RECRUITING

A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Addressing Alcohol-Use Related Health Disparities: A Hybrid Effectiveness Implementation Study of a Culturally Adapted MI for Latino/a Alcohol and Drug Users

Quick Facts

Study Start:2022-03-25
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04771650

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets criteria for binge drinking in the past month (\> 4/5 (females/males) drinks/occasion, 1+ days/month)
  2. * Age 18 or older
  3. * Identify as Latinx
  4. * First or second-generation immigrant
  1. * Current psychotic symptoms
  2. * Cognitive impairment
  3. * Currently in psychosocial treatment for alcohol use disorder
  4. * Patients who have been enrolled in the Complex Care Management (CCM) before January 1, 2021.

Contacts and Locations

Study Contact

Christina S Lee, PhD
CONTACT
617 353 1415
leecs@bu.edu

Principal Investigator

Christina S Lee, PhD
PRINCIPAL_INVESTIGATOR
Boston University

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02215
United States
Mercy Medical Center
Springfield, Massachusetts, 01104
United States

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

  • Christina S Lee, PhD, PRINCIPAL_INVESTIGATOR, Boston University

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 Registration Dates

Study Start Date2022-03-25
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2022-03-25
Study Completion Date2028-08-01

Terms related to this study

Keywords Provided by Researchers

  • Alcohol
  • Drug
  • Latinx
  • Treatment
  • Psychological distress

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Drug Use
  • Psychological Distress