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

May 17, 2022 updated by: Svenja Taubner, Heidelberg University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Heidelberg, Germany, 69115
        • Heidelberg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: MBT-CD
Mentalization-based treatment program
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Assessment of Functioning (GAF)
Time Frame: Change from baseline in GAF at 12 months (at the end of therapy)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change from baseline in SIPA at 18 months (follow-up)
drop-out rates
Time Frame: after 12 months (at the end of therapy)
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
after 12 months (at the end of therapy)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Alliance Inventory (WAI)
Time Frame: Change from baseline in WAI at 6 months
Treatment related variable (moderator)
Change from baseline in WAI at 6 months
Working Alliance Inventory (WAI)
Time Frame: Change from baseline in WAI at 12 months (at the end of therapy)
Treatment related variable (moderator)
Change from baseline in WAI at 12 months (at the end of therapy)
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)
Change from baseline in ECR-R at 12 months (at the end of therapy)
Emotion Regulation Questionnaire (ERQ)
Time Frame: Change from baseline in ERQ at 12 months (at the end of therapy)
Treatment related variable (moderator)
Change from baseline in ERQ at 12 months (at the end of therapy)
Emotion Regulation Questionnaire (ERQ)
Time Frame: Change from baseline in ERQ at 18 months (follow-up)
Treatment related variable (moderator)
Change from baseline in ERQ at 18 months (follow-up)
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)
Change from baseline in ZKE at 12 months (at the end of therapy)
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)
Change from baseline in MINI at 12 months (at the end of therapy)
Youth Psychopathy Traits Inventory (YPI)
Time Frame: only baseline assessment
Treatment related variable (moderator)
only baseline assessment
Cultural-Fair-Test (CFT-2)
Time Frame: only baseline assessment
Treatment related variable (moderator)
only baseline assessment
Childhood Experience of Care and Abuse Questionnaire (CECA-Q)
Time Frame: only baseline assessment
Treatment related variable (moderator)
only baseline assessment
Dimensional Assessment of Personality Pathology - Basic Questionnaire (DAPP-BQ)
Time Frame: only baseline assessment
Treatment related variable (moderator)
only baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Svenja Taubner, Prof., Institute for Psychosocial Prevention, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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