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International Latino Research Partnership (ILRP)

Primary Purpose

Substance Use (Drugs, Alcohol)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Integrated Intervention for Dual Problems and Early Action
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use (Drugs, Alcohol) focused on measuring Dual-diagnosis, Latino, Mental health, Substance use, HIV risk

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cambridge Health Alliance
  • Vall d'Hebron University Hospital
  • Universidad Autonoma de Madrid Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

IIDEA

Usual Care

Arm Description

Patients in the Integrated Intervention for Dual Problems and Early Action (IIDEA) arm will receive the 10 session intervention administered in person and via telephone.

Patients in this arm receive usual care for dual-diagnosis symptoms of mental health and substance use. They receive 5 check-in calls from a care manager to assess safety.

Outcomes

Primary Outcome Measures

Addiction Severity Index (ASI) - Alcohol (change)
The ASI is a semi-structured interview designed to address seven potential problem areas in substance-abusing patients; this outcome measure refers to the Alcohol problem area.
Addiction Severity Index (ASI) - Drugs (change)
The ASI is a semi-structured interview designed to address seven potential problem areas in substance-abusing patients; this outcome measure refers to the Drug problem area.
Change on Urine Drug Test (change)
Technical analysis of a biological specimen (urine) to determine the presence or absence of specified parent drugs or their metabolites.

Secondary Outcome Measures

Generalized Anxiety Disorder 7-item (GAD-7) Scale (change)
The GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
PTSD Checklist for DSM-V (PCL-5)
The PCL-5 is is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Patient Health Questionnaire (PHQ-9) (change)
The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder.
Hopkins Symptom Checklist-20
The HSCL-20 is a symptom inventory for depression that indicates severity of psychological distress.

Full Information

First Posted
January 14, 2014
Last Updated
April 27, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Hospital Vall d'Hebron, Universidad Autonoma de Madrid, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02038855
Brief Title
International Latino Research Partnership
Acronym
ILRP
Official Title
International Latino Research Partnership
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Hospital Vall d'Hebron, Universidad Autonoma de Madrid, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use (Drugs, Alcohol)
Keywords
Dual-diagnosis, Latino, Mental health, Substance use, HIV risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IIDEA
Arm Type
Active Comparator
Arm Description
Patients in the Integrated Intervention for Dual Problems and Early Action (IIDEA) arm will receive the 10 session intervention administered in person and via telephone.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in this arm receive usual care for dual-diagnosis symptoms of mental health and substance use. They receive 5 check-in calls from a care manager to assess safety.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Intervention for Dual Problems and Early Action
Intervention Description
Integrated Intervention for Dual Problems and Early Action (IIDEA) includes psycho-education, Cognitive Behavioral Therapy and mindfulness; identifies triggers and challenging thoughts; provides motivational techniques for reducing substance use and/or smoking cravings; incorporates cognitive restructuring to identify and correct negative thinking patterns influenced by depression, anxiety and/or trauma; and includes self-monitoring of thoughts and risk behaviors that contribute to substance use, smoking and increased HIV risk.
Primary Outcome Measure Information:
Title
Addiction Severity Index (ASI) - Alcohol (change)
Description
The ASI is a semi-structured interview designed to address seven potential problem areas in substance-abusing patients; this outcome measure refers to the Alcohol problem area.
Time Frame
Baseline, 2 months, 4 months, 6 months, 12 months
Title
Addiction Severity Index (ASI) - Drugs (change)
Description
The ASI is a semi-structured interview designed to address seven potential problem areas in substance-abusing patients; this outcome measure refers to the Drug problem area.
Time Frame
Baseline, 2 months, 4 months, 6 months, 12 months
Title
Change on Urine Drug Test (change)
Description
Technical analysis of a biological specimen (urine) to determine the presence or absence of specified parent drugs or their metabolites.
Time Frame
Baseline, 2 months, 4 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder 7-item (GAD-7) Scale (change)
Description
The GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
Time Frame
Baseline, 2 months, 4 months, 6 months, 12 months
Title
PTSD Checklist for DSM-V (PCL-5)
Description
The PCL-5 is is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Time Frame
Baseline, 2 months, 4 months, 6 months, 12 months
Title
Patient Health Questionnaire (PHQ-9) (change)
Description
The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder.
Time Frame
Baseline, 2 months, 4 months, 6 months, 12 months
Title
Hopkins Symptom Checklist-20
Description
The HSCL-20 is a symptom inventory for depression that indicates severity of psychological distress.
Time Frame
Baseline, 2 months, 4 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Alegria, Ph.D.
Organizational Affiliation
CMMHR, Cambridge Health Alliance and Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrique Baca-Garcia, Ph.D.
Organizational Affiliation
Universidad Autonoma de Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Collazos, MD
Organizational Affiliation
Vall d'Hebron University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Health Alliance
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02143
Country
United States
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
State/Province
Catalonia
Country
Spain
Facility Name
Universidad Autonoma de Madrid Medical School
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30737609
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.
Results Reference
derived
PubMed Identifier
30646205
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.
Results Reference
derived
Links:
URL
http://www.multiculturalmentalhealth.org/International_Latino_Research_Partnership.asp
Description
Project Website

Learn more about this trial

International Latino Research Partnership

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