- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429401
Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men (Project Valor)
Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men: a Randomized Clinical Trial Among Injured Patients
Study Overview
Status
Conditions
Detailed Description
Non-Adapted Brief Motivational Intervention: The core components of NA-BMI are consistent with the person-centered approach of MI and include 1) providing personalized feedback based on screening and baseline assessment results; 2) exploring decisional balance (pros and cons) of alcohol use from the patient's perspective; 3) building motivation for change through the assessment and discussion of the patients' selfreport of levels of importance, confidence, and readiness to change drinking; 4) enhancing commitment to change by exploring the patient's options for change and developing a change plan if indicated or desired; and 5) providing referrals for formal treatment of alcohol problems and other community resources. The NA-BMI will not specifically target cultural risk or protective factors beyond any normal tailoring that may occur in a standard BMI as described in the current literature. In NA-BMI, personalized feedback will be based on drinking norms and frequency of alcohol problems from the U.S. general population.
Culturally Adapted Brief Motivational Intervention: CA-BMI also adheres to the core principles of MI and practice of BMI. In CA-BMI, the core components of NA-BMI are adapted to be culturally responsive to the unique risk (acculturative stress) and protective (familism) factors associated with heavy drinking, alcohol problems, help seeking, and treatment utilization among Latinos. It is important to note that CA-BMI goes well beyond any tailoring that may occur in NA-BMI by targeting factors that are important predictors of drinking among Latinos. Specifically, there are two primary adaptations to the CA-BMI:
- CA-BMI will incorporate the assessment and personalized feedback on the impact of acculturative stress on drinking so as to decrease temptation to drink and increase confidence to avoid drinking. Specifically, participants will receive feedback about the types and intensity of acculturative stress they may experience (e.g., issues related to immigration, cultural congruity, language barriers, and employment discrimination), and clinicians will elicit the relationship of acculturative stress to temptation and confidence to avoid drinking.
- CA-BMI will also integrate family and community as reasons for change and as agents of behavior change when considering the impact of drinking, plans for changing drinking behavior, and engagement in help-seeking behaviors. Following methods developed by Lee et al. (2011) and Añez et al. (2008), consultants on the grant, investigators will incorporate a discussion of how social context and family dynamics are related to drinking.
These modifications result in a culturally adapted intervention that is substantially distinct in its content and focus (e.g., deep structural changes) from a non-adapted intervention, while maintaining consistency with motivational interviewing and its application in brief alcohol intervention. In accord with the two central adaptations, investigators anticipate that the potential mediators or mechanisms of behavior change specific to CA-BMI are 1) temptation to drink and confidence to avoid drinking and 2) increased support from family and friends in general as well as specific support to change drinking behavior and seek treatment. Finally, investigators will also evaluate a definition of treatment utilization that is more comprehensive than that in the investigators prior study, which assessed the use of formal inpatient and outpatient substance abuse treatment and attendance to self-help groups such as Alcoholics Anonymous (Field, et al., 2010). In the current study, investigators will assess engagement in formal treatment networks as well as informal help-seeking common among Latinos (e.g., seeking help from family, religious leaders, or respected elders in the community).
Statistical Analyses Preliminary Analyses: Standard examinations for outliers, data distribution, and internal consistency of measures will be conducted. For mixed models, investigators will assess the homogeneity of error and normality of residuals at all levels of the model, test for multivariate normality of random effects, examine linearity, and identify outliers. For structural equation models (SEM), investigators will follow the best practice guidelines outlined by Boomsma (2000) for analyzing and reporting SEM models. Investigators will also compare groups on all demographic and pretest variables to assess whether randomization produced equivalent groups; in the event of nonequivalent variables, these variables will be included as covariates in models.
Data Analysis for Specific Aim 1: Analyses investigating group differences in alcohol problems and treatment utilization will use random coefficient models (Raudenbush & Bryk, 2002; Singer & Willett, 2003). Investigators will construct longitudinal models using the following sequence of analytic steps recommended by Singer and Willett (2003): 1) examine empirical growth plots; 2) fit an unconditional means model; 3) fit an unconditional linear growth model; 4) fit an unconditional non-linear model (e.g., piecewise model); 5) determine the best model of longitudinal change by comparing models in the previous two steps using the Akaike information criterion (AIC); (f) select the most appropriate error covariance structure using AIC; and 6) add level-2 predictors (e.g., intervention conditions). Models for binary outcomes (e.g., treatment utilization) will use generalized linear mixed-effects models assuming a binary distribution with a logistic link function.
Data Analysis for Specific Aim 2: Potential moderators will be examined by constructing interaction terms between treatment and a priori moderator variables (e.g., acculturative stress) to examine the possibility that the relationship between a putative moderator and outcome differ across treatments (Aiken & West, 1991).
In the event of a significant interaction that indicates moderation, investigators will probe the relationship methods appropriate for multilevel models (Bauer & Curran, 2005).
Mediation analysis will be conducted using a growth-curve framework implemented in an SEM. Models will be constructed by first fitting growth models for mediators and outcomes and then fitting mediational growth models. Investigators will follow the same sequence described above for establishing the best model of longitudinal change for Aim 1. Latent growth models will be comprised of at least two latent factors; one factor will represent the initial status, and one or more factors will represent the growth rate of a variable, where more than one factor will be required in the event of non-linear change (e.g., a quadratic term). Mediation will be examined following recommendations by MacKinnon (2008) for assessing mediation in the growth models context. The growth factor of the mediator will be regressed on the initial status of the mediator, the outcome, and the intervention group. A significant effect for the intervention group establishes a relation between the intervention group and the mediator, controlling for baseline levels of the mediator and outcome. Next, the growth factor will be regressed on the initial status of the mediator, the outcome, the slope of the mediator, and the intervention group. A significant effect of the mediator growth factor establishes a relation between change in the mediator and change in the outcome, controlling for baseline levels of the mediators and outcome.
Data Analysis for Aim 3: Responses to patient and interventionist satisfaction and assessment of working alliance will be compiled in aggregate form. The frequency of responses to individual items will be reported for patients and interventionists. Likewise, scale scores for patients and providers will be reported using means and standard deviations. Comparison of responses of patients and interventionist will be made using chisquare in the case of frequency data and t-tests in the case of scale scores. Organizational readiness will be assessed using a pretest-posttest design. The analysis of pretest-posttest comparison will employ Analysis of Covariance or ANCOVA. In this nonrandomized design, the main purpose of ANCOVA is to adjust the posttest means for differences among groups on the pretest, because such differences are likely to occur. The purpose of using the pretest scores as a covariate in ANCOVA with a pretest-posttest design is to (a) reduce the error variance and (b) eliminate systematic bias.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Texas
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El Paso, Texas, United States, 79905
- Texas Tech University Health Sciences Center El Paso
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El Paso, Texas, United States, 79907
- University Medical Center of El Paso
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Culturally adapted brief intervention
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alcohol problems as measured by Short Index of Problems (SIP+6) questionnaire
Time Frame: 12 month
|
12 month
|
Alcohol use as measured by the Daily Drinking Questionnaire-Revised (DDQ-R)
Time Frame: 12 month
|
12 month
|
Treatment Utilization as measured by the treatment section of the Mexican American Prevalence and Services Study (MAPSS)
Time Frame: 12 month
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Therapeutic alliance rating as measured by Helping Alliance Questionnaire
Time Frame: 12 month
|
12 month
|
Social support as measured by Interpersonal Support Evaluation List-12 (ISEL-12)
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Craig A Field, PhD, University of Texas, El Paso
Publications and helpful links
General 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
- 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.
- Boomsma, A. (2000). Reporting analyses of covariance structures. Structural Equation Modeling, 7(3), 461-483. doi: 10.1207/S15328007SEM0703_6
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AD-1306-03852
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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