Clinical trial NCT03301064: Brief Intervention by Community Health Workers for Unhealthy Drinking in Latinos
Official title: Brief Intervention by Community Health Workers for Unhealthy Drinking in Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drinking Heavy
Drinking Behavior
Drinking Excessive
Keywords: alcohol, intervention, Latino, community
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Providence Health & Services
name: Boston University
First posted: 2017-10-04
Enrollment: 237
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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=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-, and 6-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.

Detailed description: 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- and 6-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- and 6-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-month follow-up.

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.

Eligibility 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)

Primary outcomes:
measure: Percentage of heavy drinking days
timeFrame: 6 months
Secondary outcomes:
measure: Average number of standard drinks per week
timeFrame: 6 months
Other outcomes:
measure: Drinker Inventory of Negative Consequences (DrINC)
timeFrame: 6 months
Locations:
city: Van Nuys
country: United States
facility: Providence Center for Community Improvement
state: California
city: Wilmington
country: United States
facility: Providence Health and Services
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Mitchell P Karno, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Alison A Moore, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: