Promoting Adherence to Treatment in Schizophrenia

Study Overview
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Brief Summary
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The project evaluates a culturally adapted, family-based intervention designed to promote treatment adherence among Mexican-Americans with schizophrenia using a randomized, controlled design in a public mental health setting. Mexican-American patients with schizophrenia and their families were randomly assigned to either: 1) one year of multi- family groups that emphasize the importance of attitudes towards adherence, subjective norms, and self-perceived and actual adherence skills in maintaining adherence, added to ongoing customary outpatient care; 2) standard multi-family groups without an emphasis on medication adherence, added to customary outpatient care; or 3) customary outpatient care only (monthly pharmacotherapy sessions and additional services as clinically needed). The study hypotheses are that subjects assigned to the adapted multi-family group would have better medication adherence, less psychiatric symptoms and fewer psychiatric hospitalizations throughout the course of the study (one year of treatment and one year of follow up) compared to the comparison conditions.

Detailed Description
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As above

Official Title
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Promoting Adherence to Treatment in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: multifamily group-adherence
* Behavioral: multifamily group-standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder; Between 18 and 50 years of age; Of Mexican origin and speaks Spanish fluently; Was without antipsychotic medication without medical authorization for one continuous week in the month prior to hospitalization; Was living with his/her family of origin immediately preceding the inpatient stay and would return to live with his/her family after discharge; and The patient and at least one family member were willing to participate. Exclusion Criteria: Patient on conservatorship or legal guardian status

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multifamily group-adherence<br>multifamily group treatment with a focus on improving adherence to antipsychotic medication | Behavioral: multifamily group-adherence<br>* multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior<br>|
| Active Comparator: multifamily group-standard<br>multifamily group focused on problems identified by group participants | Behavioral: multifamily group-standard<br>* multifamily groups held twice a month focused on general problem solving method<br>|
| No Intervention: treatment as usual<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who are Hospitalized in a Psychiatric Inpatient Unit | Psychiatric hospitalization will be monitored through the use of the Los Angeles County Department of Mental Health Management Information System. This allows for the data capture of all participants who are hospitalized in an inpatient unit anywhere in Los Angeles County throughout the two-yaer course of the study. Although the primary outcome variable is whether or not a participant has been hospitalized within a given assessment period, the number of hospitalizations and the number of days hospitalized across all assessment periods will be assessed, as well. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who are at least 80% adherent to their antipsychotic medication regimens during a particular assessment period | Multi-modal method of assessing medication adherence including pill count, pharmacy records and interviews of patient, key relative and treating psychiatrist. Using the Treatment Compliance Interview, participants will be rated as either non-adherent (less than 50% adherence), partially adherent (50%-79% adherent) or fully adherent (80% or greater). | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication adherence, schizophrenia, Mexican American, multifamily groups