An interventional study of Mentalization-Based Therapy (MBT) and Treatment-as-usual-plus (TAU-plus) in Conduct Disorders in Adolescence and Oppositional Defiant Disorder, sponsored by University Hospital Heidelberg. Not yet recruiting at 1 site in Germany. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by University Hospital Heidelberg · Not applicable, Interventional, and Treatment
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.
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.
86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.
This study's planned enrollment of 90 is below the median of 102 across 76 interventional studies indexed under Oppositional Defiant Disorder.
Browse Oppositional Defiant Disorder studies →University Hospital Heidelberg is the lead sponsor of 177 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive MBT over 10 months. The patients have 30 individual sessions weekly conducted by one therapist with formal training in MBT. Additionally, the patient receives 5 sessions together with the parents and the parents will have another 5 sessions without the patient.
Behavioral: Mentalization-Based Therapy (MBT)
45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive standard psychiatric care over 10 months and their parents will participate in the Emotion Focused Skills Training (EFST). The patient receives individual psychiatric sessions at least two per quarter depending on the adolescent's needs. The individual sessions are conducted by a child and adolescent psychiatrist and/or by a therapist working under their supervision. EFST includes an intake session, 5 two-hour group sessions (6-12 parents, led by two therapists), and a final individual session.
Behavioral: Treatment-as-usual-plus (TAU-plus)
MBT 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.
The 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.
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).
Time frame: Day 0, Month 14
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
Time frame: day 0, month 11 month 14
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
Time frame: day 0 month 11 and month 14
Quality of life assessed with the Kidscreen 10 Index
Score range: 10-50, with higher scores representing better quality of life
Time frame: day 0, month 11, month 14
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
Time frame: day 0, month 11, month 14
Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP)
Score range: 0 - 7, with higher score represeting higher value of overall capacity level
Time frame: day 0, month 14
Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG)
There are four subscales - femenine positive and negative and Masculine positive and negative. Score range for each subscale: 1-5, with high scores indicate a high expression of the respective facet of the gender role self-concept.
Time frame: day 0, month 14
Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF)
Score range: 12-48, with higher score representing higher value of personality pathology
Time frame: day 0, month 11, month 14
Plan to share: No — Data is too sensitive
Start is estimated for Oct 2025; primary completion for Aug 2028, 34 months later.
Of 35 non-industry interventional studies with no phase under Oppositional Defiant Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 34 months is above that.
Counting every sponsor, half of 36 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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