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Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - The SOSTRA trial protocol

机译:注意力缺陷多动障碍儿童的随机社会技能培训和父母培训以及标准治疗与标准治疗的对比-SOSTRA试验方案

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Background Children with attention deficit hyperactivity disorder (ADHD) are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions. Methods/Design The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms. Discussion We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone. Trial registration ClinicalTrials (NCT): NCT00937469
机译:背景技术患有注意力缺陷多动障碍(ADHD)的儿童多动,冲动,无法保持注意力,并且在社交互动方面存在困难。药物治疗可以缓解多动症的症状,但很少能解决社交互动中的困难。社交技能培训可使多动症儿童的社交互动受益。我们想研究社交技能培训对与儿童多动症症状和社交互动有关的困难的影响。方法/设计设计是随机的两组,平行组,评估人盲试验。诊断为多动症的8-12岁儿童被随机分配到社交技能培训和父母培训以及标准治疗与仅标准治疗之间。样本量计算估计,至少要包括52名儿童,才能在干预组和干预组之间的“过度冲动”的Conners 3 rd Edition子量表上显示主要结果的4分差异。控制组。随机分组后3个月和6个月评估结果。主要结果指标是ADHD症状。次要结果是社交技能。三级结局包括社交技能与多动症症状,结依能力和父母多动症症状之间的关系。讨论我们希望该试验的结果将显示,与单独使用药物相比,与药物一起使用的社交技能培训可能对ADHD症状以及社交和情感能力产生更大的一般影响。试验注册临床试验(NCT):NCT00937469

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