The study will use a three-arm randomised controlled trial designed to test the effectiveness of the Safety Planning Intervention with structured follow-up (SPI+) and the Collaborative Assessment and Management of Suicidality (CAMS) compared with enhanced usual care. The primary outcomes measure will be suicidal events, defined as death by suicide, attempted suicide, preparatory acts toward imminent suicidal behaviour or suicidal ideation resulting in a change in emergency evaluation or inpatient admission. Secondary measures will be the number of suicide attempts and severity of suicidal ideation. The experimental interventions, SPI+ and CAMS, consist of up to eight sessions over approximately 8 weeks that are designed to manage (SPI+) or treat (CAMS) patient-identified \'drivers\' of suicidal thoughts and behaviours. Mechanisms and moderators of change will be evaluated to understand treatment impacts.
This study has been approved by the Seattle Children\'s Institutional Review Board and is monitored by external agencies including the University of Washington Institute for Translational Health Sciences, and a National Institute of Mental Health (NIMH)-appointed Data Safety and Monitoring Board. Trial results will help establish evidence towards safe and effective treatment strategies for youth transitioning from acute to outpatient care due to a suicidal crisis. The data will be shared with the NIMH Data Archives and disseminated through publications and conferences.
NCT05078970.
方法:该研究将使用一项三臂随机对照试验,旨在通过结构化随访(SPI)和自杀的协作评估和管理(CAMS)测试安全计划干预措施的有效性。主要结果指标将是自杀事件,定义为自杀死亡,企图自杀,针对即将发生的自杀行为或自杀意念的准备行为,导致急诊评估或住院的变化。次要措施将是自杀未遂的次数和自杀意念的严重程度。实验性干预措施,SPI+和CAMS,包括在大约8周内最多8次会议,旨在管理(SPI+)或治疗(CAMS)患者识别的自杀念头和行为的驱动因素。将评估变化的机制和调节因素,以了解治疗影响。
背景:这项研究已获得西雅图儿童机构审查委员会的批准,并受到包括华盛顿大学转化健康科学研究所在内的外部机构的监督。和国家心理健康研究所(NIMH)任命的数据安全和监测委员会。试验结果将有助于为因自杀危机而从急性护理过渡到门诊护理的年轻人提供安全有效的治疗策略的证据。这些数据将与NIMH数据档案共享,并通过出版物和会议传播。
背景:NCT05078970。