- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02988453
Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD) (MBT-CD)
Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD): A Feasibility and Pilot Study
Study Overview
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Heidelberg, Germany, 69115
- Heidelberg University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MBT-CD
Mentalization-based treatment program
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II)
Time Frame: Change from baseline in SCID-II at 12 months (at the end of therapy)
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Change from baseline in SCID-II at 12 months (at the end of therapy)
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Subtypes of Antisocial Behaviour Questionnaire (STAB)
Time Frame: Change from baseline in STAB at 6 months
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Change from baseline in STAB at 6 months
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Subtypes of Antisocial Behaviour Questionnaire (STAB)
Time Frame: Change from baseline in STAB at 12 months (at the end of therapy)
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Change from baseline in STAB at 12 months (at the end of therapy)
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Subtypes of Antisocial Behaviour Questionnaire (STAB)
Time Frame: Change from baseline in STAB at 18 months (follow-up)
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Change from baseline in STAB at 18 months (follow-up)
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Reactive-Proactive-Aggression Questionnaire (RPQ)
Time Frame: Change from baseline in RPQ at 6 months
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Change from baseline in RPQ at 6 months
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Reactive-Proactive-Aggression Questionnaire (RPQ)
Time Frame: Change from baseline in RPQ at 12 months (at the end of therapy)
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Change from baseline in RPQ at 12 months (at the end of therapy)
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Reactive-Proactive-Aggression Questionnaire (RPQ)
Time Frame: Change from baseline in RPQ at 18 months (follow-up)
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Change from baseline in RPQ at 18 months (follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Global Assessment of Functioning (GAF)
Time Frame: Change from baseline in GAF at 12 months (at the end of therapy)
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Change from baseline in GAF at 12 months (at the end of therapy)
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Clinical Global Impression (CGI-SI)
Time Frame: Change from baseline in CGI-SI at 12 months (at the end of therapy)
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Change from baseline in CGI-SI at 12 months (at the end of therapy)
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Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)
Time Frame: Change from baseline in LoPF-QA at 12 months (at the end of therapy)
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Change from baseline in LoPF-QA at 12 months (at the end of therapy)
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Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)
Time Frame: Change from baseline in LoPF-QA at 18 months (follow-up)
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Change from baseline in LoPF-QA at 18 months (follow-up)
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Reflective Functioning Questionnaire (RFQ)
Time Frame: Change from baseline in RFQ at 12 months (at the end of therapy)
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Change from baseline in RFQ at 12 months (at the end of therapy)
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Reflective Functioning Questionnaire (RFQ)
Time Frame: Change from baseline in RFQ at 18 months (follow-up)
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Change from baseline in RFQ at 18 months (follow-up)
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Movie for the Assessment of Social Cognition (MASC)
Time Frame: Change from baseline in MASC at 12 months (at the end of therapy)
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Change from baseline in MASC at 12 months (at the end of therapy)
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10 round Trust Game Task (TGT)
Time Frame: Change from baseline in TGT at 12 months (at the end of therapy)
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Change from baseline in TGT at 12 months (at the end of therapy)
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Social Hierarchy Task (SHT)
Time Frame: Change from baseline in SHT at 12 months (at the end of therapy)
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Change from baseline in SHT at 12 months (at the end of therapy)
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Approach-Avoidance Task (AAT)
Time Frame: Change from baseline in AAT at 12 months (at the end of therapy)
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Change from baseline in AAT at 12 months (at the end of therapy)
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Symptom Checklist-90-Revised (SCL-90R)
Time Frame: Change from baseline in SCL-90R at 12 months (at the end of therapy)
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Change from baseline in SCL-90R at 12 months (at the end of therapy)
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Stress Index for Parents of Adolescents (SIPA)
Time Frame: Change from baseline in SIPA at 12 months (at the end of therapy)
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Change from baseline in SIPA at 12 months (at the end of therapy)
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Stress Index for Parents of Adolescents (SIPA)
Time Frame: Change from baseline in SIPA at 18 months (follow-up)
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Change from baseline in SIPA at 18 months (follow-up)
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drop-out rates
Time Frame: after 12 months (at the end of therapy)
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after 12 months (at the end of therapy)
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cost-effectiveness
Time Frame: after 12 months (at the end of therapy)
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Cost-effectiveness will be measured by participation in training/school, rehospitalization, internment
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after 12 months (at the end of therapy)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Working Alliance Inventory (WAI)
Time Frame: Change from baseline in WAI at 6 months
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Treatment related variable (moderator)
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Change from baseline in WAI at 6 months
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Working Alliance Inventory (WAI)
Time Frame: Change from baseline in WAI at 12 months (at the end of therapy)
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Treatment related variable (moderator)
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Change from baseline in WAI at 12 months (at the end of therapy)
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Experiences in Close Relationships - Revised (ECR-R)
Time Frame: Change from baseline in ECR-R at 12 months (at the end of therapy)
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Treatment related variable (moderator)
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Change from baseline in ECR-R at 12 months (at the end of therapy)
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Emotion Regulation Questionnaire (ERQ)
Time Frame: Change from baseline in ERQ at 12 months (at the end of therapy)
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Treatment related variable (moderator)
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Change from baseline in ERQ at 12 months (at the end of therapy)
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Emotion Regulation Questionnaire (ERQ)
Time Frame: Change from baseline in ERQ at 18 months (follow-up)
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Treatment related variable (moderator)
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Change from baseline in ERQ at 18 months (follow-up)
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Zurich Brief Questionnaire for the Assessment of Parental Behaviors (ZKE)
Time Frame: Change from baseline in ZKE at 12 months (at the end of therapy)
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Treatment related variable (moderator)
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Change from baseline in ZKE at 12 months (at the end of therapy)
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The Mini-International Neuropsychiatric Interview (MINI)
Time Frame: Change from baseline in MINI at 12 months (at the end of therapy)
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Treatment related variable (moderator)
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Change from baseline in MINI at 12 months (at the end of therapy)
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Youth Psychopathy Traits Inventory (YPI)
Time Frame: only baseline assessment
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Treatment related variable (moderator)
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only baseline assessment
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Cultural-Fair-Test (CFT-2)
Time Frame: only baseline assessment
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Treatment related variable (moderator)
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only baseline assessment
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Childhood Experience of Care and Abuse Questionnaire (CECA-Q)
Time Frame: only baseline assessment
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Treatment related variable (moderator)
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only baseline assessment
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Dimensional Assessment of Personality Pathology - Basic Questionnaire (DAPP-BQ)
Time Frame: only baseline assessment
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Treatment related variable (moderator)
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only baseline assessment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Svenja Taubner, Prof., Institute for Psychosocial Prevention, Heidelberg University
Publications and helpful links
General Publications
- Taubner S, Zimmermann L, Ramberg A, Schroder P. Mentalization Mediates the Relationship between Early Maltreatment and Potential for Violence in Adolescence. Psychopathology. 2016;49(4):236-246. doi: 10.1159/000448053. Epub 2016 Aug 23.
- Rossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1304-1313.e3. doi: 10.1016/j.jaac.2012.09.018.
- Taubner S, White LO, Zimmermann J, Fonagy P, Nolte T. Attachment-related mentalization moderates the relationship between psychopathic traits and proactive aggression in adolescence. J Abnorm Child Psychol. 2013 Aug;41(6):929-38. doi: 10.1007/s10802-013-9736-x.
- McGauley G, Yakeley J, Williams W, Bateman AW. Attachment, mentalization and antisocial personality disorder. The possible contribution of mentalization-based treatment. European Journal of Psychotherapy & Counselling. 2011; 13 (4): 371-393; doi: 10.1080/13642537.2011.629118.
- Taubner S, Hauschild S, Kasper L, Kaess M, Sobanski E, Gablonski TC, Schroder-Pfeifer P, Volkert J. Mentalization-based treatment for adolescents with conduct disorder (MBT-CD): protocol of a feasibility and pilot study. Pilot Feasibility Stud. 2021 Jul 2;7(1):139. doi: 10.1186/s40814-021-00876-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23011229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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