Department of Psychology, University of Rhode Island, Kingston, RI, USA.
Clin Trials. 2011 Apr;8(2):205-13. doi: 10.1177/1740774510396387. Epub 2011 Jan 26.
Matriculation from high school to college is typified by an increase in alcohol use and related harm for many students. Therefore, this transition period is an ideal time for preventive interventions to target alcohol use and related problems.
The purpose of this report is to describe the design and methods used in the Transitions Project, a randomized controlled trial of two interventions designed to prevent and reduce heavy episodic drinking and alcohol-related negative consequences among incoming college students.
This study used a 2 × 2 factorial design to investigate the effects of a two-session brief motivational intervention delivered to students and a handbook-based parent intervention. Interventions were administered to students and parents. Follow-up assessment took place at 10- and 22-months post-baseline.
The Transitions Project successfully recruited and retained participants across a major transition period (i.e., entering college), administered and compared two distinct but complementary interventions, and collected and analyzed highly skewed data. The application of a factorial design and two-part latent growth curve modeling allowed us to examine main and interactive intervention effects in terms of both initiation and growth in heavy drinking and alcohol-related problems.
While we conducted successful tests of our primary and secondary study hypotheses over a lengthy follow-up period, our study design did not permit full interpretation of null findings. We suggest that researchers carefully consider assessment timing, tests of assessment reactivity, and ensure objective tests of intervention efficacy when conducting clinical trials of motivational interventions.
The lessons we learned while conducting this trial have the potential to assist other researchers designing and conducting future preventive interventions targeting parents and college students. The data analytic procedures presented can also help guide trials that plan to analyze zero-inflated non-normal outcome data.
从高中到大学的升学阶段，许多学生的饮酒量增加，相关危害也随之增加。因此，这个过渡时期是针对饮酒和相关问题进行预防干预的理想时机。
本报告旨在描述“过渡项目”的设计和方法，该项目是一项针对即将进入大学的学生的随机对照试验，旨在预防和减少重度饮酒和与酒精相关的负面后果。
本研究采用 2×2 析因设计，调查了两部分干预措施的效果，这两部分干预措施分别是向学生提供两节课的简短动机干预和基于手册的家长干预。干预措施分发给学生和家长。在基线后 10 个月和 22 个月进行随访评估。
“过渡项目”成功地在一个重大过渡时期（即进入大学）招募并保留了参与者，实施并比较了两种不同但互补的干预措施，并收集和分析了高度偏态数据。析因设计和两部分潜在增长曲线模型的应用使我们能够根据重度饮酒和与酒精相关问题的开始和增长来检验主要和交互干预效果。
虽然我们在长时间的随访中成功地检验了我们的主要和次要研究假设，但我们的研究设计并没有完全解释无效结果。我们建议研究人员在进行动机干预的临床试验时，仔细考虑评估时间、评估反应性测试，并确保对干预效果进行客观测试。
我们在进行这项试验时所学到的经验教训有可能帮助其他研究人员设计和进行针对家长和大学生的未来预防干预。所提出的数据分析程序也可以帮助指导计划分析零膨胀非正态结果数据的试验。
