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

基于群体的社交技能训练(SST)已多次被推荐为高功能自闭症谱系障碍(HFASD)的首选治疗方法。到目前为止，还没有进行随机对照试验来确定SST对患有HFASD的儿童和青少年的有效性和安全性。在这项在220名患有HFASD儿童和青少年中进行的随机多中心对照试验中，假设与常规治疗(TAU)相比，使用手册化的“Kontakt”程序添加基于小组的SST将导致社会反应性(通过父母评定的社会反应性量表衡量)的改善。进一步预计，在治疗组中，父母和自我报告的焦虑和抑郁症状将会减少，亲社会行为将会增加。可能调节治疗效果的变量，包括药物和与社会互动相关的基因的常见变异，将被探索。法兰克福HFASD亚组和匹配的健康对照组将在治疗前和治疗后进行神经生理学研究，以评估SST和TAU引起的神经功能变化。这项研究是一项多中心研究，以亚琛、法兰克福、霍姆堡/萨尔堡、科伦、曼海姆和维尔茨堡的大学医院为基础的儿童和青少年精神病学系参与患者招募和治疗。数据管理、生物识别支持和统计分析将在海德堡大学医院的医学生物测量和信息学研究所进行，研究监测由海德堡大学医院临床试验协调中心提供。

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.