Substance Use (Drugs, Alcohol) Clinical Trial
— ILRPOfficial title:
International Latino Research Partnership
| Verified date | April 2017 |
| Source | Massachusetts General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 360 |
| Est. completion date | February 28, 2017 |
| Est. primary completion date | February 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Vall d'Hebron University Hospital | Barcelona | Catalonia |
| Spain | Universidad Autonoma de Madrid Medical School | Madrid | |
| United States | Cambridge Health Alliance | Somerville | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Massachusetts General Hospital | Hospital Vall d'Hebron, National Institute on Drug Abuse (NIDA), Universidad Autonoma de Madrid |
United States, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline, 2 months, 4 months, 6 months, 12 months | |
| Primary | 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. | Baseline, 2 months, 4 months, 6 months, 12 months | |
| Primary | 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. | Baseline, 2 months, 4 months, 6 months, 12 months | |
| Secondary | 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). | Baseline, 2 months, 4 months, 6 months, 12 months | |
| Secondary | 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. | Baseline, 2 months, 4 months, 6 months, 12 months | |
| Secondary | Patient Health Questionnaire (PHQ-9) (change) | The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder. | Baseline, 2 months, 4 months, 6 months, 12 months | |
| Secondary | Hopkins Symptom Checklist-20 | The HSCL-20 is a symptom inventory for depression that indicates severity of psychological distress. | Baseline, 2 months, 4 months, 6 months, 12 months |