- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04771650
A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users (CAMI-HI)
September 22, 2023 updated by: Christina Lee, Boston University Charles River Campus
Addressing Alcohol-Use Related Health Disparities: A Hybrid Effectiveness Implementation Study of a Culturally Adapted MI for Latino/a Alcohol and Drug Users
Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use.
A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science.
This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting.
The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol?
How do providers view this intervention?
The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers.
The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention.
Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs.
assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach.
The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes.
This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use.
Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Alcohol use is a significant problem among Latinxs because of the disproportionate burden of physical harms and negative consequences associated with substance use relative to other racial/ethnic groups.
Factors associated with the stress related to being an immigrant increase risk for substance use.
A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of stressors related to immigration (e.g., discrimination, stigma, social isolation) resulted in significant reductions in harms related to alcohol for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious interventions for addictions are not common, yet are needed to advance implementation science because they address questions that are the basis for successful implementation.
The proposed Hybrid Type 1 Effectiveness-Implementation study is an important next step in this line of research, which is to investigate the feasibility of implementing the CAMI intervention in a real-world clinical setting.
The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol?
How do providers view this intervention?
The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver the CAMI to patients who are heavy drinkers.
The investigators will conduct a concurrent investigation on the process of implementing the CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention.
Specific Aims are: (1) To examine the impact of CAMI plus an in- person booster session (vs.
assessment only) on outcomes: % heavy drinking days, frequency of alcohol- related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach.
The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes: acceptability, adoption, intervention appropriateness, feasibility, overall cost (i.e., CAMI vs. assessment only), and treatment fidelity.
This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use.
Long term goals are to translate the lessons from the proposed Hybrid study to the broader community to focus on population health for all primary care patients.
Study Type
Interventional
Enrollment (Estimated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina S Lee, PhD
- Phone Number: 617 353 1415
- Email: leecs@bu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Boston Medical Center
-
Contact:
- Christine Pace, MD
- Email: CHRISTINE.PACE@BMC.ORG
-
Springfield, Massachusetts, United States, 01104
- Recruiting
- Mercy Medical Center
-
Contact:
- Ari Kriegsman, MD
- Email: Ari.Kriegsman@trinityhealthofne.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Meets criteria for binge drinking in the past month (> 4/5 (females/males) drinks/occasion, 1+ days/month)
- Age 18 or older
- Identify as Latinx
- First or second-generation immigrant
Exclusion Criteria:
- Current psychotic symptoms
- Cognitive impairment
- Currently in psychosocial treatment for alcohol use disorder
- Patients who have been enrolled in the Complex Care Management (CCM) before January 1, 2021.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: CAMI/CAMI booster
Culturally Adapted Motivational Interview.
Participants will receive a single session, 75 minute addiction counseling discussion that focuses on the causes of addictive behavior.
They will receive a CAMI booster session at 2 months and standard care in a primary care setting.
|
The CAMI is a culturally adapted motivational interview.
It is a single 75 minute session that focuses on promoting motivation to change drinking and drug use behavior.
|
No Intervention: Control
Assessment plus standard care.
Participants will complete an assessment, including measures on drinking and drug use.
They will also receive standard care in a primary care setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent heavy drinking days
Time Frame: 3 month follow-up
|
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
|
3 month follow-up
|
Alcohol-related consequences
Time Frame: 3 month follow-up
|
Frequency of alcohol related consequences (e.g., driving under the influence).
|
3 month follow-up
|
Percent drug use days
Time Frame: 3 month follow-up
|
% drug use days
|
3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent heavy drinking days
Time Frame: 6 month follow-up
|
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
|
6 month follow-up
|
Percent heavy drinking days
Time Frame: 12 month follow-up
|
% heavy drinking days (4 or 5 drinks/day female/male, respectively)
|
12 month follow-up
|
Alcohol-related consequences
Time Frame: 6 month follow-up
|
Frequency of alcohol related consequences (e.g., driving under the influence).
|
6 month follow-up
|
Alcohol-related consequences
Time Frame: 12 month follow-up
|
Frequency of alcohol related consequences (e.g., driving under the influence).
|
12 month follow-up
|
Center for Epidemiological Studies - Depression
Time Frame: 3 month follow-up
|
Level of depressive symptomatology in the past week.
|
3 month follow-up
|
Center for Epidemiological Studies - Depression
Time Frame: 6 month follow-up
|
Level of depressive symptomatology in the past week.
|
6 month follow-up
|
Center for Epidemiological Studies - Depression
Time Frame: 12 month follow-up
|
Level of depressive symptomatology in the past week.
|
12 month follow-up
|
Beck Anxiety Inventory
Time Frame: 3 month follow-up
|
Level of anxiety symptomatology in the past week.
|
3 month follow-up
|
Beck Anxiety Inventory
Time Frame: 6 month follow-up
|
Level of anxiety symptomatology in the past week.
|
6 month follow-up
|
Beck Anxiety Inventory
Time Frame: 12 month follow-up
|
Level of anxiety symptomatology in the past week.
|
12 month follow-up
|
Percent drug use days
Time Frame: 6 month follow-up
|
% drug use days
|
6 month follow-up
|
Percent drug use days
Time Frame: 12 month follow-up
|
% drug use days
|
12 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christina S Lee, PhD, Boston University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lee CS, Colby SM, Magill M, Almeida J, Tavares T, Rohsenow DJ. A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of adaptation and study protocol. Contemp Clin Trials. 2016 Sep;50:193-200. doi: 10.1016/j.cct.2016.08.013. Epub 2016 Aug 24.
- Lee 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2022
Primary Completion (Estimated)
April 25, 2027
Study Completion (Estimated)
August 1, 2028
Study Registration Dates
First Submitted
February 11, 2021
First Submitted That Met QC Criteria
February 24, 2021
First Posted (Actual)
February 25, 2021
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5688
- 1R01AA028507 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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