Innovative Analyses of Alcohol Intervention Trials for College Students

描述（由申请人提供）：本申请人发起的R 01申请（PA-07-070）提出了对从20项独立干预试验研究中汇总的现有原始数据（基线时N = 20，595）进行综合数据分析（IDA），以克服单项研究的缺点，并产生新的知识体系，以超越疗效。在以个人为导向的干预措施中，以减少大学校园中的大量饮酒，有证据表明，将联合收割机简短的认知行为技能与规范澄清和动机增强相结合的干预措施，简短的动机增强干预措施和酒精预期挑战是有效的。然而，这些干预措施如何发挥作用，哪些因素可能改变其有效性，以及哪些次要结果可能受到影响等关键问题仍然没有答案。这种缺乏明确理解的情况受到个体临床试验研究的概念和设计局限性的阻碍，包括相对同质的样本、相对较小的样本量、有限的统计功效、对潜在变化机制结构的有限心理测量评估以及在观察频率和持续时间方面的有限评估。本申请提出通过将数据汇集在一起并直接分析它们作为单个数据集来解决单个研究的这些局限性，该单个数据集利用心理测量学、纵向数据分析和干预评估方法学的最新进展。这项申请追求四个具体目标：（1）根据来自不同研究的数据制定一套更严格的衡量标准，以确保每项衡量标准都有一个共同的基本指标，使用修改后的项目反应理论模型，（2）评估酒精和药物使用的干预后轨迹是否以及何时发生明显的转变，以及个体和情境差异是否有助于干预后的不同轨迹，（3）测试变化的独特机制（例如，酒精预期的变化、保护策略、改变的准备、同伴规范）并检查潜在的调节者（例如，酒精中毒家族史、性别）促进或阻碍干预后的变化;（4）检验酒精干预对药物使用和其他次要结局的疗效。拟议的研究有可能通过对大学生酒精干预研究领域，更广泛地说，临床治疗研究和定量方法学领域做出独特的贡献，产生重大影响。 公共卫生相关性：这项研究的结果将产生很大的影响，为预防设计者和政策制定者提供重要信息，以指导改善大学生的酒精干预措施。改进的干预措施将减少与大量饮酒相关的众多问题，并改善大学生及其互动者的生活。这些干预措施也有可能用于其他人群，如未上大学的新兴成年人和青少年。

DESCRIPTION (provided by applicant): This investigator-initiated R01 application (PA-07-070) proposes integrative data analysis (IDA) of existing raw data (N = 20,595 at baseline) pooled from 20 independent intervention trial studies to overcome shortcomings of individual studies and to generate a new body of knowledge to move beyond efficacy. Among individually- oriented interventions to reduce heavy drinking on college campuses, there is evidence that interventions that combine brief cognitive-behavioral skills with norms clarification and motivational enhancement, brief motivational enhancement interventions, and alcohol expectancy challenges are efficacious. However, critical questions remain unanswered with respect to how these interventions work, what may modify their effectiveness, and what secondary outcomes may be affected. This lack of clear understanding has been hampered by conceptual and design limitations of individual clinical trial studies, including relatively homogeneous samples, relatively small sample sizes, limited statistical power, limited psychometric assessment of constructs of potential mechanisms of change, and limited assessments in terms of frequency and duration under observation. The present application proposes to address these limitations of single studies by pooling data together and directly analyzing them as a single data set drawing on recent advances in psychometrics, longitudinal data analysis, and intervention evaluation methodology. This application pursues four specific aims: (1) to develop a more rigorous set of measures based on data from different studies to ensure that each measure shares a common underlying metric using a modified item response theory model, (2) to evaluate whether and when distinctive transitions in post-intervention trajectories of alcohol and drug use occur over time, and whether individual and situational differences contribute to different trajectories post- intervention, (3) to test distinctive mechanisms of change (e.g., changes in alcohol expectancies, protective strategies, readiness to change, peer norms) and to examine whether potential moderators (e.g., family history of alcoholism, gender) either facilitate or hinder post-intervention changes, and (4) to test the efficacy of alcohol interventions for drug use and other secondary outcomes. The proposed study has the potential for having a significant impact by making unique contributions to the field of alcohol intervention research for college students and, more broadly, to clinical treatment research and to the field of quantitative methodology. PUBLIC HEALTH RELEVANCE: The results of this study will have a large impact by providing important information to prevention designers and policy makers to guide improvements in alcohol interventions for college students. Improved interventions will reduce the multitude of problems associated with heavy drinking and enhance the lives of college students and those with whom they interact. These interventions will also have the potential to be used with other populations, such as emerging adults who do not go to college and younger adolescents.