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Completed

NCT Number: NCT02600741

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bullhead City, Arizona, United States

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About this study

This is a randomized, open-label, parallel group study of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder and their caregivers. Study will consist of a paired patient and caregiver. Patients will receive routine treatment, which may include oral antipsychotics or paliperidone palmitate, as directed by their treating physician. Caregivers for patients whose routine treatment is paliperidone palmitate will be randomized to receive either a study-provided caregiver psycho-education and skills training or usual caregiver support. Caregivers for patients whose routine treatment is oral antipsychotics will be randomized to the same Study Groups: Study Group 1: Study-provided caregiver psycho-education and skills training. Study Group 2: Usual caregiver support (caregiver support that is customarily provided by the study site, if any). Patients-caregiver pairs will be followed for up to 12 months following baseline assessment. Cumulative number of treatment failures over 12 months will be assessed primarily.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Caregiver support available at the study site

Other

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

Paliperidone palmitate

Drug

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

Chlorpromazine

Drug

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

Droperidol

Drug

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

Fluphenazine

Drug

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

Haloperidol

Drug

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

loxapine

Drug

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

Perphenazine

Drug

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

Pimozide

Drug

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

prochlorperazine

Drug

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

Thiothixene

Drug

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

Thioridazine

Drug

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

Trifluoperazine

Drug

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

Aripiprazole

Drug

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

asenapine

Drug

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

Clozapine

Drug

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

iloperidone

Drug

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

Olanzapine

Drug

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

Paliperidone

Drug

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

Quetiapine

Drug

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

Risperidone

Drug

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

Ziprasidone

Drug

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

Primary outcomes

  1. Number of Treatment Failures Over 12 Months

    Time frame: 12 months

    Treatment failure is defined as any of the following:

    • Psychiatric hospitalization
    • Psychiatric emergency room (ER) visit
    • Crisis center visit
    • Mobile crisis unit intervention
    • Arrest/Incarceration
    • Suicide or suicide attempt.

Secondary outcomes

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

    Time frame: Month 12

    The IEQ is designed to measure levels of caregiver consequences among family members and friends of patients with schizophrenia. The 31 items included in this scale are answered on a 5 point Likert response scale and address consequences among 4 dimensions (tension, supervision, worrying, and urging).

  2. Number of Treatment Failures in Patients Taking Oral Antipsychotics

    Time frame: 12 months

    Treatment failure is defined as any of the following:

    • Psychiatric hospitalization
    • Psychiatric emergency room (ER) visit
    • Crisis center visit
    • Mobile crisis unit intervention
    • Arrest/Incarceration
    • Suicide or suicide attempt.

  3. Number of Treatment Failures in Patients Taking Paliperidone Palmitate

    Time frame: 12 months

    Treatment failure is defined as any of the following:

    • Psychiatric hospitalization
    • Psychiatric emergency room (ER) visit
    • Crisis center visit
    • Mobile crisis unit intervention
    • Arrest/Incarceration
    • Suicide or suicide attempt.

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

    Time frame: Month 6 and Month 12

    The IMR program was developed in order to help patients with schizophrenia or major mood disorders learn how to manage their illnesses more effectively in the context of pursuing their personal goals.

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

    Time frame: Month 12

    The CGI-S rating scale is used to rate the severity of a patient's overall clinical condition on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) to 7 (amongst the most severely ill patients).

  6. Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12

    Time frame: Month 12

    The 12-item Short Form Health Survey (SF-12) is a self-administered, generic, 12-item questionnaire designed to cover the same 8 domains of functional health status and well-being included in the longer 36-item Short Form Health Survey (SF 36): physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

Sponsors and collaborators

Lead sponsor

Janssen Scientific Affairs, LLC

Industry

Registry information

Official study title

A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic Treatment

Acronym: FIRST

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2015
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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