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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD): A Randomized Controlled Trial

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).

Detailed Summary:

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 Innsbruck (Austria). 102 adolescents aged between 12-17, 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).


Sponsor: Heidelberg University

Current Primary Outcome:

  • 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) ]
  • Subtypes of Antisocial Behaviour Questionnaire (STAB) [ Time Frame: Change from baseline in STAB at 6 months ]
  • Subtypes of Antisocial Behaviour Questionnaire (STAB) [ Time Frame: Change from baseline in STAB at 12 months (at the end of therapy) ]
  • Subtypes of Antisocial Behaviour Questionnaire (STAB) [ Time Frame: Change from baseline in STAB at 18 months (follow-up) ]
  • Reactive-Proactive-Aggression Questionnaire (RPQ) [ Time Frame: Change from baseline in RPQ at 6 months ]
  • Reactive-Proactive-Aggression Questionnaire (RPQ) [ Time Frame: Change from baseline in RPQ at 12 months (at the end of therapy) ]
  • Reactive-Proactive-Aggression Questionnaire (RPQ) [ Time Frame: Change from baseline in RPQ at 18 months (follow-up) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: November 30, 2016
Date Started: December 2016
Date Completion: June 2019
Last Updated: January 12, 2017
Last Verified: January 2017