Efficacy of a multicomponent psychological intervention for children with insomnia - randomized con-trolled trial including 3 months follow-up

大约15%的学龄前和学龄儿童患有失眠症。症状通常是难以开始和维持睡眠。如果不进行治疗，超过40%的儿童早期睡眠障碍病例会持续存在。睡眠紊乱的后果是白天嗜睡、认知能力受损和学校问题、内化和外化行为以及更高的自杀风险。此外，患成年期抑郁症和焦虑症的风险也会增加。对于5至10岁年龄组，包括儿童及其父母，没有基于手工的心理治疗。因此，我们的团队开发了一种非药物的心理治疗方法，包括认知行为、催眠治疗和教育成分（KiSS）。在一项试点研究中，该治疗方案导致治疗组的睡眠问题明显多于等候名单对照组（Schlarb et al., 2011）。基于这些初步结果，我们现在申请一项随机、对照、大型结果研究，并假设在失眠症儿童（5-10岁）中，这种治疗方法在减少睡眠问题方面优于心理教育（PE）和等候名单对照组（WL）。作为主要结果测量，我们期望通过活动描记术测量睡眠发作潜伏期减少。作为次要结局指标，我们进一步预测治疗组夜间醒来次数减少，夜间恐惧和睡前挣扎减少，缓解率（短期和长期）更高，白天嗜睡减少，注意力水平更高。此外，我们预测父母的睡眠、心理健康和抑郁症状的显著改善，特别是对母亲来说。

Approximately 15% of preschool and school children are affected by insomnia. Symptoms are usually difficulties initiating and maintaining sleep. Without treatment, sleep disturbances in early childhood persist in more than 40% of the cases. Consequences of disturbed sleep are daytime sleepiness, im-paired cognitive performance and school problems, internalizing and externalizing behaviour and a higher risk for suicide. Furthermore, the risk increases for adulthood depression and anxiety disorders. For the age group of 5 to 10 years, no manual based psychological treatment, including children and their parents, is available. Therefore, our group developed a non-pharmacological, psychological treatment with cognitive-behavioural, hypnotherapeutic and educational components (KiSS). In a pilot-study this treatment program led to a significantly larger reduction of sleep problems in the treatment group than in the waiting list control group (Schlarb et al., 2011). Based on these preliminary results we now apply for a randomized, controlled, large outcome study and assume that in children (aged 5-10 years) with insomnia the treatment will be superior in reducing sleep problems to psychoeducation (PE) and a waiting list control group (WL). As primary outcome measure, we expect reduced sleep onset latency as measured with actigraphy. As secondary outcome measures we further predict for the treatment group reduced number of night-time awakenings, less night-time fears and bedtime struggles, higher remission rates (short- and long-term), less daytime sleepiness and higher level of attention. Additionally, we predict a significant improvement of parental sleep, psychological wellbeing and a reduction of depressive symptoms, specifically for mothers.