2/4 Adapting Treatments for Suicidal College Students: A Multisite Trial

2/4 针对自杀大学生的调整治疗：多地点试验

• 批准号: 10201457
• 负责人: SCOTT N COMPTON
• 金额: $ 74.79万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10201457
• 关键词: Address; Age; Algorithms; Base Sequence; Behavior; Caring; Cause of Death; Characteristics; Client; Clinical Trials; Clinical effectiveness; Cognition; Consultations; Counseling; Data; Development; Dialectical behavior therapy; Distress; Ecological momentary assessment; Enrollment; Evaluation; Evidence based intervention; Experimental Designs; Feeling suicidal; Heterogeneity; Individual; Intervention; Maintenance; Mediating; Mediator of activation protein; Mental Health; 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 framework; implementation outcomes; implementation science; improved; individualized medicine; innovation; multi-site trial; non-suicidal self injury; peer; primary outcome; 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.

项目摘要 自杀是大学生死亡的第二大原因，自杀意念和自杀相关 行为问题是高校心理咨询中心（CCCs）经常出现的问题，其负担过重。 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的治疗。 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， 可以根据风险因素、反应或依从性对干预的强度进行排序。我们 建议通过SMART（顺序，多重分配， 随机试验），以解决寻求治疗的大学生的自杀风险。这项多中心研究（大学 （内华达州、里诺、杜克大学、俄勒冈州大学、罗格斯大学），针对RFA提交- MH-18-700，临床试验的协作R 01，将招募中度至重度自杀的大学生， “成年初显”阶段（18-25岁），在社区中心寻求服务。该SMART将分为两个阶段， 干预在第一阶段，来自四个CCC的700名参与者将被随机分配到4-8周的： 以自杀为重点的治疗-自杀行为的合作评估和管理（CAMS）或2）治疗 如图所示（TAU）任何一种干预措施的足够响应者将停止服务/下台。非 应答者将被重新随机分配至两个第二阶段较高强度/剂量干预选项之一， 额外4-16周：1）CAMS（持续或首次给药）或2）综合 辩证行为疗法（DBT），包括个别治疗，技能小组和电话/短信辅导 为来访者提供咨询，为治疗师提供同行咨询。本研究项目的目的是：1）比较 四种ATS在降低学生自杀意念、非自杀性自伤和自杀企图方面的功效; 2)评估是否如假设的那样，以自杀为重点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， 全面的，以自杀为重点的方法（即，DBT）作为第二阶段干预更有帮助， 反应不足，相对于不太密集的自杀为重点的方法（即，（4）评估 每种治疗导致自杀风险降低的变化机制;具体而言，评估自杀风险 认知作为CAMS和情绪调节为基础的过程中的调解人，并使用技能作为调解人， DBT; 5）检查基线因素作为治疗结果的预测因子和/或调节因子; 6）评估 在CCC环境中使用这些ATS的传播潜力和成本效益。本研究将 就如何最好地分配有限的资源，以减轻日益增加的公共 健康危机。