Clinical trial NCT05800899: Trial of a Culturally Informed Brief Intervention to Reduce Alcohol Related Health Disparities and Treatment Inequities Among Latinxs
Official title: Stage II Efficacy Trial of a Culturally Informed Brief Intervention to Reduce Alcohol Related Health Disparities and Treatment Inequities Among Latinxs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Brief Motivational Intervention
Cultural Adaptation
Mechanisms of Change
Self-Determination Theory
Harm Reduction
Alcohol Use Disorder
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: El Paso County General Hospital dba University Medical Center
First posted: 2023-04-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 3-month
timeFrame: Baseline and 3 month
measure: Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 6-month
timeFrame: Baseline and 6 month
measure: Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 12-month
timeFrame: Baseline and 12 month
measure: change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 3 months
timeFrame: Baseline and 3 month
measure: change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 6 months
timeFrame: Baseline and 6 month
measure: change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 12 months
timeFrame: Baseline and 12-month
Secondary outcomes:
measure: Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 3 months
timeFrame: Baseline and 3-month
measure: Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 6 months
timeFrame: Baseline and 6-month
measure: Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 12 months
timeFrame: Baseline and 12-month
measure: change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 3 months
timeFrame: Baseline and 3-month
measure: change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 6 months
timeFrame: Baseline and 6-month
measure: change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 12 months
timeFrame: Baseline and 12-month
Other outcomes:
measure: Change from baseline in quality of life using the World Health Organization Quality of Life (WHOQoL) at 6 months
timeFrame: Baseline and 6-month
measure: change from baseline in Basic psychological needs will be assessed using Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) at 3 months
timeFrame: Baseline and 3-month
measure: change from baseline in Basic psychological needs will be assessed using Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) at 3 months
timeFrame: Baseline and 6-month
measure: change from baseline in Basic psychological needs will be assessed using Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF) at 12 months
timeFrame: Baseline and 12-month
measure: Changes in drinking from baseline using the Drinking Behavior Regulatory Style Questionnaire at 3 month.
timeFrame: Baseline and 3-month
measure: Changes in drinking from baseline using the Drinking Behavior Regulatory Style Questionnaire at 6 month.
timeFrame: Baseline and 6-month
measure: Changes in drinking from baseline using the Drinking Behavior Regulatory Style Questionnaire at 12 month.
timeFrame: Baseline and 12-month
Locations:
city: El Paso
country: United States
facility: University Medical Center of El Paso
state: Texas
Study officials:
affiliation: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Deidra Roach, PhD
role: STUDY_CHAIR
References: