AzTrials
AzTrials

Alcohol Use DisorderNCT05800899

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

A study testing Brief Motivational Interviewing and Culturally adaptation brief motivational interviewing in people with Alcohol Use Disorder, run by University of Texas, El Paso at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Brief Motivational Interviewing and Culturally adaptation brief motivational interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
30 Jun 2023to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Craig A Field, PhD contact

(915) 747-8539

cfield@utep.edu

Ashley M Lindquist, B.S. contact

(909) 675-6516

amlindquist@miners.utep.edu

United States1 site, 1 recruiting
  • University Medical Center of El Paso

    El Paso, Texas, 79905

    Sandra Gonzales, MSN, 9154727937, sandra.gonzalez@umcelpaso.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.
Being tested
Brief Motivational Interviewing, Culturally adaptation brief motivational interviewing
Keywords
Brief Motivational Intervention, Cultural Adaptation, Mechanisms of Change, Self-Determination Theory, Harm Reduction, Alcohol Use Disorder
Medical subject headings
Alcoholism, Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Motivational InterviewingBehavioural

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

  • Culturally adaptation brief motivational interviewingBehavioural

    culturally adapted brief motivational interviewing based on motivational interviewing.

Study groups in NCT05800899
Study groupRoleWhat they receive
Brief Motivational InterviewingActive comparatorNot described
Receives: Behavioral: Brief Motivational Interviewing
Culturally Adaptation Brief Motivational InterviewingExperimentalNot described
Receives: Behavioral: Culturally adaptation brief motivational interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline and 3 month

  2. 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)

    Measured: Baseline and 6 month

  3. 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)

    Measured: Baseline and 12 month

  4. 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)

    Measured: Baseline and 3 month

  5. 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)

    Measured: Baseline and 6 month

  6. 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)

    Measured: Baseline and 12-month

Secondary outcomes (6)
  1. Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 3 months

    To asses an individuals attitudes towards alcohol services and treatment the Barriers to Help Seeking Scale (BSAT) measure will be used. The measure utilizes 53 total questions and consist of ten different domains (alcohol treatment, drinking goals, cultural background, immigration, drinking perceptions, feelings towards alcohol treatment services, friends and family, accessing services, life responsibilities, and treatment seeking). Each subscale is summed for a total subscale score (1 strongly agree to 5 strongly disagree). Change = (3month -baseline score)

    Measured: Baseline and 3-month

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

    To asses an individuals attitudes towards alcohol services and treatment the Barriers to Help Seeking Scale (BSAT) measure will be used. The measure utilizes 53 total questions and consist of ten different domains (alcohol treatment, drinking goals, cultural background, immigration, drinking perceptions, feelings towards alcohol treatment services, friends and family, accessing services, life responsibilities, and treatment seeking). Each subscale is summed for a total subscale score (1 strongly agree to 5 strongly disagree). Change = (6 month -baseline score)

    Measured: Baseline and 6-month

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

    To asses an individuals attitudes towards alcohol services and treatment the Barriers to Help Seeking Scale (BSAT) measure will be used. The measure utilizes 53 total questions and consist of ten different domains (alcohol treatment, drinking goals, cultural background, immigration, drinking perceptions, feelings towards alcohol treatment services, friends and family, accessing services, life responsibilities, and treatment seeking). Each subscale is summed for a total subscale score (1 strongly agree to 5 strongly disagree). Change = (12 month -baseline score)

    Measured: Baseline and 12-month

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

    Participants are first asked, "Have you ever gone anywhere or seen anyone for a reason that was related in any way to your drinking - a physician, counselor, Alcoholics Anonymous, or any other community agency or professional?" Participants who respond yes to this first item are told, "I am going to read you a list of community agencies and professionals. For each one, please tell me if you have ever gone for any reason related to your drinking." A list of thirteen types of treatment providers are listed. The 13 items will be summed to create a total score. Change = (3month -baseline score)

    Measured: Baseline and 3-month

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

    Participants are first asked, "Have you ever gone anywhere or seen anyone for a reason that was related in any way to your drinking - a physician, counselor, Alcoholics Anonymous, or any other community agency or professional?" Participants who respond yes to this first item are told, "I am going to read you a list of community agencies and professionals. For each one, please tell me if you have ever gone for any reason related to your drinking." A list of thirteen types of treatment providers are listed. The 13 items will be summed to create a total score. Change = (6 month -baseline score)

    Measured: Baseline and 6-month

  6. change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 12 months

    Participants are first asked, "Have you ever gone anywhere or seen anyone for a reason that was related in any way to your drinking - a physician, counselor, Alcoholics Anonymous, or any other community agency or professional?" Participants who respond yes to this first item are told, "I am going to read you a list of community agencies and professionals. For each one, please tell me if you have ever gone for any reason related to your drinking." A list of thirteen types of treatment providers are listed. The 13 items will be summed to create a total score. Change = (12 month -baseline score)

    Measured: Baseline and 12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start30 Jun 2023
  3. Primary completion1 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800899
Sponsor's protocol ID
UTexasElPaso
Status last verified
Aug 2025
First submitted
23 Feb 2023
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NIAAA Data Archive (NIAAADA) Per NOT-AA-22-003, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) expects investigators with applicable grant applications to include plans for sharing NIAAA-funded human subjects grant-related data with the NIAAA Data Archive (NIAAADA).

Questions about this trial

What is this clinical trial studying?

A study testing Brief Motivational Interviewing and Culturally adaptation brief motivational interviewing in people with Alcohol Use Disorder, run by University of Texas, El Paso at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Craig A Field, PhD ((915) 747-8539, cfield@utep.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 3-month (time frame: Baseline and 3 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in