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Clinical Trials in Germany / NCT07181928
Starting soon Not applicable

Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders?

NCT07181928 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2025-09-18

Condition(s) studied

Conduct Disorders in AdolescenceOppositional Defiant Disorder

Investigational drug(s) / intervention(s)

Mentalization-Based Therapy (MBT)Treatment-as-usual-plus (TAU-plus)

Mentalization-Based Therapy (MBT): 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.

Treatment-as-usual-plus (TAU-plus): 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.

Study summary

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

Sex
ALL
Min age
12 Years
Max age
19 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg Heidelberg Baden-Wurttemberg

More University Hospital Heidelberg trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07181928 on ClinicalTrials.gov ↗ ← All trials in Germany