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

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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.