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Recruiting NCT05800899

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

No phase Interventional Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief Motivational Interviewing, Culturally adaptation brief motivational interviewing.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Behavioral Brief Motivational Interviewing
    Standard non-adapted brief motivational interviewing based on motivational interviewing.
  • Behavioral Culturally adaptation brief motivational interviewing
    culturally adapted brief motivational interviewing based on motivational interviewing.

Primary outcome measures

  • Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 3-month [Time frame: Baseline and 3 month]
  • Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 6-month [Time frame: Baseline and 6 month]
  • Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 12-month [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline and 12-month]
Secondary outcome measures (6)
  • Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 3 months [Time frame: Baseline and 3-month]
  • Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 6 months [Time frame: Baseline and 6-month]
  • Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 12 months [Time frame: 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 [Time frame: 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 [Time frame: Baseline and 6-month]
  • change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 12 months [Time frame: Baseline and 12-month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University Medical Center of El Paso — El Paso

Identifiers

NCT: NCT05800899 · UTexasElPaso

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗