Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Development of a Recovery-Oriented Suicide Prevention Intervention With Peers for Clinical High Risk for Psychosis
Young people at clinical high risk for psychosis are more likely to experience suicide thoughts than the general population, but there are few suicide prevention programs designed specifically for them. This study will develop and evaluate a recovery-oriented suicide prevention group program for young people at clinical high risk for psychosis.
The program will be led by a clinician and a peer with lived experience. It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use suicide prevention strategies developed during the program. Caregivers will also be invited to participate in a session to learn ways to support their young person.
The study will first gather feedback from participants, caregivers, clinicians, and community advisors to refine the program. Researchers will then compare the program plus standard care with standard care alone to determine whether it improves personal recovery and increases participants' ability to remember and use suicide prevention strategies. Researchers will also collect feedback from participants and program staff to better understand how the program can be integrated into early psychosis services.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Young people at clinical high risk for psychosis experience elevated rates of suicide thoughts and behaviors, yet there are few suicide prevention interventions designed specifically for this population. This study will develop and evaluate a recovery-oriented suicide prevention group intervention that integrates peer support with clinician-led care and is designed for implementation within early psychosis services.
This hybrid type 1 effectiveness-implementation study will be conducted over approximately three years at two early psychosis programs. During the first phase, the intervention will be refined through input from young people with lived experience, caregivers, clinicians, and community advisors, followed by an open trial to evaluate feasibility, acceptability, fidelity, and any additional adaptations needed before broader evaluation.
The second phase will consist of a pilot randomized controlled trial comparing the intervention plus standard care with standard care alone. The study will examine preliminary effects on personal recovery and participants' ability to remember and use suicide prevention strategies.
The final phase will evaluate factors that may influence future implementation of the intervention in routine early psychosis services. Interviews with participants and program staff will be used to identify barriers and facilitators to implementation and to inform resources that support future adoption and sustainability if the intervention proves promising.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Samantha Chalker, PhD
- Número de teléfono: 619-821-9415
- Correo electrónico: schalker@health.ucsd.edu
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- University of California, Los Angeles
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Contacto:
- Carrie Bearden, PhD
- Número de teléfono: 310-206-2983
- Correo electrónico: cbearden@mednet.ucla.edu
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San Diego, California, Estados Unidos, 92161
- University of California, San Diego
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Contacto:
- Heline Mirzakhanian, PhD
- Número de teléfono: 619-543-3199
- Correo electrónico: carelab@health.ucsd.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Young Person Inclusion Criteria:
- symptoms of clinical high risk for psychosis in the last two years
- lifetime active suicide ideation and/or lifetime suicide behavior
- has a caregiver willing to participate
Young Person Exclusion Criterion:
- not able to read and write in English
Caregiver Inclusion Criteria:
- has a familial relationship with the young person participant
- has at least 4 hours of face-to-face contact with the patient participant every week, even if they do not live together
Caregiver Exclusion Criteria: None
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Administrator/Clinician Inclusion Criteria:
- employed at the University of California, San Diego or University of California, Los Angeles early psychosis program
Administrator/Clinician Exclusion Criteria: None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Cuidado estándar
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Coordinated speciality care for early psychosis
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Experimental: Suicide Prevention Intervention
The program will be led by a clinician and a peer with lived experience.
It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use the suicide prevention strategies developed during the program.
Caregivers will also be invited to participate in a session to learn ways to support their young person and promote recovery and stability.
This program will be in addition to standard coordinated speciality care for early psychosis.
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The program will be led by a clinician and a peer specialist with lived experience.
It will help participants identify reasons for living, build hope, set meaningful recovery goals, strengthen social connections, and learn strategies to better remember and use the suicide prevention strategies developed during the program.
Caregivers will also be invited to participate in a session to learn ways to support their young person and promote recovery and stability.
This program will be in addition to coordinated speciality care for early psychosis.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Recruitment Rate
Periodo de tiempo: From enrollment to the 3-month follow-up assessment
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From enrollment to the 3-month follow-up assessment
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Retention Rate
Periodo de tiempo: From enrollment to the 3-month follow-up assessment
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From enrollment to the 3-month follow-up assessment
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Intervention Attendance
Periodo de tiempo: From enrollment to the end of the intervention at 9 weeks
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From enrollment to the end of the intervention at 9 weeks
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Acceptability
Periodo de tiempo: The 3 month follow-up assessment
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Intervention acceptability will be assessed using the Acceptability of Intervention Measure (AIM).
Total scores range from 4 to 20, with higher scores indicating greater perceived acceptability of the intervention.
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The 3 month follow-up assessment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline to 3-Month Follow-Up in Personal Recovery
Periodo de tiempo: From baseline to the 3-month follow-up assessment
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Personal recovery will be assessed using the Recovery Assessment Scale-41 (RAS-41).
Total scores range from 41 to 205, with higher scores indicating greater personal recovery.
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From baseline to the 3-month follow-up assessment
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Change from Baseline to 3-Month Follow-Up in Suicide Prevention Strategy Recall
Periodo de tiempo: From baseline to the 3-month follow-up assessment
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Suicide prevention strategy recall will be assessed by the Suicide Prevention Strategy Recall Task, which collects a count of the number of strategies recalled with a higher number indicating more strategies recalled.
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From baseline to the 3-month follow-up assessment
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Outpatient Mental Health Treatment Service Utilization
Periodo de tiempo: From baseline to the 3-month follow-up assessment
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Outpatient Treatment Service Utilization will be assessed as a composite count of outpatient mental health treatment appointments attended during the follow-up period.
Data will be abstracted from the electronic medical record and supplemented with participant self-report to capture services received outside the health system.
Services include individual therapy, group therapy, family therapy, medication management, and other outpatient mental health visits.
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From baseline to the 3-month follow-up assessment
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Suicide-Related Crisis Service Utilization
Periodo de tiempo: From baseline to the 3-month follow-up assessment
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Crisis Service Utilization will be assessed using a composite measure of suicide-related crisis service encounters.
Data will be abstracted from the electronic medical record and supplemented with participant self-report to capture services received outside the health system.
Services include emergency department visits, emergency psychiatric services, and inpatient psychiatric hospitalizations.
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From baseline to the 3-month follow-up assessment
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Change from Baseline to 3-Month Follow-Up in Social Functioning
Periodo de tiempo: From baseline to the 3-month follow-up assessment
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Social functioning will be assessed using the Global Functioning: Social Scale (GF: Social).
The scale ranges from 1 to 10, with higher scores indicating better social functioning.
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From baseline to the 3-month follow-up assessment
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Change from Baseline to 3-Month Follow-Up of Suicide Ideation Severity
Periodo de tiempo: From baseline to the 3-month follow-up assessment
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Suicide ideation severity will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) Severity of Ideation subscale.
Scores range from 0 to 5, where 0 indicates no suicide ideation and higher scores indicate greater severity of suicide ideation.
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From baseline to the 3-month follow-up assessment
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Change from Baseline to 3-Month Follow-Up in Role Functioning
Periodo de tiempo: From baseline to the 3-month follow-up assessment
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Role functioning will be assessed using the Global Functioning: Role Scale (GF: Role).
The scale ranges from 1 to 10, with higher scores indicating better role functioning.
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From baseline to the 3-month follow-up assessment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Espectro de esquizofrenia y otros trastornos psicóticos
- Desordenes mentales
- Síntomas de comportamiento
- Comportamiento auto agresivo
- Comportamiento
- Desórdenes psicóticos
- Suicidio
- Ideación suicida
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- R01MH144654 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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