Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

NCT02600741 | Completed

• 2 other identifiers: CR106399R092670SCH4043
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 34

Brief Summary

The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.

Conditions

Schizophrenia

Keywords

Schizophrenia; Caregiver; Psycho-education and skills training; Paliperidone Palmitate; Oral Antipsychotic

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Failures Over 12 Months

  Treatment failure is defined as any of the following: 1. Psychiatric hospitalization 2. Psychiatric emergency room (ER) visit 3. Crisis center visit 4. Mobile crisis unit intervention 5. Arrest/Incarceration 6. Suicide or suicide attempt.

  12 months

Secondary Outcomes (6)

• Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12

  Month 12

• Number of Treatment Failures in Patients Taking Oral Antipsychotics

  12 months

• Number of Treatment Failures in Patients Taking Paliperidone Palmitate

  12 months

• Patient Recovery Based on Total Illness Management and Recovery (IMR) Score

  Month 6 and Month 12

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12

  Month 12

Study Arms (2)

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.

Other: Caregiver psycho-education and skills training; Drug: Paliperidone palmitate; Drug: Chlorpromazine; Drug: Droperidol; Drug: Fluphenazine; Drug: Haloperidol; Drug: Loxapine; Drug: Perphenazine; Drug: Pimozide; Drug: Prochlorperazine; Drug: Thiothixene; Drug: Thioridazine; Drug: Trifluoperazine; Drug: Aripiprazole; Drug: Asenapine; Drug: Clozapine; Drug: Iloperidone; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone; Drug: Ziprasidone

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.

Other: Caregiver support available at the study site; Drug: Paliperidone palmitate; Drug: Chlorpromazine; Drug: Droperidol; Drug: Fluphenazine; Drug: Haloperidol; Drug: Loxapine; Drug: Perphenazine; Drug: Pimozide; Drug: Prochlorperazine; Drug: Thiothixene; Drug: Thioridazine; Drug: Trifluoperazine; Drug: Aripiprazole; Drug: Asenapine; Drug: Clozapine; Drug: Iloperidone; Drug: Olanzapine; Drug: Paliperidone; Drug: Quetiapine; Drug: Risperidone; Drug: Ziprasidone

Interventions

Caregiver psycho-education and skills training OTHER

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.

Study group 1

Caregiver support available at the study site OTHER

Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.

Study group 2

Paliperidone palmitate DRUG

Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.

Study group 1; Study group 2

Chlorpromazine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Droperidol DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Fluphenazine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Haloperidol DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Loxapine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Perphenazine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Pimozide DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Prochlorperazine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Thiothixene DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Thioridazine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Trifluoperazine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Aripiprazole DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Asenapine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Clozapine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Iloperidone DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Olanzapine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Paliperidone DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Quetiapine DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Risperidone DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Ziprasidone DRUG

Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.

Study group 1; Study group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of a paired patient and caregiver. A caregiver is defined as a person who has accepted responsibility for providing the patient with both assistance with activities of daily living and protection from harm. The patient will have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.

You may qualify if:

• A) Caregivers
• 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

You may not qualify if:

• A) Caregivers
• 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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (34)

Unknown Facility

Bullhead City, Arizona, United States

Location

Unknown Facility

Oceanside, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Farmington, Connecticut, United States

Location

Unknown Facility

Lauderdale Lakes, Florida, United States

Location

Unknown Facility

Leesburg, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Orange City, Florida, United States

Location

Unknown Facility

Tallahassee, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Granite City, Illinois, United States

Location

Unknown Facility

Lombard, Illinois, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Bloomington, Indiana, United States

Location

Unknown Facility

Lawrenceburg, Indiana, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Grand Rapids, Michigan, United States

Location

Unknown Facility

Mount Pleasant, Michigan, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Eugene, Oregon, United States

Location

Unknown Facility

Lincoln, Rhode Island, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Richland, Washington, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

Related Publications (1)

• 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.

  PMID: 35436231 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate; Chlorpromazine; Droperidol; Fluphenazine; Haloperidol; Loxapine; Perphenazine; Pimozide; Prochlorperazine; Thiothixene; Thioridazine; Trifluoperazine; Aripiprazole; asenapine; Clozapine; iloperidone; Olanzapine; Quetiapine Fumarate; Risperidone; ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Butyrophenones; Ketones; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Dibenzoxazepines; Thioxanthenes; Xanthenes; Piperazines; Quinolones; Quinolines; Dibenzazepines; Benzodiazepines; Benzazepines; Dibenzothiazepines; Thiazepines; Thiepins; Pyrimidinones

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: November 9, 2015
• Study Start: July 24, 2015
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

US (34)