International Latino Research Partnership (ILRP)
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|ClinicalTrials.gov Identifier: NCT02038855|
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Substance Use (Drugs, Alcohol)||Behavioral: Integrated Intervention for Dual Problems and Early Action||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||International Latino Research Partnership|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||February 28, 2017|
|Actual Study Completion Date :||February 28, 2017|
Active Comparator: IIDEA
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.
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.
No Intervention: Usual Care
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.
- Addiction Severity Index (ASI) - Alcohol (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months, 12 months ]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, 2 months, 4 months, 6 months, 12 months ]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, 2 months, 4 months, 6 months, 12 months ]Technical analysis of a biological specimen (urine) to determine the presence or absence of specified parent drugs or their metabolites.
- Generalized Anxiety Disorder 7-item (GAD-7) Scale (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months, 12 months ]The GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
- PTSD Checklist for DSM-V (PCL-5) [ Time Frame: Baseline, 2 months, 4 months, 6 months, 12 months ]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) [ Time Frame: Baseline, 2 months, 4 months, 6 months, 12 months ]The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder.
- Hopkins Symptom Checklist-20 [ Time Frame: Baseline, 2 months, 4 months, 6 months, 12 months ]The HSCL-20 is a symptom inventory for depression that indicates severity of psychological distress.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038855
|United States, Massachusetts|
|Cambridge Health Alliance|
|Somerville, Massachusetts, United States, 02143|
|Vall d'Hebron University Hospital|
|Barcelona, Catalonia, Spain|
|Universidad Autonoma de Madrid Medical School|
|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|