Chronis-Tuscano Andrea, Seymour Karen E, Stein Mark A, Jones Heather A, Jiles Cynthia D, Rooney Mary E, Conlon Charles J, Efron Lisa A, Wagner Stephanie A, Pian Jessica, Robb Adelaide S
University of Maryland, Department of Psychology, College Park, MD 20742, USA.
J Clin Psychiatry. 2008 Dec;69(12):1938-47. doi: 10.4088/jcp.v69n1213. Epub 2008 Dec 2.
A preliminary study to examine the efficacy of osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) symptoms and parenting behaviors in mothers with ADHD who had children with ADHD.
Participants included 23 mother-child dyads in which both were diagnosed with DSM-IV ADHD. Mothers underwent a 5-week, double-blind titration (placebo, 36 mg/day, 54 mg/day, 72 mg/day, 90 mg/day) to an optimal dose of OROS methylphenidate, followed by random assignment to 2 weeks of placebo or their maximally effective dose. Primary outcome measures included maternal ADHD symptoms (Conners' Adult ADHD Rating Scale) and parenting (Alabama Parenting Questionnaire). Secondary outcomes included side effects ratings. Data were collected from December 2004 until August 2006.
During Phase 1, mothers reported significant decreases in inattention (p < .001) and hyperactivity/impulsivity (p < .01) with increases in OROS methylphenidate dose. As dose increased, significant reductions in inconsistent discipline (p < .01) and corporal punishment use (p < .005) were also demonstrated. During Phase 2, small effects on inattention (d = 0.46) and hyperactivity/impulsivity (d = 0.38) were found for those randomly assigned to medication versus placebo. In addition, medium to large medication effects were found on maternal involvement (d = 0.52), poor monitoring/supervision (d = 0.70), and inconsistent discipline (d = 0.71), with small effects on corporal punishment (d = 0.42). During both phases, few adverse effects were noted.
OROS methylphenidate was well tolerated and was associated with significant improvement in maternal ADHD symptoms and parenting. Variable effects on parenting suggest that behavioral interventions may be necessary to address impairments in parenting among adults with ADHD.
clinicaltrials.gov Identifier: NCT00318981.
进行一项初步研究,以检验渗透泵控释口服系统(OROS)哌甲酯对患有注意力缺陷多动障碍(ADHD)的母亲及其患有ADHD的孩子的ADHD症状和养育行为的疗效。
研究对象包括23对母婴,二者均被诊断为符合《精神疾病诊断与统计手册》第四版(DSM-IV)标准的ADHD。母亲们接受为期5周的双盲滴定(安慰剂、36毫克/天、54毫克/天、72毫克/天、90毫克/天),以确定OROS哌甲酯的最佳剂量,随后随机分配接受2周的安慰剂或其最大有效剂量治疗。主要结局指标包括母亲的ADHD症状(康纳斯成人ADHD评定量表)和养育行为(阿拉巴马养育问卷)。次要结局指标包括副作用评分。数据收集时间为2004年12月至2006年8月。
在第一阶段,母亲们报告随着OROS哌甲酯剂量增加,注意力不集中(p <.001)和多动/冲动(p <.01)症状显著减轻。随着剂量增加,不一致的管教方式(p <.01)和体罚的使用(p <.005)也显著减少。在第二阶段,随机分配接受药物治疗与安慰剂治疗的母亲相比,在注意力不集中(d = 0.46)和多动/冲动(d = 0.38)方面发现了较小的效应。此外,在母亲参与度(d = 0.52)、监督不力/监管缺失(d = 0.70)和管教方式不一致(d = 0.71)方面发现了中等至较大的药物效应,在体罚方面发现了较小的效应(d = 0.42)。在两个阶段中,均未观察到明显的不良反应。
OROS哌甲酯耐受性良好,与母亲ADHD症状和养育行为的显著改善相关。养育行为方面的不同效应表明,可能需要行为干预来解决患有ADHD的成年人在养育子女方面的缺陷。
美国国立医学图书馆临床试验注册中心标识符:NCT00318981。