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Trial record 1 of 1 for:    NCT02429401
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Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men (Project Valor)

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ClinicalTrials.gov Identifier: NCT02429401
Recruitment Status : Terminated (Study terminated due to low recruitment (funding agency halted study).)
First Posted : April 29, 2015
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Texas, El Paso

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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Behavioral: Non-adapted brief motivational interview Behavioral: Culturally adapted brief motivational interview Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men: a Randomized Clinical Trial Among Injured Patients
Study Start Date : August 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Culturally adapted brief intervention Behavioral: Culturally adapted brief motivational interview
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.

Active Comparator: Non-adapted brief intervention Behavioral: Non-adapted brief motivational interview
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.




Primary Outcome Measures :
  1. Alcohol problems as measured by Short Index of Problems (SIP+6) questionnaire [ Time Frame: 12 month ]
  2. Alcohol use as measured by the Daily Drinking Questionnaire-Revised (DDQ-R) [ Time Frame: 12 month ]
  3. Treatment Utilization as measured by the treatment section of the Mexican American Prevalence and Services Study (MAPSS) [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Therapeutic alliance rating as measured by Helping Alliance Questionnaire [ Time Frame: 12 month ]
  2. Social support as measured by Interpersonal Support Evaluation List-12 (ISEL-12) [ Time Frame: 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429401


Locations
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United States, Texas
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States, 79905
University Medical Center of El Paso
El Paso, Texas, United States, 79907
Sponsors and Collaborators
University of Texas, El Paso
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Craig A Field, PhD University of Texas, El Paso
Publications:
Singer, J., & Willet, J. (2003). Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press.
Aiken, L. S., & West, S. G. (1991). Multiple regression: Testing and interpreting interactions. Thousand Oaks, CA: SAGE.
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
Boomsma, A. (2000). Reporting analyses of covariance structures. Structural Equation Modeling, 7(3), 461-483. doi: 10.1207/S15328007SEM0703_6
MacKinnon, D. (2008). Multivariate Applications: Introduction to Statistical Mediation Analysis. New York: Lawrence Erlbaum Associates.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Texas, El Paso
ClinicalTrials.gov Identifier: NCT02429401    
Other Study ID Numbers: AD-1306-03852
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by University of Texas, El Paso:
binge drinking
heavy drinking
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior