Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati OH 45229, USA.
Epilepsy Behav. 2023 Oct;147:109393. doi: 10.1016/j.yebeh.2023.109393. Epub 2023 Aug 22.
A family-tailored education and problem-solving intervention, Supporting Treatment Adherence Regimens (STAR), was developed to address the adherence challenges common in youth with epilepsy and their families. Randomized clinical trial (RCT) results indicated a 21% adherence improvement in the STAR group compared with an education-only (EO) group 12-months post-intervention. The current study examined group differences (STAR vs. EO) in epilepsy-specific knowledge, barriers to medication adherence, problem-solving skills, caregiver emotional distress, and family functioning over time and whether these factors mediated group differences in adherence at 12-months post-intervention.
Two-hundred children (ages 2-12) with epilepsy and their caregivers were included as RCT participants. Children with new-onset epilepsy and adherence <95% were randomized to receive either the STAR (n = 27) or EO (n = 29) intervention. Caregivers completed questionnaires assessing outcomes of interest at baseline, midpoint of the intervention, post-intervention, and 3-, 6-, and 12-month follow-ups. Regression-based analyses of covariance and longitudinal mixed effect linear models were conducted.
Results generally revealed no significant group differences across outcomes of interest at post-intervention or over time. However, one significant model did emerge for social problem-solving skills (b = -1.74, p = 0.04), such that these scores were initially higher in the STAR group compared to the EO group, then decreased slightly in the STAR group over time while remaining stable in the EO group. None of these factors mediated group differences in adherence at 12-months post-intervention.
Future research should examine other potential mechanisms of treatment change after adherence interventions, such as STAR. Nonsignificant findings can inform the development of future study designs and intervention efforts.
为解决青少年癫痫患者及其家庭普遍存在的服药依从性问题,开发了一种针对家庭的教育和问题解决干预措施,即支持治疗依从性方案(STAR)。随机临床试验(RCT)结果表明,与仅接受教育(EO)的对照组相比,STAR 组在干预后 12 个月时的服药依从性提高了 21%。本研究旨在考察 STAR 组与 EO 组在癫痫相关知识、药物依从性障碍、解决问题的能力、照顾者情绪困扰和家庭功能方面的差异,并探讨这些因素是否在干预后 12 个月时对依从性的组间差异有中介作用。
200 名患有癫痫的儿童及其照顾者作为 RCT 参与者被纳入研究。患有新发癫痫且依从性<95%的儿童被随机分为接受 STAR(n=27)或 EO(n=29)干预的两组。照顾者在基线、干预中点、干预后以及 3、6 和 12 个月随访时完成评估感兴趣结局的问卷。采用协方差分析和纵向混合效应线性模型进行回归分析。
结果普遍表明,干预后和随访期间,两组在感兴趣的结局上没有显著差异。然而,有一个模型对于社会问题解决能力(b=-1.74,p=0.04)出现了显著差异,即 STAR 组的这些评分最初高于 EO 组,随后 STAR 组的评分略有下降,而 EO 组的评分则保持稳定。这些因素均未在干预后 12 个月时对依从性的组间差异产生中介作用。
未来的研究应进一步探究其他潜在的治疗改变机制,如 STAR。无显著发现可以为未来的研究设计和干预努力提供信息。