Development of a Recovery-Oriented Suicide Prevention Intervention With Peers for Clinical High Risk for Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard care
Standard care
干预措施: Standard Care (in control arm) (Behavioral)
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.
干预措施: Suicide Prevention Intervention (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: From enrollment to the 3-month follow-up assessment
Retention Rate
时间窗: From enrollment to the 3-month follow-up assessment
Intervention Attendance
时间窗: From enrollment to the end of the intervention at 9 weeks
Acceptability
时间窗: The 3 month follow-up assessment
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.
次要结局
- Change from Baseline to 3-Month Follow-Up in Personal Recovery(From baseline to the 3-month follow-up assessment)
- Change from Baseline to 3-Month Follow-Up in Suicide Prevention Strategy Recall(From baseline to the 3-month follow-up assessment)
- Outpatient Mental Health Treatment Service Utilization(From baseline to the 3-month follow-up assessment)
- Suicide-Related Crisis Service Utilization(From baseline to the 3-month follow-up assessment)
- Change from Baseline to 3-Month Follow-Up in Social Functioning(From baseline to the 3-month follow-up assessment)
- Change from Baseline to 3-Month Follow-Up of Suicide Ideation Severity(From baseline to the 3-month follow-up assessment)
- Change from Baseline to 3-Month Follow-Up in Role Functioning(From baseline to the 3-month follow-up assessment)
研究者
Samantha A. Chalker
Assistant Professor
University of California, San Diego