Conduct disorder (CD) is a complex mental disorder characterized by severe rule-breaking and aggressive behavior. While studies have shown that several therapeutic interventions are effective in treating CD symptoms, researchers call for treatments based on etiological knowledge and potential patho-mechanisms. Mentalization-based treatment (MBT) may represent such a treatment approach: Studies have shown that individuals with CD show mentalizing deficits and that mentalizing might represent a protective factor against the development of the disorder. As MBT focuses on the understanding of social behavior in terms of mental states, fostering mentalizing might help CD individuals to (re)gain an adaptive way of coping with negative emotions especially in social interactions and thus reduce aggressive behavior. For this purpose, MBT was adapted for adolescents with CD (MBT-CD). This is a protocol of a feasibility and pilot study to inform the planning of a prospective RCT. The primary aim is to estimate the feasibility of an RCT based on the acceptability of the intervention and the scientific assessments by CD individuals and their families indicated by quantitative and qualitative data, as well as based on necessary organizational resources to conduct an RCT. The secondary aim is to investigate the course of symptom severity and mentalizing skills. The bi-center study is carried out in two outpatient settings associated with university hospitals (Heidelberg and Mainz) in Germany. Adolescents aged between 11 and 18 years with a CD or oppositional defiant disorder (ODD) diagnosis are included. Participants receive MBT-CD for 6 to 12 months. The primary outcome of the feasibility study (e.g., recruitment and adherence rates) will be descriptively analyzed. Multilevel modeling will be used to investigate secondary outcome data. Fostering the capacity to mentalize social interactions triggering non-mentalized, aggressive behavior might help CD individuals to behave more adaptively. The feasibility trial is essential for gathering information on how to properly conduct MBT-CD including appropriate scientific assessments in this patient group, in order to subsequently investigate the effectiveness of MBT-CD in an RCT. ClinicalTrials.gov , NCT02988453 . November 30, 2016 Dietmar Hopp Stiftung, Heidehof Stiftung Recruitment complete and intervention complete, follow-up assessments ongoing (Heidelberg). Recruitment and assessments ongoing (Mainz). Svenja Taubner is responsible for the design and conduct of MBT-CD intervention and feasibility and pilot study, preparation of protocol and revisions, and publication of study results. Esther Sobanski is responsible for the recruitment and data collection in the collaborating center Mainz Germany Conduct disorder, oppositional defiant disorder Mentalization-based treatment for conduct disorder (MBT-CD): MBT-CD is an adaptation of MBT for Borderline Personality Disorder. This manualized psychodynamic psychotherapy focuses on increasing mentalizing, i.e., the ability to understand behavior in terms of mental states, in patients. MBT-CD includes weekly individual sessions with the patient and monthly family sessions. Included are adolescent individuals with a diagnosis of conduct disorder or oppositional defiant disorder aged between 11 and 18 years. Feasibility and pilot study (single-group) 19.01.2017 The trial is currently in the follow-up assessment phase in Heidelberg and in the recruitment and treatment phase in Mainz. Acceptability of MBT-CD intervention (as indicated by recruitment rates, completion rates, drop-out rates, treatment duration, oral evaluation), acceptability of scientific assessments (as indicated by adherence, missing data, oral evaluation), and necessary organizational resources (scientific personnel, recruitment networks, MBT-CD training and supervision) to estimate feasibility of an RCT Adolescents’ symptom severity and mentalizing ability 20.08.2020, version 1.0

中文翻译：

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行为障碍青少年心理化治疗 (MBT-CD)：可行性和试点研究方案

品行障碍（CD）是一种复杂的精神障碍，其特征是严重的违反规则和攻击性行为。虽然研究表明几种治疗干预措施可有效治疗 CD 症状，但研究人员呼吁根据病因学知识和潜在的病理机制进行治疗。基于心智化的治疗 (MBT) 可能代表了这样一种治疗方法：研究表明，患有 CD 的个体表现出心智化缺陷，而心智化可能是一种防止疾病发展的保护因素。由于 MBT 侧重于从心理状态的角度理解社会行为，因此培养心理化可能有助于 CD 个体（重新）获得应对负面情绪的适应性方式，尤其是在社交互动中，从而减少攻击性行为。以此目的，MBT 适用于患有 CD 的青少年 (MBT-CD)。这是一项可行性和试点研究方案，旨在为前瞻性 RCT 的规划提供信息。主要目的是根据干预的可接受性和 CD 个人及其家人通过定量和定性数据表明的科学评估，以及基于进行 RCT 的必要组织资源来估计 RCT 的可行性。次要目的是调查症状严重程度和心理化技能的过程。这项双中心研究在与德国大学医院（海德堡和美因茨）相关的两个门诊环境中进行。包括诊断为 CD 或对立违抗障碍 (ODD) 的 11 至 18 岁的青少年。参与者接受 MBT-CD 6 至 12 个月。可行性研究的主要结果（例如，招募和依从率）将进行描述性分析。多级建模将用于研究次要结果数据。培养引发非心理化、攻击性行为的社交互动的心理化能力可能有助于 CD 个体的行为更具适应性。可行性试验对于收集有关如何正确实施 MBT-CD 的信息（包括在该患者组中进行适当的科学评估）至关重要，以便随后调查 MBT-CD 在 RCT 中的有效性。ClinicalTrials.gov，NCT02988453。2016 年 11 月 30 日 Dietmar Hopp Stiftung, Heidehof Stiftung 招募完成和干预完成，后续评估正在进行中（海德堡）。正在进行招聘和评估（美因茨）。Svenja Taubner 负责 MBT-CD 干预、可行性和试点研究的设计和实施、方案的准备和修订以及研究结果的发布。Esther Sobanski 负责德国美因茨合作中心的招募和数据收集 品行障碍、对立违抗障碍 基于心理化的品行障碍治疗 (MBT-CD)：MBT-CD 是 MBT 对边缘性人格障碍的改编。这种手动化的心理动力学心理治疗侧重于提高心理化，即在患者的心理状态下理解行为的能力。MBT-CD 包括每周与患者的个人会议和每月的家庭会议。包括被诊断为行为障碍或对立违抗障碍的 11 至 18 岁的青少年个体。可行性和试点研究（单组） 19.01.2017 该试验目前在海德堡处于后续评估阶段，在美因茨处于招募和​​治疗阶段。MBT-CD 干预的可接受性（如招募率、完成率、退出率、治疗持续时间、口头评估所示）、科学评估的可接受性（如依从性、缺失数据、口头评估所示）和必要的组织资源（科学人员、招聘网络、MBT-CD 培训和监督）评估 RCT 青少年症状严重程度和心智化能力的可行性 20.08.2020，1.0 版 2017 该试验目前在海德堡处于后续评估阶段，在美因茨处于招募和​​治疗阶段。MBT-CD 干预的可接受性（如招募率、完成率、退出率、治疗持续时间、口头评估所示）、科学评估的可接受性（如依从性、缺失数据、口头评估所示）和必要的组织资源（科学人员、招聘网络、MBT-CD 培训和监督）评估 RCT 青少年症状严重程度和心智化能力的可行性 20.08.2020，1.0 版 2017 该试验目前在海德堡处于后续评估阶段，在美因茨处于招募和​​治疗阶段。MBT-CD 干预的可接受性（如招募率、完成率、退出率、治疗持续时间、口头评估所示）、科学评估的可接受性（如依从性、缺失数据、口头评估所示）和必要的组织资源（科学人员、招聘网络、MBT-CD 培训和监督）评估 RCT 青少年症状严重程度和心智化能力的可行性 20.08.2020，1.0 版