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

NCT05800899 | Recruiting

• 1 other identifier: UTexasElPaso
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

Brief Motivational Intervention; Cultural Adaptation; Mechanisms of Change; Self-Determination Theory; Harm Reduction; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (6)

• Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 3-month

  The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(3 month -baseline score)

  Baseline and 3 month

• Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 6-month

  The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(6 month -baseline score)

  Baseline and 6 month

• Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 12-month

  The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(12 month -baseline score)

  Baseline and 12 month

• change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 3 months

  Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (3-month -baseline score)

  Baseline and 3 month

• change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 6 months

  Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (6 -month -baseline score)

  Baseline and 6 month

• change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 12 months

  Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (12-month -baseline score)

  Baseline and 12-month

Secondary Outcomes (6)

• Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 3 months

  Baseline and 3-month

• Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 6 months

  Baseline and 6-month

• Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 12 months

  Baseline and 12-month

• change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 3 months

  Baseline and 3-month

• change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 6 months

  Baseline and 6-month

Other Outcomes (7)

• Change from baseline in quality of life using the World Health Organization Quality of Life (WHOQoL) at 6 months

  Baseline and 6-month

• change from baseline in Basic psychological needs will be assessed using Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) at 3 months

  Baseline and 3-month

• change from baseline in Basic psychological needs will be assessed using Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) at 3 months

  Baseline and 6-month

Study Arms (2)

Brief Motivational Interviewing

ACTIVE COMPARATOR

Behavioral: Brief Motivational Interviewing

Culturally Adaptation Brief Motivational Interviewing

EXPERIMENTAL

Behavioral: Culturally adaptation brief motivational interviewing

Interventions

Brief Motivational Interviewing BEHAVIORAL

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

Brief Motivational Interviewing

Culturally adaptation brief motivational interviewing BEHAVIORAL

culturally adapted brief motivational interviewing based on motivational interviewing.

Culturally Adaptation Brief Motivational Interviewing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas, El Paso: lead
• University of Texas at Austin: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• El Paso County General Hospital dba University Medical Center: collaborator

Study Sites (1)

University Medical Center of El Paso

El Paso, Texas, 79905, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Harm Reduction

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Deidra Roach, PhD

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  STUDY CHAIR

Central Study Contacts

Craig A Field, PhD

CONTACT

(915) 747-8539; cfield@utep.edu

Ashley M Lindquist, B.S.

CONTACT

(909) 675-6516; amlindquist@miners.utep.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 6, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: NIAAA automatically makes study information and data available two years after the study completion date.
• Access Criteria: In order to access NIAAA data sharing, users must be an authorized Researcher Auth Service (RAS)

Locations

US (1)