Feasibility of a prospective, longitudinal study of resilience among young military recruits with an embedded laboratory sub-study: the ARMOR pilot trial.
Andrea C Hitz, Michelle Hubbling, Annika Hodges, Emily Hagel Campbell, Ann Bangerter, Melissa A Polusny
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引用次数: 0
Abstract
Background: Despite extensive resilience research with military personnel, progress in developing effective resilience-specific interventions for military service members (MSM) has been limited. To inform the design of effective prevention and intervention strategies, a better understanding of the neurocognitive, behavioral, and social processes associated with resilience is needed. This paper reports on a pilot study testing the feasibility of methods and procedures, to be used in the Advancing Research on Mechanisms of Resilience (ARMOR) longitudinal cohort study. Pilot trial objectives were to evaluate the feasibility of recruitment, retention, and data collection against pre-specified progression criteria for determining whether to proceed with the large-scale study.
Methods: This pilot trial used a pre-test/post-test design with an embedded laboratory sub-study. Participants were young recruits who had recently enlisted in the US Army National Guard and had not yet shipped to Basic Combat Training (BCT). Recruitment and baseline data collection at local armories involved computerized self-report measures and neurocognitive tests. Participants completed a web-based follow-up survey on personal devices after BCT. A subset of participants was recruited to complete laboratory procedures pre- and post-BCT, including clinical interviews and neurobehavioral tasks. To evaluate the feasibility of collecting real-time assessments of military stressors, participants were randomized to receive web-based surveys during BCT.
Results: Among the 105 military service members approached, 101 (96.2%) were recruited. Baseline data collection and retention methods were considered feasible; the response rate to the follow-up survey was over 70%. Recruitment and data collection for the laboratory sub-study were also considered feasible; more than 90% of participants completed follow-up laboratory visits. The collection of web-based surveys during BCT and computerized neurocognitive testing at follow-up was not considered feasible; the large-scale study will remove these components.
Conclusions: Progression to the large-scale trial, with design refinements, was concluded. Lessons learned and recommendations for future research are discussed.
期刊介绍:
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.