NCT03301064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

September 28, 2017

Last Update Submit

January 23, 2024

Conditions

Keywords

alcohol, intervention, Latino, community

Outcome Measures

Primary Outcomes (1)

  • Percentage of heavy drinking days

    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).

    6 months

Secondary Outcomes (1)

  • Average number of standard drinks per week

    6 months

Other Outcomes (1)

  • Drinker Inventory of Negative Consequences (DrINC)

    6 months

Study Arms (2)

Intervention Condition: MET/SBCM

EXPERIMENTAL

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)Other: Alcohol education brochure

Control Condition: Alcohol education brochure

ACTIVE COMPARATOR

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

Interventions

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).

Intervention Condition: MET/SBCM

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

Control Condition: Alcohol education brochureIntervention Condition: MET/SBCM

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Providence Center for Community Improvement

Van Nuys, California, 91405, United States

Location

Providence Health and Services

Wilmington, California, 90744, United States

Location

MeSH Terms

Conditions

Drinking Behavior

Interventions

Motivational InterviewingEthanol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesAlcoholsOrganic Chemicals

Study Officials

  • Mitchell P Karno, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Alison A Moore, MD, MPH

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 4, 2017

Study Start

June 18, 2018

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations