Research staff training in a multisite randomized clinical trial: Methods and recommendations from the Stimulant Reduction Intervention Using Dosed Exercise (STRIDE) trial.

Descriptions of and recommendations for meeting the challenges of training research staff for multisite studies are limited despite the recognized importance of training on trial outcomes. The STRIDE (Stimulant Reduction Intervention using Dosed Exercise) study is a multisite randomized clinical trial that was conducted at nine addiction treatment programs across the United States within the National Drug Abuse Treatment Clinical Trials Network (CTN) and evaluated the addition of exercise to addiction treatment as usual (TAU), compared to health education added to TAU, for individuals with stimulant abuse or dependence. Research staff administered a variety of measures that required a range of interviewing, technical, and clinical skills. To address the absence of information on how research staff are trained for multisite clinical studies, this article describes the conceptual process of training and certifying research assistants for STRIDE. Training was successfully implemented with staff across nine sites. Staff demonstrated evidence of study and procedural knowledge via quizzes and skill demonstration on six measures requiring certification. Overall, while the majority of staff had little to no experience in the six measures, all RAs demonstrated ability to correctly and reliably administer the measures throughout the study.

Conclusions: Overall, the staged training process with competency evaluations for STRIDE was comprehensive, iterative, and ensured all staff conducted study procedures and administered measures reliably. Based on the outcomes of this evaluation, however, the authors recommend several approaches for better training research staff. For example, it is important that trainers not only assess scoring or rating abilities, but assess all skills required to accurately and reliably administered measures in trials. Additionally, trainers should individualize the timeline for re-certifying staff rather than sticking to a predetermined generic timeline. Trainers should also consistently provide feedback in a timely manner and be dedicated solely to the task of training during key study periods.

Related protocols: CTN-0037