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Clinical Trials/NCT02988453
NCT02988453
Completed
Not Applicable

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

Heidelberg University1 site in 1 country45 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Conduct Disorder
Sponsor
Heidelberg University
Enrollment
45
Locations
1
Primary Endpoint
Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Svenja Taubner

Prof. Dr.

Heidelberg University

Eligibility 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)

Outcomes

Primary Outcomes

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 18 months (follow-up)

Reactive-Proactive-Aggression Questionnaire (RPQ)

Time Frame: Change from baseline in RPQ at 18 months (follow-up)

Secondary Outcomes

  • Clinical Global Impression (CGI-SI)(Change from baseline in CGI-SI at 12 months (at the end of therapy))
  • Movie for the Assessment of Social Cognition (MASC)(Change from baseline in MASC 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))
  • Global Assessment of Functioning (GAF)(Change from baseline in GAF 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))
  • 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(after 12 months (at the end of therapy))
  • Reflective Functioning Questionnaire (RFQ)(Change from baseline in RFQ at 18 months (follow-up))
  • 10 round Trust Game Task (TGT)(Change from baseline in TGT 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))
  • Approach-Avoidance Task (AAT)(Change from baseline in AAT at 12 months (at the end of therapy))

Study Sites (1)

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