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

Not Applicable

Not yet recruiting

• Conditions: Conduct Disorders in Adolescence; Oppositional Defiant Disorder

• Registration Number: NCT07181928
• Lead Sponsor: University Hospital Heidelberg

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-08-01
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-01
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders	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).

Secondary Outcome Measures

Name	Time	Method
Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D)	day 0, month 11 month 14	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)	day 0 month 11 and month 14	Score range 11 - 55, with higher score representing higher value of Social aggression
Quality of life assessed with the Kidscreen 10 Index	day 0, month 11, month 14	Score range: 10-50, with higher scores representing better quality of life
Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ)	day 0, month 11, month 14	Score range: 0 - 40, with higher score representing higher value of difficulties or strengths respectively
Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP)	day 0, month 14	Score range: 0 - 7, with higher score represeting higher value of overall capacity level
Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG)	day 0, month 14	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.
Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF)	day 0, month 11, month 14	Score range: 12-48, with higher score representing higher value of personality pathology

Trial Locations

Locations (1)

Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg; 🇩🇪 Heidelberg, Baden-Wurttemberg, Germany