NCT02429401

Brief Summary

In this comparative-effectiveness study, investigators will recruit 400 English-speaking, Spanish-speaking, or bilingual heavy-drinking Mexican-origin men admitted to a community hospital for medical treatment of an alcohol-related injury or heavy drinking. Participants will be randomized to receive a culturally adapted brief motivational intervention (CA-BMI) or a non-adapted brief motivational intervention (NA-BMI). The primary outcomes of interest include alcohol use, alcohol problems, and treatment utilization. Secondary outcomes include therapeutic alliance ratings and social support. Telephone follow-up assessments will be completed at 3, 6, and 12 months post-treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

April 13, 2015

Last Update Submit

October 25, 2016

Conditions

Alcohol Consumption

Keywords

binge drinkingheavy drinking

Outcome Measures

Primary Outcomes (3)

  • Alcohol problems as measured by Short Index of Problems (SIP+6) questionnaire

    12 month

  • Alcohol use as measured by the Daily Drinking Questionnaire-Revised (DDQ-R)

    12 month

  • Treatment Utilization as measured by the treatment section of the Mexican American Prevalence and Services Study (MAPSS)

    12 month

Secondary Outcomes (2)

  • Therapeutic alliance rating as measured by Helping Alliance Questionnaire

    12 month

  • Social support as measured by Interpersonal Support Evaluation List-12 (ISEL-12)

    12 month

Study Arms (2)

Culturally adapted brief intervention

EXPERIMENTAL
Behavioral: Culturally adapted brief motivational interview

Non-adapted brief intervention

ACTIVE COMPARATOR
Behavioral: Non-adapted brief motivational interview

Interventions

Non-adapted brief motivational interviewBEHAVIORAL

1\) provide personalized feedback based on screening and baseline assessment, 2) explore decisional balance (pros and cons) of alcohol use from the patient's perspective, 3) build motivation for change through the assessment and discuss the patient's self-report of lf levels of importance, confidence, and readiness to change drinking, 4) enhance commitment to change by exploring the patient's options for change, and developing a change plan if indicated, 5) provide formal alcohol treatment referrals and community resources.

Non-adapted brief intervention
Culturally adapted brief motivational interviewBEHAVIORAL

Addresses impact of acculturative stress and drinking norms based on screening results and 1) provide personalized feedback based on screening and baseline assessment, 2) explore decisional balance (pros and cons) of alcohol use from the patient's perspective, 3) build motivation for change through the assessment and discuss the patient's self-report of lf levels of importance, confidence, and readiness to change drinking, 4) enhance commitment to change by exploring the patient's options for change, and developing a change plan if indicated, 5) provide formal alcohol treatment referrals and community resources.

Culturally adapted brief intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Injury currently being treated at University Medical Center
  • Drinking: weekly average of 15 drinks or more or 5 drinks or more on any day in past year
  • Hispanic, Latino, Mexican, or Mexican American
  • Speaks Spanish, English or both

You may not qualify if:

  • Non-injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

University Medical Center of El Paso

El Paso, Texas, 79907, United States

Location

Related Publications (10)

  • Singer, J., & Willet, J. (2003). Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press.

    BACKGROUND

  • Aiken, L. S., & West, S. G. (1991). Multiple regression: Testing and interpreting interactions. Thousand Oaks, CA: SAGE.

    BACKGROUND

  • Anez, L. M., Silva, M. A., Paris, M., Jr., & Bedregal, L. E. (2008). Engaging Latinos through the integration of cultural values and motivational interviewing principles. Professional Psychology: Research and Practice, 39(2), 153-159. doi: 10.1037/0735-7028.39.2.153

    BACKGROUND

  • Bauer DJ, Curran PJ. Probing Interactions in Fixed and Multilevel Regression: Inferential and Graphical Techniques. Multivariate Behav Res. 2005;40(3):373-400. doi: 10.1207/s15327906mbr4003_5.

    PMID: 26794689BACKGROUND

  • Boomsma, A. (2000). Reporting analyses of covariance structures. Structural Equation Modeling, 7(3), 461-483. doi: 10.1207/S15328007SEM0703_6

    BACKGROUND

  • Field CA, Caetano R, Harris TR, Frankowski R, Roudsari B. Ethnic differences in drinking outcomes following a brief alcohol intervention in the trauma care setting. Addiction. 2010 Jan;105(1):62-73. doi: 10.1111/j.1360-0443.2009.02737.x. Epub 2009 Nov 17.

    PMID: 19919597BACKGROUND

  • Lee CS, Lopez SR, Hernandez L, Colby SM, Caetano R, Borrelli B, Rohsenow D. A cultural adaptation of motivational interviewing to address heavy drinking among Hispanics. Cultur Divers Ethnic Minor Psychol. 2011 Jul;17(3):317-24. doi: 10.1037/a0024035.

    PMID: 21787064BACKGROUND

  • MacKinnon, D. (2008). Multivariate Applications: Introduction to Statistical Mediation Analysis. New York: Lawrence Erlbaum Associates.

    BACKGROUND

  • Raudenbush, S., & Bryk, A. (2002). Hierarchical linear models Applications and data analysis methods Volume 1. Advanced quantitative techniques in the social sciences Volume 2. Thousand Oaks, CA: SAGE.

    BACKGROUND

  • Field CA, Cabriales JA, Woolard RH, Tyroch AH, Caetano R, Castro Y. Cultural adaptation of a brief motivational intervention for heavy drinking among Hispanics in a medical setting. BMC Public Health. 2015 Jul 30;15:724. doi: 10.1186/s12889-015-1984-y.

    PMID: 26223781DERIVED

MeSH Terms

Conditions

Alcohol DrinkingBinge Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Craig A Field, PhD

    University of Texas, El Paso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 29, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(2)