Is Mentalization-based Therapy More Effective for Adolescents With Disruptive and Dissocial Disorders Than TAU-plus (Emotion-focused Parent Training With Supportive Child Psychiatric Care)?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders
研究概览
简要总结
The goal of this clinical trial is to investigate if Mentalization-based therapy (MBT) is superior to enhanced usual care (treatment-as-usual-plus (TAU-plus)) for adolescents with disruptive behavior or dissocial disorders.
MBT is an intervention that aims to improve mentalizing. Mentalizing is the ability to reflect on mental states in oneself and others that motivate behavior. TAU-plus consists of psychiatric care for the adolescent, along with additional emotion-focused skills training for the parents.
Participants will be randomized in one of two groups using one study center.
详细描述
The study includes adolescents between the ages 12 to 19 of any gender who have been diagnosed with Oppositional defiant or Conduct-dissocial disorder (serious problems with following rules or criminal behavior).
The diagnosis is the primary outcome, which is assessed based on a diagnostic interview. Secondary outcomes include antisocial behavior, quality of life, symptom burden, and personality functioning (measured through self-report questionnaires), as well as aggressive behavior (measured through interview).
During the study, there will be monthly process assessments. In these assessments, participants will be asked questions about mentalizing, emotion regulation, therapy experience, antisocial behavior, and how much they trust others. These variables are considered mediators of changes in outcome.
Participants will also be interviewed regarding personality functioning to investigate whether dissocial disorders are related to personality disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Oppositional defiant disorder (ODD) / Conduct-dissocial disorder (CDD) (ICD-11: 6C90-6C91; ICD-10: F91.0-F91.9; DSM-5: 312.81, 313.81)
- •Aged 12 to 19 years
- •Living with their parents
- •Provide written informed consent (plus parental consent for minors)
- •At least one parent provides written informed consent and agrees to active participation in treatment and study, including randomization
排除标准
- •Severe acute substance dependence requiring inpatient detoxification
- •Acute psychotic symptoms or early-onset schizophrenia
- •Neurological impairments or intellectual disability (IQ < 80)
- •Insufficient proficiency in German
- •Other clinical contraindications for outpatient psychotherapy (e.g., acute suicidality)
结局指标
主要结局
Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders
时间窗: Day 0, Month 14
Remission is defined as the proportion of participants no longer meeting full diagnostic criteria for Conduct-dissocial disorder (CDD) or Oppositional defiant disorder (ODD). CDD is assessed with the "Diagnostisches Interview bei psychischen Störungen - Version für Jugendlichen" (J-DIPS) and ODD with the "Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter" (K-DIPS).
次要结局
- Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D)(day 0, month 11 month 14)
- Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB)(day 0 month 11 and month 14)
- Quality of life assessed with the Kidscreen 10 Index(day 0, month 11, month 14)
- Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ)(day 0, month 11, month 14)
- Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP)(day 0, month 14)
- Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG)(day 0, month 14)
- Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF)(day 0, month 11, month 14)
研究者
Svenja Taubner
Prof. Dr. phil. Svenja Taubner
University Hospital Heidelberg