A Randomized Clinical Trial of Culturally Tailored MI
CTMI
1 other identifier
interventional
301
1 country
2
Brief Summary
Culturally-tailored empirically-based interventions are needed because Latinos suffer a greater burden of alcohol-related health disparities and negative social consequences compared to other racial/ethnic groups, are less likely to initiate and to remain in treatment, and are more likely to live in communities with a high density of alcohol outlets. Pilot data from the PI's (New Investigator) K award (AA014905), which will serve as the basis for the current proposed larger-scale study, demonstrated that culturally tailored motivational interviewing (CTMI) outperformed motivational interviewing (MI) that was not tailored to the needs of Latino heavy drinkers. The public health impact of this study will be to develop a program of early screening and brief intervention to reduce hazardous drinking among Latinos, to minimize the burden of illness and social consequences that disproportionately affect Latino communities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedStudy Start
First participant enrolled
August 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedApril 1, 2019
March 1, 2019
3.2 years
June 17, 2013
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Frequency of Heavy Drinking Days
The frequency of heavy drinking days will be assessed using a 90 day Timeline Follow Back (TLFB) collected at baseline prior to study intervention. TLFB will be administered again at the 3-, 6-, and 12-month follow up periods. Changes in frequency of heavy drinking days will be assessed across all study time points.
Baseline, 3-, 6-, and 12-month follow-up
Secondary Outcomes (1)
Change in Frequency of Alcohol-Related Negative Consequences
Baseline, 3-, 6-. 12-month follow up
Study Arms (2)
Motivational Interviewing
PLACEBO COMPARATORThe MI is a single brief motivational intervention lasting 1.5 hours that includes MI structured strategies tailored to the patient's readiness to change such as: the Typical Day exercise, the use of personal feedback reports (e.g., normative feedback about their drinking), discussions about the pros and cons of use, and completion of a change plan. The MI is designed to follow MI principles of invoking autonomy and emphasizing collaboration with the interventionist.
Culturally Tailored MI
EXPERIMENTALThe CTMI is a single brief motivational interview lasting 1.5 hours. It follows the same sequence of structured strategies as the MI, but the focus of the components is different. CTMI has augmented some of the components with culturally relevant material, including discussion about acculturation stress. The CTMI components are culturally tailored to address relevant concerns and issues. There are also culturally tailored feedback elements in the CTMI, such as ethnic normative feedback about drinking. To control for time across conditions, interventionists are instructed to select CTMI components based on participant interests, not the entire array of components.
Interventions
The MI is a single brief motivational intervention lasting 1.5 hrs. The MI includes MI structured strategies tailored to the patient's readiness to change such as: the Typical Day exercise, the use of personal feedback reports (e.g., normative feedback about their drinking), discussions about the pros and cons of use, and completion of a change plan; It is designed to follow MI principles of invoking autonomy and emphasizing collaboration with the interventionist.
CTMI is a single brief motivational intervention lasting 1.5hrs. The CTMI follows the same sequence of structured strategies as the MI arm, and while the components in CTMI and MI are parallel, the focus within them is different. CTMI components culturally relevant material, such as acculturation stress. The CTMI components, which are MI structured strategies, are culturally tailored to address relevant concerns and issues. There are also culturally tailored feedback element, such as ethnic normative feedback related to drinking.
Eligibility Criteria
You may qualify if:
- Meet criteria for hazardous drinking (greater than or equal to 5/4 per occasion for males/females), two or more times in the past 30 days.
- Latino
- Are not currently in any substance use treatment program for alcohol use disorder, nor have been in the past year.
- years old
- Able to speak English or Spanish
You may not qualify if:
- Psychotic symptoms, as evidenced by hallucinations or delusions.
- Cognitive impairment, as evidenced by inability to understand informed consent. a. To determine comprehension, a research assistant will read informed consent aloud and will ask 3 questions
- Is the study voluntary
- Can he/she drop out at any time
- Will there be study follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northeastern University
Boston, Massachusetts, 02115, United States
South End Community Health Center
Boston, Massachusetts, 02118, United States
Related Publications (4)
Rosales R, Lee CS, Cortes D, Caetano R, Rohsenow DJ, Lopez SR, Colby SM. Development and Evaluation of a Measure of Drinking Behavior in Response to Acculturation Stressors for Latinx Adults Entering Alcohol Treatment. J Subst Use Addict Treat. 2023 Dec;155:208936. doi: 10.1016/j.josat.2022.208936. Epub 2023 Jan 13.
PMID: 38434594DERIVEDHai AH, Lee CS, Zhou C, Delva J. Culturally adapted motivational interviewing's effects on drinking in response to immigration and acculturation stressors among Latinx adults with heavy drinking problems. J Subst Use Addict Treat. 2023 Jul;150:209061. doi: 10.1016/j.josat.2023.209061. Epub 2023 May 6.
PMID: 37156426DERIVEDLee CS, Colby SM, Rohsenow DJ, Martin R, Rosales R, McCallum TT, Falcon L, Almeida J, Cortes DE. A randomized controlled trial of motivational interviewing tailored for heavy drinking latinxs. J Consult Clin Psychol. 2019 Sep;87(9):815-830. doi: 10.1037/ccp0000428.
PMID: 31403817DERIVEDLee CS, Almeida J, Colby SM, Tavares T, Rohsenow DJ. Acculturation, hazardous drinking and depressive symptomatology among Hispanics enrolled in a clinical trial. Addict Res Theory. 2016 Jan 1;24(1):69-79. doi: 10.3109/16066359.2015.1072517. Epub 2015 Jul 28.
PMID: 26819573DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina S Lee, Ph.D
Northeastern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
November 27, 2013
Study Start
August 26, 2014
Primary Completion
October 30, 2017
Study Completion
November 30, 2017
Last Updated
April 1, 2019
Record last verified: 2019-03