Innovative Analyses of Alcohol Intervention Trials for College Students

描述(由申请人提供)：这项由研究人员发起的R01申请(PA-07-070)建议对来自20项独立干预试验研究的现有原始数据(基线N=20,595)进行综合数据分析(IDA)，以克服个别研究的缺点，并产生超越有效性的新知识体系。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、简短的动机增强干预和酒精预期挑战相结合的干预措施是有效的。然而，关于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未得到回答。由于个别临床试验研究的概念和设计上的局限性，包括相对同质的样本、相对较小的样本量、有限的统计能力、对潜在变化机制的结构进行有限的心理测量评估，以及在观察的频率和持续时间方面的有限评估，这种缺乏清晰的理解受到了阻碍。本申请建议利用心理测量学、纵向数据分析和干预评估方法的最新进展，通过将数据汇集在一起并将其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)基于来自不同研究的数据开发一组更严格的测量，以使用改进的项目反应理论模型确保每个测量共享共同的潜在测量，(2)评估干预后酒精和药物使用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(例如，酗酒家族史，(4)测试酒精干预对药物使用和其他次要结果的有效性。这项拟议的研究可能会对大学生酒精干预研究领域以及更广泛地说，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.