Innovative Analyses of Alcohol Intervention Trials for College Students

描述（由申请人提供）：这项研究者发起的R01申请（PA-07-070）提出了对现有的原始数据（基线时N = 20,595）进行综合数据分析（IDA），这些数据来自20项独立干预试验研究，以克服单个研究的缺点，并产生新的知识体系，超越疗效。在以个人为导向的减少大学校园酗酒的干预措施中，有证据表明，结合规范澄清和动机增强的简短认知行为技能、简短动机增强干预和酒精预期挑战的干预措施是有效的。然而，这些干预措施是如何起作用的，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，这些关键问题仍未得到解答。个体临床试验研究的概念和设计局限性阻碍了这种缺乏清晰认识的研究，包括相对均匀的样本、相对较小的样本量、有限的统计能力、有限的潜在变化机制构建的心理测量评估，以及在观察频率和持续时间方面的有限评估。本申请建议通过汇集数据并利用心理测量学、纵向数据分析和干预评估方法的最新进展将它们作为单一数据集直接分析来解决这些单一研究的局限性。该应用程序追求四个具体目标：(1)根据不同研究的数据制定一套更严格的措施，以确保每项措施使用改进的项目反应理论模型共享一个共同的基本指标；(2)评估干预后酒精和药物使用轨迹的不同转变是否以及何时随时间发生，以及个体和情境差异是否会导致干预后不同的轨迹；(3)测试不同的变化机制(例如，酒精预期的变化、保护策略、改变的准备程度、同伴规范)，并检查潜在的调节因素（如酗酒家族史、性别）是否促进或阻碍干预后的变化，以及(4)测试酒精干预对吸毒和其他次要结果的有效性。拟议的研究有可能产生重大影响，对大学生酒精干预研究领域做出独特贡献，更广泛地说，对临床治疗研究和定量方法领域做出独特贡献。

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.