The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial
The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial
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DOI：
10.1186/1745-6215-14-6
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发表时间：
2013-01-07
期刊：
影响因子：
2.5
通讯作者：
Kieser, Meinhard
中科院分区：
文献类型：
--
作者：
Freitag, Christine M.;Cholemkery, Hannah;Kieser, Meinhard
背景：基于群体的社交技能训练(SST)已多次被推荐为治疗高功能自闭症谱系障碍(HFASD)的首选方法。到目前为止，还没有进行足够有效的随机对照试验来确定SST在患有HFASD的儿童和青少年中的有效性和安全性。在这项对220名患有HFASD儿童和青少年的随机、多中心、对照试验中，假设使用12周的SOSTA-FRA计划的基于附加小组的SST将导致与通常治疗(TAU)相比，社会反应性(通过父母评定的社会反应性量表(SRS)来衡量)得到改善。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。法兰克福HFASD亚组的一项神经生理学研究将在治疗前和治疗后进行，以评估SST和TAU引起的神经功能变化。方法/设计：SOSTA-Net试验是一项前瞻性、随机、多中心、对照试验，有两个平行小组。主要结果是干预后即刻和3个月随访时SRS评分的变化。还得到了几个次要结果指标。目标样本包括六个研究中心的220名ASD患者。讨论：这项研究是目前世界上最大的关于HFASD儿童和青少年SST的试验之一。与最近的随机对照研究相比，我们的研究在纳入和排除标准、研究方法和选择的治疗方法方面显示出几个优势，这些优势可以很容易地在非大学临床环境中实施。
Background: Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised 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 with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA-FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) 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. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU.Methods/design: The SOSTA - net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres.Discussion: This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings.