Controlled-release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in children with autism spectrum disorders: a randomized placebo-controlled trial
Controlled-release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in children with autism spectrum disorders: a randomized placebo-controlled trial
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DOI：
10.1111/j.1365-2869.2012.01021.x
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发表时间：
2012-12-01
影响因子：
4.4
通讯作者：
Valente, Donatella
中科院分区：
文献类型：
--
作者：
Cortesi, Flavia;Giannotti, Flavia;Valente, Donatella
虽然褪黑激素和认知行为疗法在治疗自闭症谱系障碍儿童的睡眠障碍方面显示出有效性，但对它们的相对或联合疗效知之甚少。160名患有自闭症谱系障碍的儿童，年龄410岁，患有睡眠发作性失眠和睡眠维持受损，被随机分配到（1）控释褪黑激素和认知行为治疗的组合;（2）控释褪黑激素;（3）四次认知行为治疗;或（4）安慰剂药物治疗条件，在1：一曰：一曰：1比率。在基线和治疗12周后对儿童进行研究。通过1周活动监测、睡眠日记和睡眠问卷评估治疗反应。主要的结果指标是睡眠潜伏期、总睡眠时间、入睡后醒来和醒来次数。活性药物治疗组的所有结局指标均得到改善，从基线至12周评估的效应量为中到大。褪黑激素治疗主要有效地减少失眠症状，而认知行为疗法主要对睡眠潜伏期有轻微的积极影响，这表明某些行为方面可能在确定初始失眠中发挥作用。联合治疗组表现出优于其他活性治疗组的趋势，脱落率更低，治疗应答者中实现临床显著变化的比例更高（63.38%，标准睡眠效率标准>85%和84.62%，睡眠起始潜伏期> 85%）。
Although melatonin and cognitivebehavioural therapy have shown efficacy in treating sleep disorders in children with autism spectrum disorders, little is known about their relative or combined efficacy. One hundred and sixty children with autism spectrum disorders, aged 410 years, suffering from sleep onset insomnia and impaired sleep maintenance, were assigned randomly to either (1) combination of controlled-release melatonin and cognitivebehavioural therapy; (2) controlled-release melatonin; (3) four sessions of cognitivebehavioural therapy; or (4) placebo drug treatment condition for 12 weeks in a 1 : 1 : 1 : 1 ratio. Children were studied at baseline and after 12 weeks of treatment. Treatment response was assessed with 1-week actigraphic monitoring, sleep diary and sleep questionnaire. Main outcome measures, derived actigraphically, were sleep latency, total sleep time, wake after sleep onset and number of awakenings. The active treatment groups all resulted in improvements across all outcome measures, with moderate-to-large effect sizes from baseline to a 12-week assessment. Melatonin treatment was mainly effective in reducing insomnia symptoms, while cognitivebehavioural therapy had a light positive impact mainly on sleep latency, suggesting that some behavioural aspects might play a role in determining initial insomnia. The combination treatment group showed a trend to outperform other active treatment groups, with fewer dropouts and a greater proportion of treatment responders achieving clinically significant changes (63.38% normative sleep efficiency criterion of >85% and 84.62%, sleep onset latency