Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D) | Score range: 0 - 300, with higher score representing higher value of aggressive behavior | day 0, month 11 month 14 |
| Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meike M. Hurrle, Dipl.-Psych. | Contact | +496221 56-39528 | Meike.Hurrle@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Svenja Taubner, Prof. Dr. | Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg | Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35664189 | Background | 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. | |
| 3418327 | 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. |
Not provided
Not provided
Data is too sensitive
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Score range 11 - 55, with higher score representing higher value of Social aggression |
| day 0 month 11 and month 14 |
| Quality of life assessed with the Kidscreen 10 Index | Score range: 10-50, with higher scores representing better quality of life | day 0, month 11, month 14 |
| Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ) | Score range: 0 - 40, with higher score representing higher value of difficulties or strengths respectively | day 0, month 11, month 14 |
| Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP) | Score range: 0 - 7, with higher score represeting higher value of overall capacity level | day 0, month 14 |
| Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG) | 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. | day 0, month 14 |
| Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF) | Score range: 12-48, with higher score representing higher value of personality pathology | day 0, month 11, month 14 |
| 23988834 | 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. |
| 33694153 | 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. |
| 38167355 | 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. |
| 14526759 | 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. |
| 23686556 | 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. |
| 19618380 | 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. |
| ID | Term |
|---|---|
| D000096865 | Oppositional Defiant Disorder |
| D019955 | Conduct Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000088042 | Mentalization-Based Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided