Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT ID: NCT02600741
Last Updated: 2019-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
296 participants
OBSERVATIONAL
2015-07-24
2018-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study group 1
Caregivers randomized to this group will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician.
Caregiver psycho-education and skills training
Caregivers will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period.
Paliperidone palmitate
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
Chlorpromazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Droperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Fluphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Haloperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Loxapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Perphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Pimozide
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Prochlorperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Thiothixene
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Thioridazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Trifluoperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Aripiprazole
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Asenapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Clozapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Iloperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Olanzapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Paliperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Quetiapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Risperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Ziprasidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Study group 2
Caregivers randomized to this group will receive whatever caregiver support that is customarily available at the study site, if any. Each patient will be paired with a caregiver and patients will continue their routine antipsychotic treatments prescribed by their treating physician.
Caregiver support available at the study site
Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.
Paliperidone palmitate
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
Chlorpromazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Droperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Fluphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Haloperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Loxapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Perphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Pimozide
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Prochlorperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Thiothixene
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Thioridazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Trifluoperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Aripiprazole
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Asenapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Clozapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Iloperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Olanzapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Paliperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Quetiapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Risperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Ziprasidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Interventions
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Caregiver psycho-education and skills training
Caregivers will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period.
Caregiver support available at the study site
Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.
Paliperidone palmitate
Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
Chlorpromazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Droperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Fluphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Haloperidol
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Loxapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Perphenazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Pimozide
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Prochlorperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Thiothixene
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Thioridazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Trifluoperazine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Aripiprazole
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Asenapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Clozapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Iloperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Olanzapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Paliperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Quetiapine
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Risperidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Ziprasidone
Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
Eligibility Criteria
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Inclusion Criteria
* Each caregiver must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate for the duration of the study
* Caregiver is able to have verbal interaction with the patient with schizophrenia, schizoaffective disorder, or schizophreniform disorder at least twice a week, per self-report
B) Patients
* Patients must have a clinical diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria for these disorders
* Patients must be receiving ongoing psychiatric treatment at the study site and must be receiving oral antipsychotics or paliperidone palmitate long acting therapy
Exclusion Criteria
* Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by the treatment team
* Caregiver has received structured or manualized psycho-education or skills training within 1 year prior to Screening B) Patients
* Patient is hospitalized (medical or psychiatric), incarcerated, or otherwise institutionalized at time of randomization
* Patient is considered to have significant potential for imminent harm to self and/or others as based on the judgment of the treatment team
* Patient is receiving assertive community treatment (ACT) or other high intensity case management services to prevent hospitalization
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_CHAIR
Janssen Scientific Affairs, LLC
Locations
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Bullhead City, Arizona, United States
Oceanside, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Lauderdale Lakes, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Orange City, Florida, United States
Tallahassee, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Granite City, Illinois, United States
Lombard, Illinois, United States
Springfield, Illinois, United States
Bloomington, Indiana, United States
Lawrenceburg, Indiana, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Mount Pleasant, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
New York, New York, United States
Staten Island, New York, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Lincoln, Rhode Island, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richland, Washington, United States
Spokane, Washington, United States
Countries
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References
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Mueser KT, Achtyes ED, Gogate J, Mancevski B, Kim E, Starr HL. Telehealth-Based Psychoeducation for Caregivers: The Family Intervention in Recent-Onset Schizophrenia Treatment Study. JMIR Ment Health. 2022 Apr 15;9(4):e32492. doi: 10.2196/32492.
Other Identifiers
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R092670SCH4043
Identifier Type: OTHER
Identifier Source: secondary_id
CR106399
Identifier Type: -
Identifier Source: org_study_id
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