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

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)?

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07181928
Acronym
MEDAL
Enrollment
90
Registered
2025-09-18
Start date
2025-10-01
Completion date
2028-08-31
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conduct Disorders in Adolescence, Oppositional Defiant Disorder

Keywords

Adolescence, MBT, Conduct Disorder, Externalizing behaviour disorders, Treatment-as-usual

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.

Interventions

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.

BEHAVIORALTreatment-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.

Sponsors

Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie
CollaboratorUNKNOWN
University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 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)

Design outcomes

Primary

MeasureTime frameDescription
Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disordersDay 0, Month 14Remission 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

MeasureTime frameDescription
Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB)day 0 month 11 and month 14Score range 11 - 55, with higher score representing higher value of Social aggression
Quality of life assessed with the Kidscreen 10 Indexday 0, month 11, month 14Score 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 14Score range: 0 - 40, with higher score representing higher value of difficulties or strengths respectively
Aggressive behavior assessed with the german Modified Overt Aggression Scale (MOAS-D)day 0, month 11 month 14Score range: 0 - 300, with higher score representing higher value of aggressive behavior
Gender typicality assessed with the Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter (GRI-JUG)day 0, month 14There 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 14Score range: 12-48, with higher score representing higher value of personality pathology
Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP)day 0, month 14Score range: 0 - 7, with higher score represeting higher value of overall capacity level

Countries

Germany

Contacts

Primary ContactMeike M. Hurrle, Dipl.-Psych.
Meike.Hurrle@med.uni-heidelberg.de+496221 56-39528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026