Alcohol ConsumptionProject ValorNCT02429401
Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men
A study testing Non-adapted brief motivational interview and Culturally adapted brief motivational interview in people with Alcohol Consumption, run by University of Texas, El Paso at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Non-adapted brief motivational interview and Culturally adapted brief motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-injury
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905
University Medical Center of El Paso
El Paso, Texas, 79907
About this study
Official title: Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men: a Randomized Clinical Trial Among Injured Patients
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.
Read the 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.
- Conditions
- Alcohol Consumption
- Being tested
- Non-adapted brief motivational interview, Culturally adapted brief motivational interview
- Keywords
- binge drinking, heavy drinking
- Medical subject headings
- Alcohol Drinking, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-adapted brief motivational interviewBehavioural
- 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 motivational interviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted brief intervention | Experimental | Not described Receives: Behavioral: Culturally adapted brief motivational interview |
| Non-adapted brief intervention | Active comparator | Not described Receives: Behavioral: Non-adapted brief motivational interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol problems as measured by Short Index of Problems (SIP+6) questionnaire
Measured: 12 month
Alcohol use as measured by the Daily Drinking Questionnaire-Revised (DDQ-R)
Measured: 12 month
Treatment Utilization as measured by the treatment section of the Mexican American Prevalence and Services Study (MAPSS)
Measured: 12 month
Secondary outcomes (2)
Therapeutic alliance rating as measured by Helping Alliance Questionnaire
Measured: 12 month
Social support as measured by Interpersonal Support Evaluation List-12 (ISEL-12)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Study terminated due to low recruitment (funding agency halted study).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas, El Paso
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Craig A Field, PhD, Principal investigator, University of Texas, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429401
- Sponsor's protocol ID
- AD-1306-03852
- Acronym
- Project Valor
- Status last verified
- Oct 2016
- First submitted
- 13 Apr 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26794689Boomsma, 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.
PubMed 19919597Lee 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.
PubMed 21787064MacKinnon, 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.
PubMed 26223781
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men: a Randomized Clinical Trial Among Injured Patients
- ClinicalTrials.gov ID
- NCT02429401
- Acronym / sponsor ID
- Project Valor / AD-1306-03852
- Conditions
- Alcohol Consumption
- Keywords
- binge drinking, heavy drinking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low recruitment (funding agency halted study).
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Texas, El PasoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted brief intervention | Experimental | Behavioral: Culturally adapted brief motivational interview |
| Non-adapted brief intervention | Active comparator | Behavioral: Non-adapted brief motivational interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Non-injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-adapted brief motivational interview1) 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. | Behavioural | Non-adapted brief intervention |
| Culturally adapted brief motivational interviewAddresses 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. | Behavioural | Culturally adapted brief intervention |
Primary outcome
Alcohol problems as measured by Short Index of Problems (SIP+6) questionnaire
Time frame: 12 month
Alcohol use as measured by the Daily Drinking Questionnaire-Revised (DDQ-R)
Time frame: 12 month
Treatment Utilization as measured by the treatment section of the Mexican American Prevalence and Services Study (MAPSS)
Time frame: 12 month
2 secondary outcomes
Therapeutic alliance rating as measured by Helping Alliance Questionnaire
Time frame: 12 month
Social support as measured by Interpersonal Support Evaluation List-12 (ISEL-12)
Time frame: 12 month
Results and safety
The study was stopped early (reason given: Study terminated due to low recruitment (funding agency halted study).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- BackgroundSinger, J., & Willet, J. (2003). Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press.
- BackgroundAiken, L. S., & West, S. G. (1991). Multiple regression: Testing and interpreting interactions. Thousand Oaks, CA: SAGE.
- BackgroundAnez, 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: PubMed 26794689Bauer 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.
- BackgroundBoomsma, A. (2000). Reporting analyses of covariance structures. Structural Equation Modeling, 7(3), 461-483. doi: 10.1207/S15328007SEM0703_6
- Background: PubMed 19919597Field 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.
- Background: PubMed 21787064Lee 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.
- BackgroundMacKinnon, D. (2008). Multivariate Applications: Introduction to Statistical Mediation Analysis. New York: Lawrence Erlbaum Associates.
- BackgroundRaudenbush, 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.
- Derived from this study: PubMed 26223781Field 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig A Field, PhD principal investigator
University of Texas, El Paso
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-adapted brief motivational interview and Culturally adapted brief motivational interview in people with Alcohol Consumption, run by University of Texas, El Paso at 2 sites 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Study terminated due to low recruitment (funding agency halted study).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol problems as measured by Short Index of Problems (SIP+6) questionnaire (time frame: 12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429401, which also lists 10 linked publications.
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 27 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.