Innovative Analyses of Alcohol Intervention Trials for College Students

描述（由申请人提供）：这项由研究者发起的 R01 申请 (PA-07-070) 提议对来自 20 项独立干预试验研究的现有原始数据（基线时 N = 20,595）进行综合数据分析 (IDA)，以克服个别研究的缺点并生成新的知识体系以超越功效。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，将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，关于这些干预措施如何发挥作用、什么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未得到解答。这种缺乏清晰理解的情况受到个别临床试验研究的概念和设计限制的阻碍，包括相对同质的样本、相对较小的样本量、有限的统计功效、对潜在变化机制的构建的心理测量评估有限，以及对观察频率和持续时间的评估有限。本申请提出通过将数据汇集在一起​​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直接分析为单个数据集来解决单个研究的这些局限性。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衡量标准，以确保每个衡量标准使用修改后的项目反应理论模型共享一个共同的基础指标，（2）评估干预后酒精和药物使用轨迹是否以及何时随着时间的推移发生独特的转变，以及个体和情境差异是否会导致干预后的不同轨迹，（3）测试独特的变化机制（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（例如酗酒家族史、性别）是否促进或阻碍干预后的变化，以及（4）测试酒精干预措施对吸毒和其他次要结果的有效性。拟议的研究有可能对大学生酒精干预研究领域，更广泛地说，对临床治疗研究和定量方法学领域做出独特的贡献，从而产生重大影响。

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.