Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD)

Study Overview
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Brief Summary
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A feasibility and pilot trial to investigate the feasibility of a newly manualized psychotherapy Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)

Detailed Description
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Background: Conduct Disorder is a severe and complex mental disorder with the highest incidence in adolescence. Previous studies have shown that family-oriented interventions are effective in the treatment of Conduct Disorder. However, most therapies focus rather on symptom management and less on etiological causes without inclusion of the family in the therapeutic process. Previous research has linked specific symptoms of Conduct Disorder with deficits in mentalization ability. Mentalization is the ability to perceive one's own and other's behavior as the product of affective and cognitive mental states. Low or missing mentalization abilities are regarded as a risk factor for the development and chronification of Conduct Disorder. Aims: The study aims to investigate the feasibility of a newly manualized psychotherapy Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD) that strives to decrease symptoms associated with Conduct Disorder by increasing mentalization in adolescents and their families. Methods: The study is feasibility and piolot trial, carried out in Heidelberg (Germany), and Mainz (Germany). Adolescents aged between 11-18, who meet the DSM-5 criteria for Conduct Disorder will receive MBT-CD. Times of measurement: t0 (Screening), T1 (Baseline, at the beginning of therapy), T2 (3 months after the beginning of therapy), T3 (at the end of therapy, after 6 months), T4 (follow-up, after 9 months).

Official Title
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Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD): A Feasibility and Pilot Study

Conditions
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Conduct Disorder

Intervention / Treatment
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* Other: MBT-CD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: main diagnosis conduct disorder (DSM-5 312.81,312.82) written informed consent Exclusion Criteria: acute substance dependence sexual offenses acute psychotic symptoms, early or early-onset schizophrenia neurological impairments and low intelligence (IQ <80) non-German-speaking other clinical contra indication for outpatient psychotherapy (e.g. acute suicidality)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBT-CD<br>Mentalization-based treatment program | Other: MBT-CD<br>* MBT-CD is a disorder-specific modification of MBT, initially developed for patients with Borderline Personality Disorder. It is a manualized and psychodynamically oriented psychotherapy with the aim to increase the mentalization capacity of adolescents in close relationships. The therapy consists of 2 psychoeducational group sessions, 30 individual therapy sessions and 10 family sessions. The average duration of therapy is 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II) |  | Change from baseline in SCID-II at 12 months (at the end of therapy) | 
| Subtypes of Antisocial Behaviour Questionnaire (STAB) |  | Change from baseline in STAB at 6 months | 
| Subtypes of Antisocial Behaviour Questionnaire (STAB) |  | Change from baseline in STAB at 12 months (at the end of therapy) | 
| Subtypes of Antisocial Behaviour Questionnaire (STAB) |  | Change from baseline in STAB at 18 months (follow-up) | 
| Reactive-Proactive-Aggression Questionnaire (RPQ) |  | Change from baseline in RPQ at 6 months | 
| Reactive-Proactive-Aggression Questionnaire (RPQ) |  | Change from baseline in RPQ at 12 months (at the end of therapy) | 
| Reactive-Proactive-Aggression Questionnaire (RPQ) |  | Change from baseline in RPQ at 18 months (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Functioning (GAF) |  | Change from baseline in GAF at 12 months (at the end of therapy) | 
| Clinical Global Impression (CGI-SI) |  | Change from baseline in CGI-SI at 12 months (at the end of therapy) | 
| Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA) |  | Change from baseline in LoPF-QA at 12 months (at the end of therapy) | 
| Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA) |  | Change from baseline in LoPF-QA at 18 months (follow-up) | 
| Reflective Functioning Questionnaire (RFQ) |  | Change from baseline in RFQ at 12 months (at the end of therapy) | 
| Reflective Functioning Questionnaire (RFQ) |  | Change from baseline in RFQ at 18 months (follow-up) | 
| Movie for the Assessment of Social Cognition (MASC) |  | Change from baseline in MASC at 12 months (at the end of therapy) | 
| 10 round Trust Game Task (TGT) |  | Change from baseline in TGT at 12 months (at the end of therapy) | 
| Social Hierarchy Task (SHT) |  | Change from baseline in SHT at 12 months (at the end of therapy) | 
| Approach-Avoidance Task (AAT) |  | Change from baseline in AAT at 12 months (at the end of therapy) | 
| Symptom Checklist-90-Revised (SCL-90R) |  | Change from baseline in SCL-90R at 12 months (at the end of therapy) | 
| Stress Index for Parents of Adolescents (SIPA) |  | Change from baseline in SIPA at 12 months (at the end of therapy) | 
| Stress Index for Parents of Adolescents (SIPA) |  | Change from baseline in SIPA at 18 months (follow-up) | 
| drop-out rates |  | after 12 months (at the end of therapy) | 
| cost-effectiveness | Cost-effectiveness will be measured by participation in training/school, rehospitalization, internment | after 12 months (at the end of therapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mentalization-based treatment, conduct disorder, adolescents