3/4 Adapting Treatments for Suicidal College Students: A Multisite Trial

3/4 调整自杀大学生的治疗方法：多中心试验

• 批准号: 10427331
• 负责人: JOHN R SEELEY
• 金额: $ 60.25万
• 依托单位: UNIVERSITY OF OREGON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-04 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10427331
• 关键词: Address; Age; Algorithms; Base Sequence; Behavior; Borderline Personality Disorder; Caring; Cause of Death; Characteristics; Client; Clinical Trials; Clinical effectiveness; Cognition; Consultations; Counseling; Data; Development; Dialectical behavior therapy; Distress; Ecological momentary assessment; Enrollment; Evidence based intervention; Experimental Designs; Feeling suicidal; Heterogeneity; Individual; Intervention; Maintenance; Mediating; Mediator of activation protein; Mental Health Services; Methods; Nevada; Oregon; Participant; Pattern; Phase; Pilot Projects; Process; Provider; Public Health; Randomized; Research Project Grants; Resources; Risk; Risk Factors; Risk Reduction; Role; Sampling; Sequential Multiple Assignment Randomized Trial; Services; Severities; Sexual and Gender Minorities; Site; Specific qualifier value; Stress; Students; Suicide; Suicide attempt; Telephone; Testing; Text; Time; Treatment outcome; Universities; Use Effectiveness; Work; adaptive intervention; attentional bias; base; care seeking; clinical decision-making; college; comparative efficacy; cost effectiveness; data management; dosage; effectiveness evaluation; emerging adulthood; emotion regulation; evidence base; follow-up; implementation barriers; implementation evaluation; implementation framework; implementation outcomes; implementation science; improved; individualized medicine; innovation; multi-site trial; non-suicidal self injury; peer; primary outcome; process evaluation; recruit; response; secondary outcome; skills; success; suicidal; suicidal behavior; suicidal risk; theories; treatment as usual; treatment effect; treatment response; treatment strategy; university student

Project Summary Suicide is the 2nd leading cause of death among college students and suicidal ideation and suicide-related behaviors are a frequent presenting problem at college counseling centers (CCCs), which are overburdened. Studies show that some students respond rapidly to treatment, whereas others require considerably more resources. Evidence-based adaptive treatment strategies (ATSs) are needed to address this heterogeneity in responsivity and complexity. ATSs individualize treatment via decision rules specifying how the type and intensity of an intervention can be sequenced based on risk factors, response, or compliance. We are proposing a multisite study to investigate ATSs through a SMART (sequential, multiple assignment, randomized trial) to address suicidal risk in treatment-seeking college students. This multisite study (University of Nevada, Reno; Duke University, University of Oregon; Rutgers University), submitted in response to RFA- MH-18-700, Collaborative R01s for Clinical Trials, will enroll moderately to severely suicidal college students in the “emerging adulthood” phase (ages 18-25) seeking services at CCCs. This SMART will have two stages of intervention. In the first stage, 700 participants from four CCCs will be randomized to 4-8 weeks of: 1) a suicide-focused treatment – Collaborative Assessment and Management of Suicidality (CAMS) or 2) Treatment as Usual (TAU). Sufficient responders to either intervention will discontinue services/be stepped down. Non- responders will be re-randomized to one of two second-stage higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT), which includes individual therapy, skills groups, and phone/text coaching for the clients and peer consultation for the therapists. The aims of this research project are to 1) compare the efficacy of the four ATSs in reducing students’ suicidal ideation, non-suicidal self-injury, and suicide attempts; 2) evaluate whether, as hypothesized, a sequence that starts with a suicide-focused treatment approach (i.e., CAMS) is more effective in reducing suicidal risk than TAU; 3) determine whether, as hypothesized, a more comprehensive, suicide-focused approach (i.e., DBT) is more helpful as a second stage intervention for insufficient responders, relative to a less intensive suicide-focused approach (i.e., CAMS); 4) assess the mechanisms of change leading to reduced suicidal risk for each treatment; specifically, to evaluate suicidal cognitions as a mediator in CAMS and emotion regulation-based processes and use of skills as mediators in DBT; 5) examine baseline factors as predictors and/or moderators of treatment outcome; 6) evaluate the dissemination potential and cost effectiveness of using these ATSs within a CCC setting. This study will provide essential guidance to CCCs on how to best allocate limited resources to alleviate an increasing public health crisis.

项目概要 自杀是大学生第二大死因，自杀意念与自杀相关 行为问题是大学咨询中心（CCC）经常出现的问题，这些中心负担过重。 研究表明，一些学生对治疗反应迅速，而另一些学生则需要更多 资源。需要基于证据的适应性治疗策略（ATS）来解决这种异质性 响应性和复杂性。 ATS 通过决策规则来个性化治疗，指定类型和 干预的强度可以根据风险因素、反应或依从性进行排序。我们是 提出一项多地点研究，通过 SMART（顺序、多重分配、 随机试验）来解决寻求治疗的大学生的自杀风险。这项多地点研究（大学 内华达州里诺市；杜克大学、俄勒冈大学；罗格斯大学），响应 RFA 提交- MH-18-700，临床试验合作 R01，将招募中度至重度自杀大学生 “成年初期”阶段（18-25 岁）在 CCC 寻求服务。此 SMART 将分为两个阶段 干涉。在第一阶段，来自 4 个 CCC 的 700 名参与者将被随机分配到 4-8 周的组中：1) 以自杀为中心的治疗 – 自杀倾向协同评估和管理 (CAMS) 或 2) 治疗 和往常一样（TAU）。对任何一种干预措施都有足够的响应者将停止服务/被下台。非- 响应者将被重新随机分配到两个第二阶段更高强度/剂量干预选项之一 额外 4-16 周：1) CAMS（继续或首次实施）或 2) 综合 辩证行为疗法 (DBT)，包括个体治疗、技能小组和电话/短信辅导 为客户提供咨询，为治疗师提供同行咨询。该研究项目的目的是 1) 比较 四种 ATS 在减少学生自杀意念、非自杀性自残和自杀企图方面的功效； 2）评估是否如假设的那样，以自杀为中心的治疗方法开始的序列（即， CAMS）在降低自杀风险方面比 TAU 更有效； 3）确定是否如假设的那样，更 全面的、以自杀为中心的方法（即 DBT）作为第二阶段干预更有帮助 相对于强度较低的以自杀为中心的方法（即 CAMS），响应者不足； 4）评估 导致每种治疗自杀风险降低的变化机制；具体来说，评估自杀倾向 认知作为 CAMS 和基于情绪调节的过程的中介，以及使用技能作为中介 二苯并噻唑； 5）检查基线因素作为治疗结果的预测因素和/或调节因素； 6）评估 在 CCC 环境中使用这些苯丙胺类兴奋剂的传播潜力和成本效益。这项研究将 就如何最好地分配有限的资源来缓解日益增长的公众压力，向 CCC 提供重要指导 健康危机。