Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, USA.
Department of Psychology, University of Delaware, USA.
J Affect Disord. 2018 Aug 1;235:368-373. doi: 10.1016/j.jad.2018.04.024. Epub 2018 Apr 4.
As recruitment and retention are often challenging in randomized controlled trials (RCTs), this study sought to identify predictors of participation (i.e., trial enrollment).
These analyses identified predictors of enrollment among 119 youth, ages 7-14, with a primary mood disorder, who screened eligible for the Omega-3 and Therapy pilot studies; 95 (79.8%) actually participated in the treatment.
Youth who received some form of travel assistance (16.0%) almost uniformly enrolled in the treatment portion of the RCT. Youth who lived further away from the study site (p = .047) or whose primary caregiver never married (p = .01) were less likely to enroll. Of note, socioeconomic status (SES) variables (parent education and child insurance status) did not significantly predict enrollment, suggesting that study incentives or accommodations may have adequately addressed barriers commonly associated with SES.
Due to the fairly high trial enrollment rate (approximately 80%), there likely was limited power to detect some differences between groups. Generalizability may be limited to youth with a primary mood disorder diagnosis.
Despite retaining a large proportion of the youth who screened eligible, participant self-selection is a limitation of any RCT. A silent inclusion criterion of any RCT is willingness to be randomized.
由于在随机对照试验（RCT）中招募和保留参与者往往具有挑战性，因此本研究旨在确定参与（即试验入组）的预测因素。
这些分析确定了 119 名年龄在 7-14 岁、患有主要情绪障碍的青少年参与 Omega-3 和治疗试验的预测因素；其中 95 名（79.8%）实际参与了治疗。
接受某种形式旅行援助的青少年（16.0%）几乎全部入组 RCT 的治疗部分。距离研究地点较远的青少年（p=0.047）或其主要照顾者从未结婚的青少年（p=0.01）入组的可能性较低。值得注意的是，社会经济地位（SES）变量（父母教育程度和儿童保险状况）并未显著预测入组，表明研究激励或适应措施可能已充分解决与 SES 相关的常见障碍。
由于试验入组率相当高（约 80%），因此在组间检测某些差异的可能性可能较低。推广可能仅限于主要情绪障碍诊断的青少年。
尽管保留了相当大比例筛选合格的青少年，但参与者的自我选择是任何 RCT 的一个限制因素。任何 RCT 的一个潜在纳入标准是愿意接受随机分组。
