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Brief Intervention by Community Health Workers for Unhealthy Drinking in Latinos

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ClinicalTrials.gov Identifier: NCT03301064
Recruitment Status : Not yet recruiting
First Posted : October 4, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
University of California, San Diego
Providence Health & Services
Northeastern University
Information provided by (Responsible Party):
Mitchell Karno, PhD, University of California, Los Angeles

Brief Summary:

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=260) 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.


Condition or disease Intervention/treatment Phase
Drinking Heavy Drinking Behavior Drinking Excessive Behavioral: Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM) Other: Alcohol education brochure Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
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=260) 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Intervention by Community Health Workers for Unhealthy Drinking in Latinos
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: Intervention Condition: MET/SBCM
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.
Behavioral: Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM)
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).

Other: Alcohol education brochure
The alcohol education brochure will address health risks associated with alcohol use and will provide information on low-risk drinking.

Active Comparator: Control Condition: Alcohol education brochure
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.
Other: Alcohol education brochure
The alcohol education brochure will address health risks associated with alcohol use and will provide information on low-risk drinking.




Primary Outcome Measures :
  1. Percentage of heavy drinking days [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. Average number of standard drinks per week [ Time Frame: 1 year ]
    Average number of standard drinks per week in the past 90 days.


Other Outcome Measures:
  1. Drinker Inventory of Negative Consequences (DrINC) [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Latino ethnicity
  • aged 21 years or older
  • speak Spanish (monolingual Spanish or bilingual Spanish and English)
  • exceeding low-risk drinking guidelines set by the NIH/NIAAA (for men: 15 or more drinks per week or 5 or more drinks on an occasion weekly in the past month; for women: consuming 8 or more drinks per week or 4 or more drinks on an occasion weekly in the past month)

Exclusion Criteria

  • seeking treatment for alcohol problems
  • any alcohol treatment in the past 30 days
  • serious alcohol withdrawal symptoms as indicated by a score of 10 or higher on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
  • substantial problems associated with illicit drug use as indicated by a score of 6 or higher on the Drug Abuse Screening Test (DAST-10)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301064


Contacts
Contact: Blanca X. Dominguez, MPH 213-718-1649 bdominguez@mednet.ucla.edu
Contact: Juan Mendez, BS 310-303-5086

Sponsors and Collaborators
University of California, Los Angeles
University of California, San Diego
Providence Health & Services
Northeastern University
Investigators
Principal Investigator: Mitchell P Karno, PhD University of California, Los Angeles
Principal Investigator: Alison A Moore, MD, MPH University of California, San Diego

Responsible Party: Mitchell Karno, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03301064     History of Changes
Other Study ID Numbers: 17-000242
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mitchell Karno, PhD, University of California, Los Angeles:
alcohol, intervention, Latino, community

Additional relevant MeSH terms:
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs