Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial.

Advancing Suicide Intervention Strategies for Teens (ASSIST): study protocol for a multisite randomised controlled trial.
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DOI:
10.1136/bmjopen-2023-074116
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发表时间:
2023-12-12
期刊:
影响因子:
2.9
通讯作者:
--
中科院分区:
医学3区
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--
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在青少年因自杀而接受紧急护理后,需要采取简短的干预措施来降低自杀风险。该研究将使用三组随机对照试验,旨在测试安全计划干预与结构化随访(SPI+)以及自杀协作评估和管理(CAMS)与强化常规护理相比的有效性。主要结局指标是自杀事件,定义为自杀死亡、自杀未遂、针对即将发生的自杀行为或自杀意念的准备行动,导致紧急评估或住院治疗发生变化。次要指标是自杀企图的次数和自杀意念的严重程度。实验性干预措施 SPI+ 和 CAMS 包括为期约 8 周的最多 8 个疗程,旨在管理 (SPI+) 或治疗 (CAMS) 患者确定的自杀想法和行为的“驱动因素”。将评估变化的机制和调节因素,以了解治疗的影响。这项研究已获得西雅图儿童机构审查委员会的批准,并受到外部机构的监督,包括华盛顿大学转化健康科学研究所和国家心理健康研究所 (NIMH) 指定的数据安全和监测委员会。试验结果将有助于建立证据,为因自杀危机而从急性护理过渡到门诊护理的青少年制定安全有效的治疗策略。这些数据将与 NIMH 数据档案馆共享,并通过出版物和会议传播。 NCT05078970。
Brief interventions that reduce suicide risk following youth’s experience with acute care due to suicidality are needed. 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.
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