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

NCT07181928 | Not Yet Recruiting

• 1 other identifier: Tau 2025 1/2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Conduct Disorders in Adolescence; Oppositional Defiant Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 0, Month 14

Secondary Outcomes (7)

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

  day 0, month 11 month 14

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

  day 0 month 11 and month 14

• Quality of life assessed with the Kidscreen 10 Index

  day 0, month 11, month 14

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

  day 0, month 11, month 14

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

  day 0, month 14

Study Arms (2)

Mentalization-Based Therapy (MBT)

EXPERIMENTAL

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.

Behavioral: Mentalization-Based Therapy (MBT)

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

ACTIVE COMPARATOR

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.

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

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.

Mentalization-Based Therapy (MBT)

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.

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

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie: collaborator

Study Sites (1)

Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Related Publications (8)

• Korlat S, Holzer J, Schultes MT, Buerger S, Schober B, Spiel C, Kollmayer M. Benefits of Psychological Androgyny in Adolescence: The Role of Gender Role Self-Concept in School-Related Well-Being. Front Psychol. 2022 May 19;13:856758. doi: 10.3389/fpsyg.2022.856758. eCollection 2022.

  PMID: 35664189 BACKGROUND

• Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46. doi: 10.1097/00005053-198809000-00007.

  PMID: 3418327 BACKGROUND

• Neuschwander M, In-Albon T, Adornetto C, Roth B, Schneider S. [Interrater reliability of the <<Diagnostic Interview bei psychischen Storungen im Kindes- und Jugendalter (Kinder-DIPS)]. Z Kinder Jugendpsychiatr Psychother. 2013 Sep;41(5):319-34. doi: 10.1024/1422-4917//a000247. German.

  PMID: 23988834 BACKGROUND

• Spitzer C, Muller S, Kerber A, Hutsebaut J, Brahler E, Zimmermann J. [The German Version of the Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF): Latent Structure, Convergent Validity and Norm Values in the General Population]. Psychother Psychosom Med Psychol. 2021 Jul;71(7):284-293. doi: 10.1055/a-1343-2396. Epub 2021 Mar 10. German.

  PMID: 33694153 BACKGROUND

• Henning A, Linden M, Muschalla B. Self- and observer ratings of capacity limitations in patients with neurological conditions. Brain Impair. 2023 Dec;24(3):586-600. doi: 10.1017/BrImp.2022.26. Epub 2022 Nov 17.

  PMID: 38167355 BACKGROUND

• Klasen H, Woerner W, Rothenberger A, Goodman R. [German version of the Strength and Difficulties Questionnaire (SDQ-German)--overview and evaluation of initial validation and normative results]. Prax Kinderpsychol Kinderpsychiatr. 2003 Sep;52(7):491-502. German.

  PMID: 14526759 BACKGROUND

• Ravens-Sieberer U, Herdman M, Devine J, Otto C, Bullinger M, Rose M, Klasen F. The European KIDSCREEN approach to measure quality of life and well-being in children: development, current application, and future advances. Qual Life Res. 2014 Apr;23(3):791-803. doi: 10.1007/s11136-013-0428-3. Epub 2013 May 18.

  PMID: 23686556 BACKGROUND

• Burt SA, Donnellan MB. Development and validation of the Subtypes of Antisocial Behavior Questionnaire. Aggress Behav. 2009 Sep-Oct;35(5):376-98. doi: 10.1002/ab.20314.

  PMID: 19618380 BACKGROUND

MeSH Terms

Conditions

Oppositional Defiant Disorder; Conduct Disorder

Interventions

Mentalization-Based Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Svenja Taubner, Prof. Dr.

  Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg

  STUDY DIRECTOR

Central Study Contacts

Meike M. Hurrle, Dipl.-Psych.

CONTACT

+496221 56-39528; Meike.Hurrle@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. phil. Svenja Taubner

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)