Modeling the Impact of Group Membership Turnover in Ecologically-Valid Treatment

模拟群体成员流动对生态有效处理的影响

• 批准号: 7822738
• 负责人: ANTONIO A MORGAN-LOPEZ
• 金额: $ 32.95万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7822738
• 关键词: Accounting; Address; Admission activity; Advocate; Aftercare; Alcohol or Other Drugs use; Alcoholism; Applications Grants; Area; Behavior Therapy; Budgets; Clinical; Clinical Trials Network; Communities; Confidence Intervals; Coupled; Data; Data Analyses; Data Set; Development; Drug abuse; Enrollment; Funding; Funding Agency; Goals; Grant; Group Therapy; Growth; Hand; Health Services Research; Health education; Holidays; Housing; Individual; Investigation; Joints; Measurement; Methodology; Methods; Modeling; Monitor; National Institute of Drug Abuse; Office Management; Outcome; Patients; Pattern; Positioning Attribute; Post-Traumatic Stress Disorders; Process; Protocols documentation; Publishing; Randomized Clinical Trials; Recovery; Research; Research Personnel; Safety; Series; Services; Simulate; Societies; Stifle joint; Structure; Substance Use Disorder; Substance abuse problem; System; Time; Translating; Trauma; Treatment Effectiveness; Treatment Efficacy; Treatment Protocols; Treatment outcome; United States; United States Substance Abuse and Mental Health Services Administration; Weight; Woman; Women' s Health; Work; alcoholism therapy; base; behavioral clinical trial; community setting; contextual factors; data modeling; design; effectiveness trial; efficacy trial; heuristics; indexing; innovation; interest; programs; response; substance abuse treatment; tool; treatment effect; treatment program; treatment trial

DESCRIPTION (provided by applicant): Increasing the connection between treatment research and treatment as it is practiced in community settings (i.e., ecological validity) is essential for translating recent empirically supported approaches to individuals who would benefit most from them. A recent series of federally supported initiatives has focused on enhancing ecological validity by (a) translating findings from federally funded efficacy trials to treatment effectiveness work in real-world settings (particularly with the genesis of the National Drug Abuse Clinical Trials Network) and (b) advancing quantitative methods specifically geared toward addressing the complexities that arise in (and have stifled) treatment research in real-world contexts. The investigation proposed in this R01 application combines work from an ongoing Clinical Trials Network (CTN) effectiveness trial on the most widely used treatment for comorbid substance abuse and PTSD available for women, Seeking Safety, with continuing development, refinement and extension of statistical approaches to handle data from therapy groups when therapy group membership itself changes over time by design. Although progress has been made in developing methods to handle longitudinal data from open-enrollment (also known as "rolling") therapy groups, the most common milieu for treatment delivery in community-based substance abuse programs, several salient critical issues to the stakeholders in substance abuse treatment research remain unresolved and are of primary methodological interest in this investigation. This includes modeling the impact of group membership turnover on (a) the long-term recovery management process, (b) the identification of the active components in ecologically valid treatment trials, and (c) (sub) optimal patient mix in treatment groups and measurement of treatment group (in) stability. The ultimate goal of the proposed secondary data analytic investigation is to place more powerful analytic and methodological tools in the hands of substance abuse and alcoholism treatment researchers for (a) analyzing existing data from open- enrollment groups in a more defensible manner, maximizing the likelihood that incorrect inferences are avoided (i.e., advocating for a treatment that may be ineffective in reality) and that the full complexities of open-enrollment group trials are captured analytically, and/or (b) submitting new applications for trials in all areas of behavioral treatment research with protocols that more closely resemble treatment in community settings. In addition to the practical benefits of the methodological development in this project (e.g., more accurate inferences concerning treatment efficacy, better reflection of the open-enrollment process in data analytic models), this application represents an opportunity for further dissemination, and a more nuanced examination of, what is to date, the largest randomized clinical trial for Seeking Safety. The proposed project seeks to develop more accurate methods to analyze data from open-enrollment substance abuse treatment trials, which present special analytic challenges (i.e., changes in group membership over time). If we are successful in continuing the development and refinement of new modeling tools to address analytic complexities in open-enrollment trials, substance abuse treatment researchers will be positioned to develop federally funded open-enrollment treatment trials that better resemble treatment as it is practiced in community settings. These developments may also facilitate building a "community-friendly" treatment research portfolio for funding agencies that supports substance abuse and alcoholism treatment research.

描述（由申请人提供）：增加治疗研究和治疗之间的联系，因为它是在社区环境中实践（即，生态有效性）对于将最近的经验支持的方法转化为最能从中受益的个人至关重要。最近一系列由联邦政府支持的举措侧重于通过以下方式提高生态有效性：（a）将联邦政府资助的疗效试验的结果转化为现实世界中的治疗效果工作（特别是随着国家药物滥用临床试验网络的诞生）和（B）推进定量方法，特别是针对解决药物滥用临床试验中出现的复杂性。（并扼杀了）现实世界背景下的治疗研究。本R 01申请中提出的研究结合了正在进行的临床试验网络（CTN）有效性试验的工作，该试验是针对可用于女性的最广泛使用的药物滥用和创伤后应激障碍的治疗，寻求安全性，并继续开发，改进和扩展统计方法，以处理治疗组成员资格本身随时间推移而改变时的治疗组数据。虽然已经取得了进展，在开发方法来处理纵向数据从开放注册（也被称为“滚动”）治疗组，最常见的环境，以社区为基础的药物滥用治疗方案，几个突出的关键问题的利益相关者在药物滥用治疗研究仍然没有得到解决，并在本调查的主要方法的兴趣。这包括对组成员更替对（a）长期恢复管理过程，（B）生态有效治疗试验中活性成分的识别，以及（c）治疗组中（次）最佳患者组合和治疗组稳定性测量的影响进行建模。拟议的二级数据分析调查的最终目标是将更强大的分析和方法工具交给药物滥用和酒精中毒治疗研究人员，以便（a）以更合理的方式分析来自开放注册组的现有数据，最大限度地避免不正确推断的可能性（即，提倡一种在现实中可能无效的治疗），并且开放招募组试验的全部复杂性被分析捕获，和/或（B）提交新的申请，以在行为治疗研究的所有领域进行试验，其方案更接近于社区环境中的治疗。除了本项目中方法开发的实际好处之外（例如，关于治疗效果的更准确的推断，在数据分析模型中更好地反映开放式招募过程），该应用程序代表了进一步传播的机会，以及对迄今为止最大的随机临床试验的更细致的检查。拟议的项目旨在开发更准确的方法来分析来自开放式药物滥用治疗试验的数据，这些试验提出了特殊的分析挑战（即，随着时间的推移组成员的变化）。如果我们成功地继续开发和完善新的建模工具，以解决开放式招募试验中的分析复杂性，药物滥用治疗研究人员将能够开发联邦资助的开放式招募治疗试验，更好地模拟社区环境中的治疗。这些发展也可能有助于建立一个“社区友好”的治疗研究组合，为支持药物滥用和酗酒治疗研究的资助机构提供资金。