Clinical trial NCT02038855: International Latino Research Partnership
Official title: International Latino Research Partnership
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use (Drugs, Alcohol)
Keywords: Dual-diagnosis
Latino
Mental health
Substance use
HIV risk
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Universidad Autonoma de Madrid
name: National Institute on Drug Abuse (NIDA)
First posted: 2014-01-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and intervention project designed to improve the quality of care for Latino patients with comorbid mental health and substance use problems. We will first test a screening of comorbid problems with patients identified in mental health as well as primary health care. Building on that work, we will test the feasibility, acceptability and efficacy of the "Integrated Intervention for Dual Problems and Early Action" (IIDEA) intervention addressing mental health, substance use, and prevention of HIV, as well as a smoking cessation supplement. The project is being conducted in Massachusetts as well as at two sites in Spain. As such, the proposed ILRP multi-site international project is a critical step towards developing models of integrated care for the large and diverse Latino migrant population and more broadly towards understanding how best to integrate evidence-based assessment and treatments for co-occurring substance and mental health problems and HIV risks.

Detailed description: Our study aims to conduct behavioral health services research focused on rapid screening and referral; as well as testing the feasibility, acceptability and efficacy of integrated behavioral health services in primary care clinics for migrant Latinos with co-occurring substance use and mental health problems, and increased risk of HIV.

A key activity for the first phase, the screening project, is administering a screener to at least 450 Latino migrant patients across the 3 sites (n=150 each in Boston, Madrid, and Barcelona) from primary care and behavioral health (substance abuse and mental health) services. We intend to test the referral process for screened participants in need of treatment to identify barriers and streamline the process. We will analyze data to optimize the screening battery and protocol to use in Phase 2, the IIDEA intervention.

In Phase 2, we intend to enroll, randomize and collect data on 360 total patients across the 3 sites - 180 in the intervention condition and 180 in the control condition (120 in each site, 60 in the intervention condition and 60 in the control condition). The 10 session IIDEA intervention will be offered to Latino patients by trained clinicians with at least a Masters level of training. The intervention is designed to help patients to address and prevent mental health and substance use problems and will be culturally adapted to Latino populations in Boston, Madrid and Barcelona. Usual care - the control group - receives treatment as usual, for patients in primary care identified with a mental health or substance use problem. 5 Research interviews will be conducted to assess outcomes, for patients in both the intervention and usual care arms.

Eligibility criteria: Inclusion Criteria:

* Latino migrants
* Must speak English or Spanish
* 18-70 years of age
* Screen positive to at least one substance use and one mental health problem

Exclusion Criteria:

* Current or recent (last 3 months) substance use treatment (more than 1 visit with a provider at a behavioral health clinic)
* Planning to receive behavioral health services (i.e., have an appointment scheduled in the next 2 months)
* Evidence that the patient lacks capacity to consent to the study
* Evidence of current suicidal risk or harm to others (affirmative responses to questions 4 and/or 5 on Paykel suicide questionnaire)- patient can be rescreened in 30 days

Primary outcomes:
measure: Addiction Severity Index (ASI) - Alcohol (change)
timeFrame: Baseline, 2 months, 4 months, 6 months, 12 months
measure: Addiction Severity Index (ASI) - Drugs (change)
timeFrame: Baseline, 2 months, 4 months, 6 months, 12 months
measure: Change on Urine Drug Test (change)
timeFrame: Baseline, 2 months, 4 months, 6 months, 12 months
Secondary outcomes:
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale (change)
timeFrame: Baseline, 2 months, 4 months, 6 months, 12 months
measure: PTSD Checklist for DSM-V (PCL-5)
timeFrame: Baseline, 2 months, 4 months, 6 months, 12 months
measure: Patient Health Questionnaire (PHQ-9) (change)
timeFrame: Baseline, 2 months, 4 months, 6 months, 12 months
measure: Hopkins Symptom Checklist-20
timeFrame: Baseline, 2 months, 4 months, 6 months, 12 months
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
state: Catalonia
city: Madrid
country: Spain
facility: Universidad Autonoma de Madrid Medical School
Study officials:
affiliation: CMMHR, Cambridge Health Alliance and Harvard Medical School
name: Margarita Alegria, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma de Madrid
name: Enrique Baca-Garcia, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vall d'Hebron University Hospital
name: Francisco Collazos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levison JH, Alegria M, Wang Y, Markle SL, Fuentes L, Mejia DL, Tarbox A, Albarracin Garcia L, Cellerino L, El-Bassel N. High HIV/STI Test Acceptance Through a Behavioral Health Encounter in Latino Immigrants with Substance Use and Mental Health Problems. AIDS Behav. 2019 Apr;23(4):835-846. doi: 10.1007/s10461-019-02413-y.
citation: Alegria M, Falgas-Bague I, Collazos F, Carmona Camacho R, Lapatin Markle S, Wang Y, Baca-Garcia E, Le Cook B, Chavez LM, Fortuna L, Herrera L, Qureshi A, Ramos Z, Gonzalez C, Aroca P, Albarracin Garcia L, Cellerino L, Villar A, Ali N, Mueser KT, Shrout PE. Evaluation of the Integrated Intervention for Dual Problems and Early Action Among Latino Immigrants With Co-occurring Mental Health and Substance Misuse Symptoms: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186927. doi: 10.1001/jamanetworkopen.2018.6927.