Efficacy of a multicomponent psychological intervention for children with insomnia - randomized con-trolled trial including 3 months follow-up
Clinical Psychiatry, Psychotherapy, Child and Adolescent Psychiatry
Final Report Abstract
The Child Sleep Therapy Study (CSTS) was a project to promote and compare different treatment options for childhood sleep disturbances. The goals of our project were (1) to establish a structured and standardized treatment program (KiSS) for childhood insomnia and (2) to compare our intervention with two control conditions (medical-psychological counselling and waiting list control) in 5 to 10 year old children with insomnia. The study design is a controlled, randomized clinical trial, comparing the KiSS program, to a psychoeducation condition (based on Treatment as usual (PE), which we considered equivalent to placebo treatment and to a control group including the sites Bielefeld and Würzburg. The originally planned PE treatment was not acceptable, because of the personal suffering of those parents that were allocated in the PE group and because of negative outcomes of untreated sleep problems. For this reason, we changed the active control condition, referred to as medical-psychological counselling (MPC) and provided a one hour information about sleep rules (education) and parenting behaviour. We further gave parents the opportunity to tell their specific problems followed by a brief individual counselling. Participants were prior randomized according to a computerised randomization schedule in an equal ratio to receive the KiSS treatment or MPC. A waiting list (WL) control group was not included for economic reasons explained in the Remarks section. Insomnia was defined according to the ICSD-3 criteria. We included objective measures for sleep (actigraphy) and for daytime attention (KiTAP). We also collected subjective measures from parents and children for sleep, daytime attention, and anxiety. Analysis of the entire data set is not yet finished and data will be processed and published in the next months. However, we can already now state that we are faced with a substantial amount of missing actigraphy data as many children refused to wear the actigraph. Altogether a sample of N=190 parents replied to advertisements, N = 82 entered the training (T1), and n=73 were adherent until the end of training (T2). A sample of n=56 (T3) could be assessed 3 months after training. We experienced drop-out rates at all steps, which were not expected on the basis of our previous experience with studies that implemented the KiSS Training vs. Waiting list control. However, two differences occurred in the present study, which can be considered major limitations: Firstly, the active treatment provided was an explanation of sleep rules and short counselling only, and those parents and children were later not provided with the KiSS training, and this was – of course – made explicit to them at the beginning. Thus, parents were not ready to take the risk of being allocated to the active control condition. Further, families did not get any reward for participation nor did we charge any money for participation, which would be paid back to 80% after finalisation of all measurement points. Having said this, we can also state that those parents and children who participated in the KiSS training demonstrated that the treatment is economic and easy to implement in psychiatric care due to the short-term duration and manual based procedure. It is psychosocially relevant as it has the potential to prevent children affected by insomnia from school problems and developing psychiatric disorders.
Publications
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(October 2018). DGSM-Tagung. Medizinisch-psychologische Schlafberatung oder CBT-I bei 5 bis 10-jährigen Kindern mit Insomnie-Ergebnissen der randomisierten kontrollierten Kinderschlaf-Therapiestudie mit 3-Monats Follow-up
Zschoche, M., Schwerdtle, B., Kübler, A., Schlarb A.
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Schlaf Kindlein Schlaf - Therapiekonzepte bei Schlafstörungen. dgkj conference 2018
Schlarb, A., Zschoche, M., Schwerdtle, B., Kübler, A.
