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Psych Congress  

The Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) Study

Erica Elefant, MSW, RN
Branislav Mancevski, MD
Larry Alphs, MD, PhD
Carmela Benson, MS
Kim Cheshire-Kinney, BA
Carol Price, MS
Lian Mao, PhD
Edward Kim, MD, MBA
Janssen Scientific Affairs, LLC

Background: Caregiver education and training can positively impact individuals with psychotic disorders and his or her caregivers. This study evaluates the clinical effects of psychosocial education and skills training when delivered to caregivers of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder. Methods: FIRST is a randomized, open-label, parallel-group trial designed to evaluate effects of study provided caregiver psychoeducation and skills training compared to usual caregiver support on patient treatment failures (ie, psychiatric hospitalizations, psychiatric emergency department or crisis center visits, arrests/incarcerations, or suicides/suicide attempts) over a 12-month period. FIRST includes clinician-provided individualized psychoeducation and skills training for caregivers via interactive, real-time technology. Patient-caregiver dyads will be stratified according to patients' (aged 18-35 years with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder) routine antipsychotic treatment taken at time of study entry (paliperidone palmitate or oral antipsychotic). Caregiver members of these dyads are then randomly assigned to one of 2 treatment groups: 1) caregivers receiving study-provided psychoeducation and skills training and 2) caregivers receiving routine psychosocial support. Patients will receive antipsychotic treatment as directed by their physician during the study. Results: Enrollment is underway and will target 300 patient/caregiver pairs with ~50% of patients who are currently receiving PP at screening. Conclusion: This study seeks to improve future treatment interventions by evaluating the interaction of medication treatment with psychosocial training. Specifically, FIRST will help establish the value of remotely delivered skills training for caregivers of patients recently diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder.

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