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

University Hospital Heidelberg

Status: Not yet enrolling

Conditions: Oppositional Defiant Disorder; Conduct Disorders in Adolescence

Treatments: Behavioral: Treatment-as-usual-plus (TAU-plus); Behavioral: Mentalization-Based Therapy (MBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07181928

Tau 2025 1/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 2 patient groups

Mentalization-Based Therapy (MBT)

Experimental group

Description:

45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive MBT over 10 months. The patients have 30 individual sessions weekly conducted by one therapist with formal training in MBT. Additionally, the patient receives 5 sessions together with the parents and the parents will have another 5 sessions without the patient.

Treatment:

Behavioral: Mentalization-Based Therapy (MBT)

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

Active Comparator group

Description:

45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive standard psychiatric care over 10 months and their parents will participate in the Emotion Focused Skills Training (EFST). The patient receives individual psychiatric sessions at least two per quarter depending on the adolescent's needs. The individual sessions are conducted by a child and adolescent psychiatrist and/or by a therapist working under their supervision. EFST includes an intake session, 5 two-hour group sessions (6-12 parents, led by two therapists), and a final individual session.

Treatment:

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