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- Ensaio Clínico NCT07756567
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Samantha Chalker, PhD
- Número de telefone: 619-821-9415
- E-mail: schalker@health.ucsd.edu
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90095
- University of California, Los Angeles
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Contato:
- Carrie Bearden, PhD
- Número de telefone: 310-206-2983
- E-mail: cbearden@mednet.ucla.edu
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San Diego, California, Estados Unidos, 92161
- University of California, San Diego
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Contato:
- Heline Mirzakhanian, PhD
- Número de telefone: 619-543-3199
- E-mail: carelab@health.ucsd.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
***
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Cuidado padrão
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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.
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recruitment Rate
Prazo: 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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|
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Retention Rate
Prazo: From enrollment to the 3-month follow-up assessment
|
From enrollment to the 3-month follow-up assessment
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|
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Intervention Attendance
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline to 3-Month Follow-Up in Personal Recovery
Prazo: From baseline to the 3-month follow-up assessment
|
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
Prazo: 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
Prazo: 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
Prazo: From baseline to the 3-month follow-up assessment
|
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
Prazo: From baseline to the 3-month follow-up assessment
|
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
Prazo: From baseline to the 3-month follow-up assessment
|
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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Espectro da Esquizofrenia e Outros Transtornos Psicóticos
- Transtornos Mentais, Desordem Mental
- Sintomas Comportamentais
- Comportamento autolesivo
- Comportamento
- Transtornos Psicóticos
- Suicídio
- Ideação Suicida
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- R01MH144654 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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