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International Latino Research Partnership (ILRP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Cambridge Health Alliance
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Universidad Autonoma de Madrid
Information provided by (Responsible Party):
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT02038855
First received: January 14, 2014
Last updated: January 15, 2014
Last verified: January 2014

January 14, 2014
January 15, 2014
April 2014
August 2016   (final data collection date for primary outcome measure)
  • Addiction Severity Index (ASI) - Alcohol (change) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    Technical analysis of a biological specimen (urine) to determine the presence or absence of specified parent drugs or their metabolites.
Same as current
Complete list of historical versions of study NCT02038855 on ClinicalTrials.gov Archive Site
  • Generalized Anxiety Disorder 7-item (GAD-7) Scale (change) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    he GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
  • Posttraumatic Cognitions Inventory (PTCI) (change) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    The PTCI is a measure of trauma-related thoughts and beliefs whose items were derived from clinical observations and current theories of post-trauma psychopathology.
  • Patient Health Questionnaire (PHQ-9) (change) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder.
  • Fagerström Test for Nicotine Dependence (change) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine.
Same as current
Not Provided
Not Provided
 
International Latino Research Partnership
International Latino Research Partnership

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.

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). 8-10 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. 4 Research interviews will be conducted to assess outcomes, for patients in both the intervention and usual care arms.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Substance Use (Drugs, Alcohol)
Behavioral: Integrated Intervention for Dual Problems and Early Action
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.
  • Active Comparator: IIDEA
    Patients in the Integrated Intervention for Dual Problems and Early Action (IIDEA) arm will receive the 8-10 session intervention administered in person and via telephone.
    Intervention: Behavioral: Integrated Intervention for Dual Problems and Early Action
  • No Intervention: Usual Care
    Patients in this arm receive usual care for dual-diagnosis symptoms of mental health and substance use.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
360
August 2016
August 2016   (final data collection date for primary outcome measure)

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:

  • History of psychosis, mania or psychotic symptoms using the IMPACT study screener
  • 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 o Paykel suicide questionnaire)
Both
18 Years to 70 Years
No
Contact: Margarita Alegria, Ph.D. 617-503-8447 malegria@charesearch.org
United States,   Spain
 
NCT02038855
CHA-IRB-0910/06/12, R01DA034952-01A1
No
Cambridge Health Alliance
Cambridge Health Alliance
  • Hospital Vall d'Hebron
  • Universidad Autonoma de Madrid
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Margarita Alegria, Ph.D. CMMHR, Cambridge Health Alliance and Harvard Medical School
Principal Investigator: Enrique Baca-Garcia, Ph.D. Universidad Autonoma de Madrid
Principal Investigator: Francisco Collazos, MD Vall d'Hebron University Hospital
Cambridge Health Alliance
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP