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

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ClinicalTrials.gov Identifier: NCT02988453
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Heidelberg University, Psychotherapy Research Department
Heidelberg University, Clinic for Child and Youth Psychiatry
KABEG Management
Mainz Johannes Gutenberg University, Clinic for Child and Youth Psychiatry and Psychotherapy
Information provided by (Responsible Party):
Svenja Taubner, Heidelberg University

Brief Summary:
A single blind, randomized controlled trial to investigate the efficacy of a newly manualized psychotherapy "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)" in comparison with Treatment As Usual (TAU).

Condition or disease Intervention/treatment Phase
Conduct Disorder Other: MBT-CD Other: treatment as usual (TAU) Not Applicable

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 efficacy 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 a single blind, randomized controlled trial, carried out in Heidelberg (Germany), Klagenfurt (Austria) and Mainz (Germany). 102 adolescents aged between 12-18, who meet the DSM-5 criteria for Conduct Disorder will be randomized to either MBT or TAU. Times of measurement: t0 (Screening), T1 (Baseline, at the beginning of therapy), T2 (6 months after the beginning of therapy), T3 (at the end of therapy, after 12 months), T4 (follow-up, after 18 months).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD): A Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: MBT-CD
Mentalization-based treatment program
Other: MBT-CD
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 6 psychoeducational group sessions, 30 individual therapy sessions and 10 family sessions. The average duration of therapy is 12 months.

Active Comparator: treatment as usual (TAU)
treatment as usual group
Other: treatment as usual (TAU)
Patients in TAU will receive standard routine care provided in the German health care system. They will be assessed and advised for treatment at an outpatient clinic for adolescents with self-harming, aggressive or antisocial behavior.




Primary Outcome Measures :
  1. 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) ]
  2. Subtypes of Antisocial Behaviour Questionnaire (STAB) [ Time Frame: Change from baseline in STAB at 6 months ]
  3. Subtypes of Antisocial Behaviour Questionnaire (STAB) [ Time Frame: Change from baseline in STAB at 12 months (at the end of therapy) ]
  4. Subtypes of Antisocial Behaviour Questionnaire (STAB) [ Time Frame: Change from baseline in STAB at 18 months (follow-up) ]
  5. Reactive-Proactive-Aggression Questionnaire (RPQ) [ Time Frame: Change from baseline in RPQ at 6 months ]
  6. Reactive-Proactive-Aggression Questionnaire (RPQ) [ Time Frame: Change from baseline in RPQ at 12 months (at the end of therapy) ]
  7. Reactive-Proactive-Aggression Questionnaire (RPQ) [ Time Frame: Change from baseline in RPQ at 18 months (follow-up) ]

Secondary Outcome Measures :
  1. Global Assessment of Functioning (GAF) [ Time Frame: Change from baseline in GAF at 12 months (at the end of therapy) ]
  2. Clinical Global Impression (CGI-SI) [ Time Frame: Change from baseline in CGI-SI at 12 months (at the end of therapy) ]
  3. Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA) [ Time Frame: Change from baseline in LoPF-QA at 12 months (at the end of therapy) ]
  4. Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA) [ Time Frame: Change from baseline in LoPF-QA at 18 months (follow-up) ]
  5. Reflective Functioning Questionnaire (RFQ) [ Time Frame: Change from baseline in RFQ at 12 months (at the end of therapy) ]
  6. Reflective Functioning Questionnaire (RFQ) [ Time Frame: Change from baseline in RFQ at 18 months (follow-up) ]
  7. Movie for the Assessment of Social Cognition (MASC) [ Time Frame: Change from baseline in MASC at 12 months (at the end of therapy) ]
  8. 10 round Trust Game Task (TGT) [ Time Frame: Change from baseline in TGT at 12 months (at the end of therapy) ]
  9. Social Hierarchy Task (SHT) [ Time Frame: Change from baseline in SHT at 12 months (at the end of therapy) ]
  10. Approach-Avoidance Task (AAT) [ Time Frame: Change from baseline in AAT at 12 months (at the end of therapy) ]
  11. Symptom Checklist-90-Revised (SCL-90R) [ Time Frame: Change from baseline in SCL-90R at 12 months (at the end of therapy) ]
  12. Stress Index for Parents of Adolescents (SIPA) [ Time Frame: Change from baseline in SIPA at 12 months (at the end of therapy) ]
  13. Stress Index for Parents of Adolescents (SIPA) [ Time Frame: Change from baseline in SIPA at 18 months (follow-up) ]
  14. drop-out rates [ Time Frame: after 12 months (at the end of therapy) ]
  15. cost-effectiveness [ Time Frame: after 12 months (at the end of therapy) ]
    Cost-effectiveness will be measured by participation in training/school, rehospitalization, internment


Other Outcome Measures:
  1. Working Alliance Inventory (WAI) [ Time Frame: Change from baseline in WAI at 6 months ]
    Treatment related variable (moderator)

  2. Working Alliance Inventory (WAI) [ Time Frame: Change from baseline in WAI at 12 months (at the end of therapy) ]
    Treatment related variable (moderator)

  3. Experiences in Close Relationships - Revised (ECR-R) [ Time Frame: Change from baseline in ECR-R at 12 months (at the end of therapy) ]
    Treatment related variable (moderator)

  4. Emotion Regulation Questionnaire (ERQ) [ Time Frame: Change from baseline in ERQ at 12 months (at the end of therapy) ]
    Treatment related variable (moderator)

  5. Emotion Regulation Questionnaire (ERQ) [ Time Frame: Change from baseline in ERQ at 18 months (follow-up) ]
    Treatment related variable (moderator)

  6. 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) ]
    Treatment related variable (moderator)

  7. The Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Change from baseline in MINI at 12 months (at the end of therapy) ]
    Treatment related variable (moderator)

  8. Youth Psychopathy Traits Inventory (YPI) [ Time Frame: only baseline assessment ]
    Treatment related variable (moderator)

  9. Cultural-Fair-Test (CFT-2) [ Time Frame: only baseline assessment ]
    Treatment related variable (moderator)

  10. Childhood Experience of Care and Abuse Questionnaire (CECA-Q) [ Time Frame: only baseline assessment ]
    Treatment related variable (moderator)

  11. Dimensional Assessment of Personality Pathology - Basic Questionnaire (DAPP-BQ) [ Time Frame: only baseline assessment ]
    Treatment related variable (moderator)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988453


Contacts
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Contact: Svenja Taubner, Prof. +49622156 ext 4700 svenja.taubner@med.uni-heidelberg.de
Contact: Sophie Hauschild, M.sc. +49622156 ext 5662 sophie.hauschild@med.uni-heidelberg.de

Locations
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Germany
Heidelberg University Recruiting
Heidelberg, Germany, 69115
Contact: Svenja Taubner, Prof.       Svenja.Taubner@med.uni-heidelberg.de   
Contact: Sophie Hauschild, M.sc.       sophie.hauschild@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Heidelberg University, Psychotherapy Research Department
Heidelberg University, Clinic for Child and Youth Psychiatry
KABEG Management
Mainz Johannes Gutenberg University, Clinic for Child and Youth Psychiatry and Psychotherapy
Investigators
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Principal Investigator: Svenja Taubner, Prof. Institute for Psychosocial Prevention, Heidelberg University

Publications:
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Responsible Party: Svenja Taubner, Prof. Dr., Heidelberg University
ClinicalTrials.gov Identifier: NCT02988453     History of Changes
Other Study ID Numbers: 23011229
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Svenja Taubner, Heidelberg University:
mentalization-based treatment
conduct disorder
adolescents

Additional relevant MeSH terms:
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Disease
Conduct Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders