BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) is a psychosocially impairing and cost-intensive mental disorder, with first symptoms occurring in early childhood. It can usually be diagnosed reliably at preschool age. Early detection of children with ADHD symptoms and an early, age-appropriate treatment are needed in order to reduce symptoms, prevent secondary problems and enable a better school start. Despite existing ADHD treatment research and guideline recommendations for the treatment of ADHD in preschool children, there is still a need to optimise individualised treatment strategies in order to improve outcomes. Therefore, the ESCApreschool study (Evidence-Based, Stepped Care of ADHD in Preschool Children aged 3 years and 0 months to 6 years and 11 months of age (3;0 to 6;11 years) addresses the treatment of 3-6-year-old preschool children with elevated ADHD symptoms within a large multicentre trial. The study aims to investigate the efficacy of an individualised stepwise-intensifying treatment programme. METHODS The target sample size of ESCApreschool is 200 children (boys and girls) aged 3;0 to 6;11 years with an ADHD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or a diagnosis of oppositional defiant disorder (ODD) plus additional substantial ADHD symptoms. The first step of the adaptive, stepped care design used in ESCApreschool consists of a telephone-assisted self-help (TASH) intervention for parents. Participants are randomised to either the TASH group or a waiting control group. The treatment in step 2 depends on the outcome of step 1: TASH responders without significant residual ADHD/ODD symptoms receive booster sessions of TASH. Partial or non-responders of step 1 are randomised again to either parent management and preschool teacher training or treatment as usual. DISCUSSION The ESCApreschool trial aims to improve knowledge about individualised treatment strategies for preschool children with ADHD following an adaptive stepped care approach, and to provide a scientific basis for individualised medicine for preschool children with ADHD in routine clinical care. TRIAL REGISTRATION The trial was registered at the German Clinical Trials Register (DRKS) as a Current Controlled Trial under DRKS00008971 on 1 October 2015. This manuscript is based on protocol version 3 (14 October 2016).

中文翻译：

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针对注意力缺陷/多动障碍 (ESCApreschool) 的 3-6 岁学龄前儿童的个体化逐步适应性治疗：适应性干预研究的研究方案，包括 ESCAlife 联盟内的两项随机对照试验。

背景注意力缺陷/多动障碍（ADHD）是一种社会心理损害和成本密集型精神障碍，最初症状出现在儿童早期。通常可以在学龄前可靠地诊断出来。需要及早发现患有多动症症状的儿童，并尽早进行适合年龄的治疗，以减轻症状、预防继发问题并实现更好的上学。尽管现有的多动症治疗研究和针对学龄前儿童多动症治疗的指南建议，仍然需要优化个体化治疗策略以改善结果。因此，ESCA学前研究（3岁0个月至6岁11个月（3；0至6；11岁）学龄前儿童ADHD的循证分级护理）解决了3-6岁儿童的治疗问题。 - 在一项大型多中心试验中患有 ADHD 症状加重的学龄前儿童。该研究旨在调查个体化逐步强化治疗方案的有效性。方法 ESCApreschool 的目标样本量是 200 名 3 岁以下的儿童（男孩和女孩）；0 至根据《精神疾病诊断与统计手册》第五版 (DSM-5) 诊断为 ADHD，或诊断为对立违抗性障碍 (ODD) 加上其他严重 ADHD 症状，6;11 岁。适应性、阶梯式护理的第一步ESCApreschool 中使用的设计包括针对家长的电话辅助自助 (TASH) 干预。参与者被随机分配到 TASH 组或等待对照组。步骤 2 中的治疗取决于步骤 1 的结果：TASH 应答者没有严重的 ADHD/ODD 残留症状需要接受 TASH 加强治疗。第 1 步的部分或无反应者再次随机接受家长管理和学前教师培训或照常治疗。讨论 ESCA学前儿童试验旨在提高对学龄前多动症儿童个体化治疗策略的认识，采用适应性阶梯式护理方法，为常规临床护理中学龄前多动症儿童的个体化医疗提供科学依据。试验注册 该试验于 2015 年 10 月 1 日在德国临床试验注册中心 (DRKS) 注册为当前对照试验，编号为 DRKS00008971。本手稿基于方案版本 3（2016 年 10 月 14 日）。