About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Mentalization-Based Therapy (MBT)
BehavioralMBT is a manualized psychodynamic therapy based on attachment theory, designed to restore adolescents' mentalizing in general and in emotionally stressful situations and relationships. It targets to rebuilt epistemic trust, to successfully mentalize oneself and others.
Treatment-as-usual-plus (TAU-plus)
BehavioralThe adolescents receive supportive child psychiatric consultations. For the parents the EFST sessions combine mindfulness, theoretical input, and experiential practice. Parents learn and apply four core skills: validation, repair, motivation, and setting boundaries.
Treatment groups
Trial outcomes
Primary outcomes
Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders
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).
Secondary outcomes
Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D)
Score range: 0 - 300, with higher score representing higher value of aggressive behavior
Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB)
Score range 11 - 55, with higher score representing higher value of Social aggression
Quality of life assessed with the Kidscreen 10 Index
Score range: 10-50, with higher scores representing better quality of life
Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ)
Score range: 0 - 40, with higher score representing higher value of difficulties or strengths respectively
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Heidelberg
Lead sponsor
Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie
Collaborator
This trial is not recruiting at the moment. You can still explore other options: