Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03301064 |
| Other study ID # |
17-000242 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 18, 2018 |
| Est. completion date |
March 15, 2021 |
Study information
| Verified date |
January 2024 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
