A Randomized Clinical Trial of Culturally Tailored MI (CTMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Northeastern University
Sponsor:
Information provided by (Responsible Party):
Northeastern University
ClinicalTrials.gov Identifier:
NCT01996280
First received: June 17, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Alcohol Drinking
Behavioral: Motivational Interviewing
Behavioral: Culturally Tailored MI
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Culturally Tailored Motivational Interviewing

Resource links provided by NLM:


Further study details as provided by Northeastern University:

Primary Outcome Measures:
  • Change in Frequency of Heavy Drinking Days [ Time Frame: Baseline, 3-, 6-, and 12-month follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Frequency of Alcohol-Related Negative Consequences [ Time Frame: Baseline, 3-, 6-. 12-month follow up ] [ Designated as safety issue: No ]
    Frequency of alcohol-related consequences will be assessed using the Drinker Inventory of Consequences (DrInC) and its' five subscales, as well as the Drinking and Driving Scale. The DrInC will be administered at baseline, 3-, 6-, and 12-month follow up whereas the Drinking and Driving scale will be administered at baseline and again at the 12-month follow up session. Changes in the frequency of reported negative alcohol-related consequences will be examined across these time points.


Estimated Enrollment: 250
Study Start Date: December 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Motivational Interviewing
The 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.
Behavioral: Motivational Interviewing
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.
Experimental: Culturally Tailored MI
The 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.
Behavioral: Culturally Tailored MI
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 18-65 years old
  • Able to speak English or Spanish

Exclusion Criteria:

  • 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

    1. Is the study voluntary
    2. Can he/she drop out at any time
    3. Will there be study follow-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996280

Contacts
Contact: Christina S Lee, Ph.D 617-373-2470 Chr.lee@neu.edu
Contact: Tonya L Tavares, MS 617-373-6891 t.tavares@neu.edu

Locations
United States, Massachusetts
Northeastern University Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Christina S Lee, Ph.D         
South End Community Health Center Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Christina S Lee, Ph.D         
Sponsors and Collaborators
Northeastern University
Investigators
Principal Investigator: Christina S Lee, Ph.D Northeastern University
  More Information

No publications provided

Responsible Party: Northeastern University
ClinicalTrials.gov Identifier: NCT01996280     History of Changes
Other Study ID Numbers: PA-10-100
Study First Received: June 17, 2013
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on October 19, 2014