Medical Neurosciences, Lilly Research Laboratories Canada, Toronto, ON, Canada.
Child and Adolescent Mental Health Unit, Hospital Universitari Mutua de Terrassa, and Developmental Disorders Unit, Hospital Sant Joan de Déu, Barcelona, Spain.
Neuropsychiatr Dis Treat. 2014 Jun 13;10:1081-92. doi: 10.2147/NDT.S62487. eCollection 2014.
This multicenter, cluster-randomized, nonblinded study evaluated the effect of parental psychoeducation on medication persistence among children and adolescents with newly diagnosed attention-deficit/hyperactivity disorder (ADHD).
Patients received standard medication alone or medication plus a parental psychoeducation program, and were followed for 12 months. The primary endpoint was time to withdrawal or termination of medication due to any cause. Secondary endpoints included change in ADHD symptom severity, functional outcome, program satisfaction, and safety.
A total of 208 patients completed the study, which was terminated early because recruitment had ceased. At 12 months, there was no significant difference between the psychoeducation and control groups in the proportion of patients who discontinued pharmacologic treatment (13.2% versus 14.3%, respectively; size effect -0.3, P=0.34; hazard ratio 0.72, 95% confidence interval 0.36-1.43). Psychoeducation was associated with a significantly greater improvement in ADHD symptoms but not in functional outcome. Parental satisfaction with psychoeducation was high, and satisfaction with pharmacologic treatment was significantly greater in the psychoeducation group. There were no safety concerns.
No significant advantage for parental psychoeducation plus medication over medication alone in terms of time to medication withdrawal was observed. Psychoeducation had inconsistent but interesting effects on other outcomes.
这项多中心、整群随机、非盲研究评估了父母心理教育对新诊断为注意缺陷多动障碍(ADHD)的儿童和青少年药物治疗持续性的影响。
患者接受标准药物治疗或药物联合父母心理教育计划,并随访 12 个月。主要终点是因任何原因停药或终止药物治疗的时间。次要终点包括 ADHD 症状严重程度、功能结局、项目满意度和安全性的变化。
共有 208 名患者完成了这项研究,由于招募工作已经停止,该研究提前结束。在 12 个月时,心理教育组和对照组因药物治疗中断而停药的患者比例无显著差异(分别为 13.2%和 14.3%;大小效应 -0.3,P=0.34;风险比 0.72,95%置信区间 0.36-1.43)。心理教育与 ADHD 症状的显著改善相关,但与功能结局无关。父母对心理教育的满意度很高,心理教育组对药物治疗的满意度显著更高。没有安全性问题。
在药物治疗停药时间方面,父母心理教育加药物治疗并不比单纯药物治疗有显著优势。心理教育对其他结局的影响不一致,但很有趣。