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NCT Number: NCT07181928

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

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.

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Key information

Conditions

Conduct Disorders in Adolescence Attention Deficit and Disruptive Behavior Disorders Conduct Disorder Mental Disorders Neurodevelopmental Disorders Oppositional Defiant Disorder

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location contact

Dipl.-Psych. Meike Hurrle

CONTACT

[email protected]

+496221 56-39528

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders

    Time frame: 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 outcomes

  1. Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D)

    Time frame: day 0, month 11 month 14

    Score range: 0 - 300, with higher score representing higher value of aggressive behavior

  2. Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB)

    Time frame: day 0 month 11 and month 14

    Score range 11 - 55, with higher score representing higher value of Social aggression

  3. Quality of life assessed with the Kidscreen 10 Index

    Time frame: day 0, month 11, month 14

    Score range: 10-50, with higher scores representing better quality of life

  4. Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ)

    Time frame: day 0, month 11, month 14

    Score range: 0 - 40, with higher score representing higher value of difficulties or strengths respectively

  5. Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP)

    Time frame: day 0, month 14

    Score range: 0 - 7, with higher score represeting higher value of overall capacity level

  6. Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG)

    Time frame: 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.

  7. Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF)

    Time frame: day 0, month 11, month 14

    Score range: 12-48, with higher score representing higher value of personality pathology

Study contacts

Contact information is provided by the study sponsor or research team.

Meike M. Hurrle, Dipl.-Psych.

CONTACT

[email protected]

+496221 56-39528

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie

Registry information

Official study title

Is Mentalization-based Therapy More Effective for Adolescents With Disruptive and Dissocial Disorders Than TAU-plus (Emotion-focused Parent Training With Supportive Child Psychiatric Care)?

Acronym: MEDAL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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