Randomized multi-centre controlled trial of group-based social skills training in children and adolescents with high functioning Autism Spectrum Disorder (SOSTA-Net)

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Group based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no randomized controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised multi-centre controlled trial in 220 children and adolescents with HFASD it is hypothesized, that add-ön group-based SST using the manualised "KONTAKT" program will result in improved social responsiveness (measured by the parent rated social responsiveness scale) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive Symptoms will decline and pro-social behaviour will increase in the treatment group. Variables possibly mediating treatment effect, including medication and common variants in genes related to social interaction, will be explored. A neurophysiological study in the Frankfurt HFASD subgroup and a matched healthy control group will be performed pre- and post treatment to assess changes in neuronal function induced by SST versus TAU. The study is a multi-centre study with the University Hospital based Departments of Child and Adolescent Psychiatry at Aachen, Frankfurt, Homburg/Saar, Köln, Mannheim, and Würzburg participating in patient recruitment and treatment. Data management, biometrical support and statistical analyses will be performed at the Institute of Medical Biometry and Informatics, University Hospital Heidelberg, and study monitoring is provided by the Coordination Centre for Clinical Trials, University Hospital Heidelberg.