Child and Adolescent Mental Health Services Southern Jutland, Kresten Phillipsens Vej 15, Aabenraa, Region of Southern Denmark, Denmark.
Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Winsløwparken 19, 3, Odense C, Denmark.
Trials. 2021 Oct 29;22(1):752. doi: 10.1186/s13063-021-05499-9.
Problems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poor organizational skills that are important in relation to school. These problems tend to increase from childhood to adolescence and are often not well managed by medication. Organizational skills training (OST) is a range of behavioral interventions that specifically target organizational skills deficits. Evidence supports the effect of OST on improving organizational skills, inattention, and academic performance in children with ADHD. Because previous clinical trials included mostly children above the age of 8 years, this trial includes children in the age range 6-13 years to expand the knowledge on the effects of OST in younger children. Previous OST research has also shown improvement on inattention in parent ratings; we will investigate if a change in inattention can be confirmed with neurocognitive tests. Finally, little is known about predictors of treatment response in OST.
The primary objective is to investigate if OST has positive effects on organizational skills in children with ADHD. The primary outcome measurement is the parent-rated Children's Organizational Skills Scale (COSS), collected before and at the end of the 10 week intervention. Secondary and exploratory outcomes include inattention ratings, family and school functioning, and cognitive functions measured before the intervention period, immediately after, and at a 6 month follow-up. Additional objectives are to investigate both neurocognitive outcomes and age as predictors of treatment response.
This is a randomized clinical superiority trial investigating the effect of OST vs a treatment-as-usual (TAU) control group for children with ADHD in the age range of 6-13 years. All participants (n = 142) receive TAU. OST is administered in a group format of 10 weekly sessions. Adverse events are monitored by study clinicians during weekly therapy sessions and all assessments. Data analyses will be conducted using mixed linear regression models with random intercepts for patients, adjusted for the stratification variables and the baseline value.
This study will provide important new knowledge and expand on existing research in the field of non-pharmacological treatment of children with ADHD. OST can potentially have a significant impact on the lives of children with ADHD by helping them learn how to cope with their present deficits and to become more independent and self-reliant. It is also important to investigate predictors of treatment response in order to optimize OST.
ClinicalTrials.gov NCT03160378 . Registered on May 19, 2017.
注意力缺陷多动障碍（ADHD）最突出的症状是持续性注意力、冲动和多动问题，但许多患有该疾病的儿童还存在组织技能较差的问题，这对学校来说很重要。这些问题往往会从儿童期持续到青春期，并且药物治疗通常效果不佳。组织技能训练（OST）是一系列专门针对组织技能缺陷的行为干预措施。有证据表明，OST 可以改善 ADHD 儿童的组织技能、注意力不集中和学业成绩。由于之前的临床试验大多包括 8 岁以上的儿童，因此本试验纳入了 6-13 岁的儿童，以扩大 OST 在年龄较小的儿童中的效果知识。之前的 OST 研究也表明，在父母评估中注意力不集中得到改善；我们将调查在神经认知测试中是否可以确认注意力不集中的变化。最后，OST 中治疗反应的预测因素知之甚少。
本研究旨在探讨 OST 是否对 ADHD 儿童的组织技能有积极影响。主要结局测量是父母评定的儿童组织技能量表（COSS），在 10 周干预前后进行收集。次要和探索性结局包括注意力不集中评定、家庭和学校功能以及在干预前、干预后立即和 6 个月随访时的认知功能。其他目的是研究神经认知结果和年龄作为治疗反应的预测因素。
这是一项随机临床优效性试验，研究 OST 对 6-13 岁 ADHD 儿童的效果，与治疗常规（TAU）对照组进行比较。所有参与者（n=142）均接受 TAU。OST 以每周 10 次小组形式进行。研究临床医生在每周的治疗期间和所有评估时监测不良事件。数据分析将使用混合线性回归模型进行，模型的患者随机截距进行调整，以适应分层变量和基线值。
本研究将提供关于 ADHD 儿童非药物治疗领域的重要新知识，并扩展现有研究。OST 通过帮助儿童学习如何应对当前的缺陷，以及变得更加独立和自力更生，有可能对 ADHD 儿童的生活产生重大影响。此外，研究治疗反应的预测因素对于优化 OST 也很重要。
ClinicalTrials.gov NCT03160378。于 2017 年 5 月 19 日注册。
