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

Официальное название

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)?

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Mentalization-Based Therapy (MBT)
  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.
• Поведенческое Treatment-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.

Первичные конечные точки

• Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders [Срок оценки: Day 0, Month 14]

Вторичные конечные точки (7)

• Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D) [Срок оценки: day 0, month 11 month 14]
• Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB) [Срок оценки: day 0 month 11 and month 14]
• Quality of life assessed with the Kidscreen 10 Index [Срок оценки: day 0, month 11, month 14]
• Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: day 0, month 11, month 14]
• Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP) [Срок оценки: day 0, month 14]
• Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG) [Срок оценки: day 0, month 14]
• Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF) [Срок оценки: day 0, month 11, month 14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg — Heidelberg

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07181928 · Tau 2025 1/2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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