Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD): A Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II)
研究概览
简要总结
A feasibility and pilot trial to investigate the feasibility of a newly manualized psychotherapy "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)"
详细描述
Background: Conduct Disorder is a severe and complex mental disorder with the highest incidence in adolescence. Previous studies have shown that family-oriented interventions are effective in the treatment of Conduct Disorder. However, most therapies focus rather on symptom management and less on etiological causes without inclusion of the family in the therapeutic process. Previous research has linked specific symptoms of Conduct Disorder with deficits in mentalization ability. Mentalization is the ability to perceive one's own and other's behavior as the product of affective and cognitive mental states. Low or missing mentalization abilities are regarded as a risk factor for the development and chronification of Conduct Disorder.
Aims: The study aims to investigate the feasibility of a newly manualized psychotherapy "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)" that strives to decrease symptoms associated with Conduct Disorder by increasing mentalization in adolescents and their families.
Methods: The study is feasibility and piolot trial, carried out in Heidelberg (Germany), and Mainz (Germany). Adolescents aged between 11-18, who meet the DSM-5 criteria for Conduct Disorder will receive MBT-CD. Times of measurement: t0 (Screening), T1 (Baseline, at the beginning of therapy), T2 (3 months after the beginning of therapy), T3 (at the end of therapy, after 6 months), T4 (follow-up, after 9 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •main diagnosis conduct disorder (DSM-5 312.81,312.82)
- •written informed consent
排除标准
- •acute substance dependence
- •sexual offenses
- •acute psychotic symptoms, early or early-onset schizophrenia
- •neurological impairments and low intelligence (IQ <80)
- •non-German-speaking
- •other clinical contra indication for outpatient psychotherapy (e.g. acute suicidality)
结局指标
主要结局
Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II)
时间窗: Change from baseline in SCID-II at 12 months (at the end of therapy)
Subtypes of Antisocial Behaviour Questionnaire (STAB)
时间窗: Change from baseline in STAB at 18 months (follow-up)
Reactive-Proactive-Aggression Questionnaire (RPQ)
时间窗: Change from baseline in RPQ at 18 months (follow-up)
次要结局
- Clinical Global Impression (CGI-SI)(Change from baseline in CGI-SI at 12 months (at the end of therapy))
- Movie for the Assessment of Social Cognition (MASC)(Change from baseline in MASC at 12 months (at the end of therapy))
- Social Hierarchy Task (SHT)(Change from baseline in SHT at 12 months (at the end of therapy))
- Global Assessment of Functioning (GAF)(Change from baseline in GAF at 12 months (at the end of therapy))
- Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)(Change from baseline in LoPF-QA at 18 months (follow-up))
- Stress Index for Parents of Adolescents (SIPA)(Change from baseline in SIPA at 18 months (follow-up))
- drop-out rates(after 12 months (at the end of therapy))
- cost-effectiveness(after 12 months (at the end of therapy))
- Reflective Functioning Questionnaire (RFQ)(Change from baseline in RFQ at 18 months (follow-up))
- 10 round Trust Game Task (TGT)(Change from baseline in TGT at 12 months (at the end of therapy))
- Symptom Checklist-90-Revised (SCL-90R)(Change from baseline in SCL-90R at 12 months (at the end of therapy))
- Approach-Avoidance Task (AAT)(Change from baseline in AAT at 12 months (at the end of therapy))
研究者
Svenja Taubner
Prof. Dr.
Heidelberg University