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

N/ANot Yet RecruitingNCT07181928

University Hospital Heidelberg90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

Mentalization-Based Therapy (MBT)BEHAVIORAL

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)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 19 Years

Medical Language ↔ Plain English

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)

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).

Time frame: Day 0, Month 14

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts