<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03301064</url>
  </required_header>
  <id_info>
    <org_study_id>17-000242</org_study_id>
    <nct_id>NCT03301064</nct_id>
  </id_info>
  <brief_title>Brief Intervention by Community Health Workers for Unhealthy Drinking in Latinos</brief_title>
  <official_title>Brief Intervention by Community Health Workers for Unhealthy Drinking in Latinos</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Providence Health &amp; Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Latinos will comprise nearly 30% of the population by 2050, and socially disadvantaged&#xD;
      Latinos experience a greater burden of poor health and negative social consequences related&#xD;
      to their alcohol use than non-Latino Whites. Despite the need for services, low treatment&#xD;
      utilization rates and poor treatment retention suggest it is important to make alcohol&#xD;
      interventions more accessible for Latinos. Community health workers are an effective way to&#xD;
      help under-served populations manage chronic illnesses such as diabetes and hypertension, but&#xD;
      they have been used very little in addiction services. The current study extends work from a&#xD;
      pilot study that utilized community health workers to deliver a brief alcohol intervention&#xD;
      that integrates Motivational Enhancement Therapy and Strengths-Based Case Management&#xD;
      (MET/SBCM). Based on those promising but preliminary findings, this study will test the&#xD;
      MET/SBCM intervention among a broader population of socially disadvantaged Latinos who engage&#xD;
      in unhealthy drinking. For the study a partnership will be formed between the University of&#xD;
      California, Los Angeles (UCLA) and a large community-based healthcare organization,&#xD;
      Providence Center for Community Health Improvement to conduct a randomized controlled trial&#xD;
      of the MET/SBCM intervention.&#xD;
&#xD;
      Participants (n=234) will screen positive for exceeding US low-risk drinking guidelines and&#xD;
      will not be seeking alcohol treatment. They will be randomized to either the 3-session&#xD;
      MET/SBCM alcohol intervention or to an alcohol brochure control condition. Alcohol use,&#xD;
      alcohol-related problems and utilization of health and social services will be assessed at&#xD;
      baseline, 3-, 6- and 12-month follow-ups. It is predicted that the MET/SBCM intervention will&#xD;
      improve outcomes compared to the control group. The study will also examine the extent to&#xD;
      which changes in drinking were preceded by improvements in readiness to change, perceived&#xD;
      benefits and risks associated with alcohol use, perception of drinking norms, use of&#xD;
      pro-change language during intervention sessions, belief in one's ability to change,&#xD;
      self-esteem and use of community services.&#xD;
&#xD;
      The goal of this project is to establish an evidence base for an intervention approach that&#xD;
      is sustainable by a large community-based organization serving Latinos. Working with&#xD;
      community health workers poises this intervention to address health disparities within this&#xD;
      community. The project will help improve the reach and impact of effective alcohol&#xD;
      interventions among socially disadvantaged Latinos, thereby contributing to improved&#xD;
      population health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Latinos will comprise nearly 30% of the population by 2050, and socially disadvantaged&#xD;
      Latinos experience a greater burden of poor health and negative social consequences related&#xD;
      to their alcohol use than non-Latino Whites. The burden of poor health related to alcohol use&#xD;
      also suggests the need for early identification and intervention before alcohol use&#xD;
      progresses to a more serious condition requiring intensive treatment. Despite the need for&#xD;
      services, low treatment utilization rates and poor treatment retention suggest it is&#xD;
      important to make alcohol interventions more accessible for Latinos. Spanish-language&#xD;
      motivational interventions have been shown to reduce heavy drinking in diverse populations,&#xD;
      yet access to these types of interventions remains a limitation. Community health workers are&#xD;
      an effective way to help under-served populations manage chronic illnesses such as diabetes&#xD;
      and hypertension, but they have been used very little in addiction services. Preliminary&#xD;
      evidence from a randomized pilot trial suggested that an intervention integrating&#xD;
      Motivational Enhancement Therapy and Strengths Based Case Management (hereafter referred to&#xD;
      as MET/SBCM) led to greater reductions in alcohol use compared to a brief feedback condition&#xD;
      among socially disadvantaged Spanish speaking Latino male day laborers who were heavy&#xD;
      drinkers. Multi-level interventions such as MET/SBCM that target the complex individual- and&#xD;
      community-level needs for health-disparities populations are highly recommended as a strategy&#xD;
      to improve population health. In that pilot trial the MET/SBCM intervention was provided in&#xD;
      Spanish by community health workers (promotores) with high fidelity and participants reported&#xD;
      high treatment satisfaction. The results are encouraging for moving forward with additional&#xD;
      efforts to study alcohol interventions delivered by community health workers. Based on these&#xD;
      promising but preliminary findings, we propose to test the multi-level MET/SBCM intervention&#xD;
      targeting a broader population of socially disadvantaged Latinos who engage in unhealthy&#xD;
      drinking. For the proposed study a partnership will be formed between UCLA and a large&#xD;
      community-based healthcare organization, Providence Center for Community Health Improvement&#xD;
      (Providence) to conduct a phase 2 randomized controlled trial. Providence has a well&#xD;
      established Latino Health Promoter Program that serves a large population of Latinos, most of&#xD;
      whom have low income, low education status and limited English proficiency. The MET-SBCM&#xD;
      intervention, to be conducted by promotores at Providence, is thus poised to provide Latinos&#xD;
      access to a needed health service for unhealthy alcohol use. If successful, the study will&#xD;
      extend the potential reach and impact of brief alcohol intervention for Latinos in the&#xD;
      general population.&#xD;
&#xD;
      Primary Aim #1 is to determine the efficacy of the MET/SBCM intervention compared to an&#xD;
      educational booklet control condition in reducing alcohol use and alcohol-related problems&#xD;
      among Latinos who report exceeding US low-risk drinking guidelines (for men: 5 or more drinks&#xD;
      weekly or 15 or more drinks in a given week; for women: 4 or more drinks weekly or 8 or more&#xD;
      drinks in a given week).&#xD;
&#xD;
      Hypothesis 1: Participants assigned to a 3-session MET/SBCM intervention will show decreases&#xD;
      in the average drinks consumed per week, the frequency of heavy drinking days, and&#xD;
      alcohol-related problems at 3-, 6-, and 12-month follow-ups compared to participants assigned&#xD;
      to the educational booklet control condition.&#xD;
&#xD;
      Primary Aim #2 is to determine the efficacy of the MET/SBCM intervention in increasing&#xD;
      utilization of community services (e.g., job services, housing assistance, food assistance,&#xD;
      mental health services) among Latinos who report exceeding US low-risk drinking guidelines.&#xD;
&#xD;
      Hypothesis 2: Participants assigned to the MET/SBCM intervention will utilize more types of&#xD;
      services by the 3-, 6-, and 12-month follow-ups compared to participants assigned to the&#xD;
      educational booklet control condition.&#xD;
&#xD;
      Primary Aim #3 is to examine mechanisms of behavior change underlying observed MET/SBCM&#xD;
      intervention effects on alcohol use (or in the event the intervention is not effective, to&#xD;
      identify negative findings in the causal chains). Candidate mechanisms are selected based on&#xD;
      theory and the extant literature on brief motivation-based interventions and strengths-based&#xD;
      case management. The mechanisms will include (1) readiness to change, (2) perceived reward&#xD;
      value and risks associated with alcohol use, (3) perception of drinking norms, (4) change&#xD;
      talk, (5) general self-efficacy, (6) self-esteem and (7) utilization of community services.&#xD;
      We predict that changes in these mechanisms by the 3-month follow-up will mediate the effects&#xD;
      of the intervention on average drinks per week at the 6- and 12-months follow-ups.&#xD;
&#xD;
      The overarching goal of this project is to establish an evidence base for an intervention&#xD;
      approach that is ultimately sustainable by a large community-based organization serving&#xD;
      Latinos. Working with community health workers positions this intervention to address larger&#xD;
      health disparities within this community. The project is significant in its efforts to&#xD;
      improve the reach and impact of effective alcohol interventions among socially disadvantaged&#xD;
      Latinos, thereby contributing to improved population health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2018</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is a phase 2 randomized controlled trial to determine the efficacy of a 3-session intervention that combines Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM) to reduce unhealthy alcohol use. Participants (n=234) will be block randomized to either the MET/SBCM intervention or to a control condition that receives an educational brochure about alcohol and its associated risks. Both the MET/SBCM intervention and the control condition (i.e., the educational brochure) will be provided by promotores who work for the Providence Center for Community Improvement in Los Angeles, California. Participants will be Latinos served by Providence's outreach programs who exceed low-risk drinking guidelines.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of heavy drinking days</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of days on which participants drank heavily in the past 90 days, as defined by NIAAA guidelines (&gt;=5 drinks for men; &gt;=4 drinks for women).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average number of standard drinks per week</measure>
    <time_frame>6 months</time_frame>
    <description>Average number of standard drinks per week in the past 90 days.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Drinker Inventory of Negative Consequences (DrINC)</measure>
    <time_frame>6 months</time_frame>
    <description>Negative consequences associated with alcohol use will include the domains of physical, interpersonal, intrapersonal, impulse control and social responsibility problems. The primary measure of consequences will be the total score across all 5 domains.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">237</enrollment>
  <condition>Drinking Heavy</condition>
  <condition>Drinking Behavior</condition>
  <condition>Drinking Excessive</condition>
  <arm_group>
    <arm_group_label>Intervention Condition: MET/SBCM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The combined Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM) intervention will be used in the proposed study. The intervention consists of three 1-hour sessions. The sessions are structured to provide feedback to participants about their risks associated with alcohol use and to help them identify barriers and motivators to change. The sessions will aim to reduce drinking by promoting self-efficacy to change, setting goals and fostering utilization of medical, mental health and social services as needed. A comprehensive list of referrals will be provided. Sessions will occur 1-2 weeks apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Condition: Alcohol education brochure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the control condition will be receive a Spanish-language version of an alcohol education brochure. Participants will be encouraged to read the brochure. The brochure will provide information about defining heavy drinking, harmful effects of drinking and symptoms of an alcohol use disorder. Control group participants will also receive a list of available clinics and resources from Providence staff. After the baseline visit participants in the control group will be contacted by phone twice over the next 4 weeks by the promotores to remind them about the 3-month follow-up appointment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM)</intervention_name>
    <description>Key objectives of the intervention are as follows: (1) identify health and personal goals and develop discrepancies between goals and current actions, (2) provide feedback related to risks associated with the participant's drinking (e.g., driving after drinking, liver disease), (3) provide normative feedback about the participant's pattern of drinking to alcohol use in the US among Latinos in the participant's age and gender group, (4) discuss reasons for drinking (e.g., feeling isolated from family, machismo, low status employment), (5) weigh the pros and cons of drinking and reasons to reduce drinking (e.g., to better provide for the family, improving family relationships), (6) negotiate a plan for reducing drinking and/or seeking help, (7) recognize personal strengths in the process of change (e.g., religiosity, desire to provide for family), and (8) identify needed social and health services and explore potential barriers (e.g., transportation).</description>
    <arm_group_label>Intervention Condition: MET/SBCM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alcohol education brochure</intervention_name>
    <description>The alcohol education brochure will address health risks associated with alcohol use and will provide information on low-risk drinking.</description>
    <arm_group_label>Control Condition: Alcohol education brochure</arm_group_label>
    <arm_group_label>Intervention Condition: MET/SBCM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Latino ethnicity&#xD;
&#xD;
          -  aged 21 years or older&#xD;
&#xD;
          -  speak Spanish (monolingual Spanish or bilingual Spanish and English)&#xD;
&#xD;
          -  exceeding low-risk drinking guidelines set by the NIH/NIAAA (for men: 15 or more&#xD;
             drinks per week or 5 or more drinks on an occasion weekly in the past month; for&#xD;
             women: consuming 8 or more drinks per week or 4 or more drinks on an occasion weekly&#xD;
             in the past month)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  seeking treatment for alcohol problems&#xD;
&#xD;
          -  any alcohol treatment in the past 30 days&#xD;
&#xD;
          -  serious alcohol withdrawal symptoms as indicated by a score of 10 or higher on the&#xD;
             Clinical Institute Withdrawal Assessment for Alcohol-Revised&#xD;
&#xD;
          -  substantial problems associated with illicit drug use as indicated by a score of 6 or&#xD;
             higher on the Drug Abuse Screening Test (DAST-10)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitchell P Karno, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alison A Moore, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Providence Center for Community Improvement</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health and Services</name>
      <address>
        <city>Wilmington</city>
        <state>California</state>
        <zip>90744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Mitchell Karno, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>alcohol, intervention, Latino, community</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drinking Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03301064
org study id: 17-000242
nct id: NCT03301064
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Latinos will comprise nearly 30% of the population by 2050, and socially disadvantaged
      Latinos experience a greater burden of poor health and negative social consequences related
      to their alcohol use than non-Latino Whites. Despite the need for services, low treatment
      utilization rates and poor treatment retention suggest it is important to make alcohol
      interventions more accessible for Latinos. Community health workers are an effective way to
      help under-served populations manage chronic illnesses such as diabetes and hypertension, but
      they have been used very little in addiction services. The current study extends work from a
      pilot study that utilized community health workers to deliver a brief alcohol intervention
      that integrates Motivational Enhancement Therapy and Strengths-Based Case Management
      (MET/SBCM). Based on those promising but preliminary findings, this study will test the
      MET/SBCM intervention among a broader population of socially disadvantaged Latinos who engage
      in unhealthy drinking. For the study a partnership will be formed between the University of
      California, Los Angeles (UCLA) and a large community-based healthcare organization,
      Providence Center for Community Health Improvement to conduct a randomized controlled trial
      of the MET/SBCM intervention.

      Participants (n=234) will screen positive for exceeding US low-risk drinking guidelines and
      will not be seeking alcohol treatment. They will be randomized to either the 3-session
      MET/SBCM alcohol intervention or to an alcohol brochure control condition. Alcohol use,
      alcohol-related problems and utilization of health and social services will be assessed at
      baseline, 3-, 6- and 12-month follow-ups. It is predicted that the MET/SBCM intervention will
      improve outcomes compared to the control group. The study will also examine the extent to
      which changes in drinking were preceded by improvements in readiness to change, perceived
      benefits and risks associated with alcohol use, perception of drinking norms, use of
      pro-change language during intervention sessions, belief in one's ability to change,
      self-esteem and use of community services.

      The goal of this project is to establish an evidence base for an intervention approach that
      is sustainable by a large community-based organization serving Latinos. Working with
      community health workers poises this intervention to address health disparities within this
      community. The project will help improve the reach and impact of effective alcohol
      interventions among socially disadvantaged Latinos, thereby contributing to improved
      population health.
Latinos will comprise nearly 30% of the population by 2050, and socially disadvantaged
      Latinos experience a greater burden of poor health and negative social consequences related
      to their alcohol use than non-Latino Whites. The burden of poor health related to alcohol use
      also suggests the need for early identification and intervention before alcohol use
      progresses to a more serious condition requiring intensive treatment. Despite the need for
      services, low treatment utilization rates and poor treatment retention suggest it is
      important to make alcohol interventions more accessible for Latinos. Spanish-language
      motivational interventions have been shown to reduce heavy drinking in diverse populations,
      yet access to these types of interventions remains a limitation. Community health workers are
      an effective way to help under-served populations manage chronic illnesses such as diabetes
      and hypertension, but they have been used very little in addiction services. Preliminary
      evidence from a randomized pilot trial suggested that an intervention integrating
      Motivational Enhancement Therapy and Strengths Based Case Management (hereafter referred to
      as MET/SBCM) led to greater reductions in alcohol use compared to a brief feedback condition
      among socially disadvantaged Spanish speaking Latino male day laborers who were heavy
      drinkers. Multi-level interventions such as MET/SBCM that target the complex individual- and
      community-level needs for health-disparities populations are highly recommended as a strategy
      to improve population health. In that pilot trial the MET/SBCM intervention was provided in
      Spanish by community health workers (promotores) with high fidelity and participants reported
      high treatment satisfaction. The results are encouraging for moving forward with additional
      efforts to study alcohol interventions delivered by community health workers. Based on these
      promising but preliminary findings, we propose to test the multi-level MET/SBCM intervention
      targeting a broader population of socially disadvantaged Latinos who engage in unhealthy
      drinking. For the proposed study a partnership will be formed between UCLA and a large
      community-based healthcare organization, Providence Center for Community Health Improvement
      (Providence) to conduct a phase 2 randomized controlled trial. Providence has a well
      established Latino Health Promoter Program that serves a large population of Latinos, most of
      whom have low income, low education status and limited English proficiency. The MET-SBCM
      intervention, to be conducted by promotores at Providence, is thus poised to provide Latinos
      access to a needed health service for unhealthy alcohol use. If successful, the study will
      extend the potential reach and impact of brief alcohol intervention for Latinos in the
      general population.

      Primary Aim #1 is to determine the efficacy of the MET/SBCM intervention compared to an
      educational booklet control condition in reducing alcohol use and alcohol-related problems
      among Latinos who report exceeding US low-risk drinking guidelines (for men: 5 or more drinks
      weekly or 15 or more drinks in a given week; for women: 4 or more drinks weekly or 8 or more
      drinks in a given week).

      Hypothesis 1: Participants assigned to a 3-session MET/SBCM intervention will show decreases
      in the average drinks consumed per week, the frequency of heavy drinking days, and
      alcohol-related problems at 3-, 6-, and 12-month follow-ups compared to participants assigned
      to the educational booklet control condition.

      Primary Aim #2 is to determine the efficacy of the MET/SBCM intervention in increasing
      utilization of community services (e.g., job services, housing assistance, food assistance,
      mental health services) among Latinos who report exceeding US low-risk drinking guidelines.

      Hypothesis 2: Participants assigned to the MET/SBCM intervention will utilize more types of
      services by the 3-, 6-, and 12-month follow-ups compared to participants assigned to the
      educational booklet control condition.

      Primary Aim #3 is to examine mechanisms of behavior change underlying observed MET/SBCM
      intervention effects on alcohol use (or in the event the intervention is not effective, to
      identify negative findings in the causal chains). Candidate mechanisms are selected based on
      theory and the extant literature on brief motivation-based interventions and strengths-based
      case management. The mechanisms will include (1) readiness to change, (2) perceived reward
      value and risks associated with alcohol use, (3) perception of drinking norms, (4) change
      talk, (5) general self-efficacy, (6) self-esteem and (7) utilization of community services.
      We predict that changes in these mechanisms by the 3-month follow-up will mediate the effects
      of the intervention on average drinks per week at the 6- and 12-months follow-ups.

      The overarching goal of this project is to establish an evidence base for an intervention
      approach that is ultimately sustainable by a large community-based organization serving
      Latinos. Working with community health workers positions this intervention to address larger
      health disparities within this community. The project is significant in its efforts to
      improve the reach and impact of effective alcohol interventions among socially disadvantaged
      Latinos, thereby contributing to improved population health.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a phase 2 randomized controlled trial to determine the efficacy of a 3-session intervention that combines Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM) to reduce unhealthy alcohol use. Participants (n=234) will be block randomized to either the MET/SBCM intervention or to a control condition that receives an educational brochure about alcohol and its associated risks. Both the MET/SBCM intervention and the control condition (i.e., the educational brochure) will be provided by promotores who work for the Providence Center for Community Improvement in Los Angeles, California. Participants will be Latinos served by Providence's outreach programs who exceed low-risk drinking guidelines.
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of heavy drinking days
time frame: 6 months
description: Percentage of days on which participants drank heavily in the past 90 days, as defined by NIAAA guidelines (>=5 drinks for men; >=4 drinks for women).
measure: Average number of standard drinks per week
time frame: 6 months
description: Average number of standard drinks per week in the past 90 days.
measure: Drinker Inventory of Negative Consequences (DrINC)
time frame: 6 months
description: Negative consequences associated with alcohol use will include the domains of physical, interpersonal, intrapersonal, impulse control and social responsibility problems. The primary measure of consequences will be the total score across all 5 domains.
arm group label: Intervention Condition: MET/SBCM
arm group type: Experimental
description: The combined Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM) intervention will be used in the proposed study. The intervention consists of three 1-hour sessions. The sessions are structured to provide feedback to participants about their risks associated with alcohol use and to help them identify barriers and motivators to change. The sessions will aim to reduce drinking by promoting self-efficacy to change, setting goals and fostering utilization of medical, mental health and social services as needed. A comprehensive list of referrals will be provided. Sessions will occur 1-2 weeks apart.
arm group label: Control Condition: Alcohol education brochure
arm group type: Active Comparator
description: Participants randomized to the control condition will be receive a Spanish-language version of an alcohol education brochure. Participants will be encouraged to read the brochure. The brochure will provide information about defining heavy drinking, harmful effects of drinking and symptoms of an alcohol use disorder. Control group participants will also receive a list of available clinics and resources from Providence staff. After the baseline visit participants in the control group will be contacted by phone twice over the next 4 weeks by the promotores to remind them about the 3-month follow-up appointment.
intervention type: Behavioral
intervention name: Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM)
description: Key objectives of the intervention are as follows: (1) identify health and personal goals and develop discrepancies between goals and current actions, (2) provide feedback related to risks associated with the participant's drinking (e.g., driving after drinking, liver disease), (3) provide normative feedback about the participant's pattern of drinking to alcohol use in the US among Latinos in the participant's age and gender group, (4) discuss reasons for drinking (e.g., feeling isolated from family, machismo, low status employment), (5) weigh the pros and cons of drinking and reasons to reduce drinking (e.g., to better provide for the family, improving family relationships), (6) negotiate a plan for reducing drinking and/or seeking help, (7) recognize personal strengths in the process of change (e.g., religiosity, desire to provide for family), and (8) identify needed social and health services and explore potential barriers (e.g., transportation).
arm group label: Intervention Condition: MET/SBCM
intervention type: Other
intervention name: Alcohol education brochure
description: The alcohol education brochure will address health risks associated with alcohol use and will provide information on low-risk drinking.
arm group label: Control Condition: Alcohol education brochure
arm group label: Intervention Condition: MET/SBCM
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Mitchell P Karno, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Alison A Moore, MD, MPH
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Mitchell Karno, PhD
investigator title: Principal Investigator
mesh term: Drinking Behavior
sharing ipd: No