness GatheringAll 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 | Behavioral: MICUNAYMICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- identify as Native American
- age 14-18
Key exclusion criteria (1 listed)
- just need to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICUNAYMICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. | Behavioural | Community Wellness Gathering + MICUNAY |
| Community Wellness Gatheringa monthly gathering focused on making healthy choices and learning about Native American culture | Other | Community Wellness Gatherings |
Primary outcome
Number of Participants Who Used Alcohol From Baseline to 6 Months
Time frame: change 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.
Number of Participants Who Used Marijuana From Baseline to 6 Months
Time frame: change 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.
12 secondary outcomes
Number of Participants Who Reported Consequences of Alcohol Use
Time frame: change from baseline to 6 months
Number of Participants Who Reported Consequences of Marijuana Use
Time frame: change from baseline to 6 months
Change in Intentions to Use - Alcohol
Time frame: change from baseline to 6 months
Change in Intentions to Use - Cigarettes
Time frame: change from baseline to 6 months
Change in Intentions to Use - Marijuana
Time frame: change from baseline to 6 months
Change in Alcohol Resistance Self-efficacy
Time frame: change from baseline to 6 months
Change in Peer Influence - Alcohol
Time frame: change from baseline to 6 months
Change in Peer Influence - Marijuana
Time frame: change from baseline to 6 months
Change in Peer Influence - Cigarettes
Time frame: change from baseline to 6 months
Change in Intentions to Participate in Traditional Practices
Time frame: change from baseline to 6 months
Change in Cultural Identification
Time frame: change from baseline to 6 months
Change in Spirituality/Happiness
Time frame: change from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27130360D'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.
- Background: PubMed 14600049Ellickson 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.
- Background: PubMed 18037603D'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.
- BackgroundPhinney, J. S., & Ong, A. D. (2007). Conceptualization and measurement of ethnic identity: Current status and future directions. Journal of Counseling Psychology, 54(3), 271.
- BackgroundPonterotto, 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.
- Background: PubMed 27450682Brown 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.
- Background: PubMed 12008794Peterman 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.
- Derived from this study: PubMed 33231130Dickerson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth D'Amico, PhD principal investigator
RAND
Daniel Dickerson, D.O., M.P.H principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICUNAY and Community Wellness Gathering in people with Alcohol Use and Marijuana Use, run by RAND at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Used Alcohol From Baseline to 6 Months (time frame: change from baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290938, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.