Trial of a Culturally Informed Brief Intervention to Reduce Alcohol Related Health Disparities and Treatment Inequities Among Latinxs

NCT ID: NCT05800899

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2027-06-30

Brief Summary

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This Stage II Randomized Efficacy Trial will compare the effectiveness of a theoretically informed and culturally responsive brief motivational intervention to a non-adapted brief intervention among non-treatment seeking Latinxs admitted for medical treatment of an injury who engage in at risk drinking or were drinking at the time of their injury. The culturally informed brief motivational intervention (CI-BMI) increases autonomous motivation to engage in protective drinking behavior and reduce alcohol problems while addressing barriers to help seeking and facilitating treatment utilization. This project will address the alcohol related health disparities and treatment inequities among Latinx who are more likely to experience alcohol problems yet less likely to receive treatment in order to reduce the negative public health impact of alcohol.

Detailed Description

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Our prior Stage III Randomized Clinical Trial (n=1496) evaluating ethnic differences in response to brief intervention showed that, compared to non-Latinxs Whites, Latinxs were more likely to reduce alcohol use in response to standard brief alcohol interventions that are not adapted to be culturally responsive (NA-BMI) versus treatment as usual1. In Stage I Community Based Participatory Research (Stage I CBPR), we developed a culturally informed brief motivational intervention (CI-BMI) which adopts a harm reduction approach and focuses on reducing alcohol problems and increasing treatment utilization 2. Through a flexible core approach, CI-BMI introduces substantial modifications to standard brief alcohol interventions to be culturally responsive and is theoretically grounded in self-determination theory (SDT)3-5. The result of Stage I CBPR was CI-BMI which 1) leverages cultural values and strengths while addressing the process of acculturation and acculturative stress; 2) is explicitly designed to meet the basic psychological needs of autonomy, relatedness, and competence by supporting autonomy to enhance autonomous motivation to change drinking behavior; and 3) focuses on harm reduction. Our Stage I CBPR (n=87) demonstrated that CIBMI is feasible and acceptable in pretesting in a Level I Trauma Center5. We hypothesize that CI-BMI will lead to increased engagement in protective drinking behaviors, fewer alcohol problems as well as reduce barriers to help seeking and increase treatment utilization among underserved, non-treatment seeking Latinxs who engage in at risk drinking and are seriously injured. The proposed Stage II Efficacy Trial of CI-BMI will randomize 600 Latinxs admitted to a Level I Trauma Center at University Medical Center in El Paso, Texas to either NA-BMI or CI-BMI conducted by research staff from The University of Texas El Paso. Following admission for medical treatment of an injury, eligible Latinx patients will be those who screen positive for drinking at the time of their injury or engage in at risk drinking. The primary aims of the proposed study are to

1\) test the efficacy of CI-BMI in comparison to NA-BMI on alcohol related harm reduction behaviors, alcohol problems, barriers to help seeking and treatment utilization among non-treatment seeking Latinxs and 2) examine the theoretically informed mechanism of behavior change based on SDT including providing autonomy support to meet the basic psychological needs that enhance autonomous motivation. Because the psychological processes underlying the intrasession mechanisms of change remain poorly understood, CI-BMI based on SDT will significantly advance the science and practice of brief interventions6. In addition, planned secondary data analysis will assess the influence of multi-dimensional acculturation/enculturation orientations and acculturative stress on alcohol related outcomes. The results of this study will lead to a theoretically informed and culturally response brief motivation intervention with enhanced generalizability to effectively address alcohol related health disparities and treatment inequities among non-treatment seeking Latinxs.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Research staff conducting the initial assessment prior to randomizations to brief interventions or culturally informed intervention and those conducting follow-up assessments will be blind to participant assignment.

Study Groups

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Brief Motivational Interviewing

Group Type ACTIVE_COMPARATOR

Brief Motivational Interviewing

Intervention Type BEHAVIORAL

Standard non-adapted brief motivational interviewing based on motivational interviewing.

Culturally Adaptation Brief Motivational Interviewing

Group Type EXPERIMENTAL

Culturally adaptation brief motivational interviewing

Intervention Type BEHAVIORAL

culturally adapted brief motivational interviewing based on motivational interviewing.

Interventions

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Brief Motivational Interviewing

Standard non-adapted brief motivational interviewing based on motivational interviewing.

Intervention Type BEHAVIORAL

Culturally adaptation brief motivational interviewing

culturally adapted brief motivational interviewing based on motivational interviewing.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Admission to a level 1 -trauma center
* Involved in a alcohol-related injury
* Self-identify as Latinx
* 18 or older
* Minimum Blood Alcohol Concentration (BAC) score of .001 and/or at risk drinking

Exclusion Criteria

* Traumatic brain injury or otherwise debilitating injury as indicated by a Glasgow Coma Scale score of less than 15.
* Cognitive impairment as indicated by a score of 24 or less on the Mini-Mental Status Exam
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

El Paso County General Hospital dba University Medical Center

UNKNOWN

Sponsor Role collaborator

University of Texas, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Craig Field

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deidra Roach, PhD

Role: STUDY_CHAIR

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Locations

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University Medical Center of El Paso

El Paso, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Craig A Field, PhD

Role: CONTACT

(915) 747-8539

Ashley M Lindquist, B.S.

Role: CONTACT

(909) 675-6516

Facility Contacts

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Sandra Gonzales, MSN

Role: primary

9154727937

Other Identifiers

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UTexasElPaso

Identifier Type: -

Identifier Source: org_study_id

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