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

Primary Purpose

Conduct Disorder

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

MBT-CD

About this trial

This is an interventional treatment trial for Conduct Disorder focused on measuring mentalization-based treatment, conduct disorder, adolescents

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Heidelberg University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBT-CD

Arm Description

Mentalization-based treatment program

Outcomes

Primary Outcome Measures

Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II)

Subtypes of Antisocial Behaviour Questionnaire (STAB)

Reactive-Proactive-Aggression Questionnaire (RPQ)

Secondary Outcome Measures

Global Assessment of Functioning (GAF)

Clinical Global Impression (CGI-SI)

Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)

Reflective Functioning Questionnaire (RFQ)

Movie for the Assessment of Social Cognition (MASC)

10 round Trust Game Task (TGT)

Social Hierarchy Task (SHT)

Approach-Avoidance Task (AAT)

Symptom Checklist-90-Revised (SCL-90R)

Stress Index for Parents of Adolescents (SIPA)

drop-out rates

cost-effectiveness

Cost-effectiveness will be measured by participation in training/school, rehospitalization, internment

Full Information

NCT ID

NCT02988453

First Posted

November 30, 2016

Last Updated

May 17, 2022

Sponsor

Heidelberg University

Collaborators

Heidelberg University, Psychotherapy Research Department, Heidelberg University, Clinic for Child and Youth Psychiatry, Johannes Gutenberg University Mainz

1. Study Identification

Unique Protocol Identification Number

NCT02988453

Brief Title

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

Acronym

MBT-CD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

October 2021 (Actual)

Study Completion Date

December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

Collaborators

Heidelberg University, Psychotherapy Research Department, Heidelberg University, Clinic for Child and Youth Psychiatry, Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Conduct Disorder

Keywords

mentalization-based treatment, conduct disorder, adolescents

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MBT-CD

Arm Type

Experimental

Arm Description

Mentalization-based treatment program

Intervention Type

Other

Intervention Name(s)

MBT-CD

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Title

Subtypes of Antisocial Behaviour Questionnaire (STAB)

Time Frame

Change from baseline in STAB at 6 months

Title

Subtypes of Antisocial Behaviour Questionnaire (STAB)

Time Frame

Change from baseline in STAB at 12 months (at the end of therapy)

Title

Subtypes of Antisocial Behaviour Questionnaire (STAB)

Time Frame

Change from baseline in STAB at 18 months (follow-up)

Title

Reactive-Proactive-Aggression Questionnaire (RPQ)

Time Frame

Change from baseline in RPQ at 6 months

Title

Reactive-Proactive-Aggression Questionnaire (RPQ)

Time Frame

Change from baseline in RPQ at 12 months (at the end of therapy)

Title

Reactive-Proactive-Aggression Questionnaire (RPQ)

Time Frame

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

Secondary Outcome Measure Information:

Title

Global Assessment of Functioning (GAF)

Time Frame

Change from baseline in GAF at 12 months (at the end of therapy)

Title

Clinical Global Impression (CGI-SI)

Time Frame

Change from baseline in CGI-SI at 12 months (at the end of therapy)

Title

Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)

Time Frame

Change from baseline in LoPF-QA at 12 months (at the end of therapy)

Title

Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)

Time Frame

Change from baseline in LoPF-QA at 18 months (follow-up)

Title

Reflective Functioning Questionnaire (RFQ)

Time Frame

Change from baseline in RFQ at 12 months (at the end of therapy)

Title

Reflective Functioning Questionnaire (RFQ)

Time Frame

Change from baseline in RFQ at 18 months (follow-up)

Title

Movie for the Assessment of Social Cognition (MASC)

Time Frame

Change from baseline in MASC at 12 months (at the end of therapy)

Title

10 round Trust Game Task (TGT)

Time Frame

Change from baseline in TGT at 12 months (at the end of therapy)

Title

Social Hierarchy Task (SHT)

Time Frame

Change from baseline in SHT at 12 months (at the end of therapy)

Title

Approach-Avoidance Task (AAT)

Time Frame

Change from baseline in AAT at 12 months (at the end of therapy)

Title

Symptom Checklist-90-Revised (SCL-90R)

Time Frame

Change from baseline in SCL-90R at 12 months (at the end of therapy)

Title

Stress Index for Parents of Adolescents (SIPA)

Time Frame

Change from baseline in SIPA at 12 months (at the end of therapy)

Title

Stress Index for Parents of Adolescents (SIPA)

Time Frame

Change from baseline in SIPA at 18 months (follow-up)

Title

drop-out rates

Time Frame

after 12 months (at the end of therapy)

Title

cost-effectiveness

Description

Cost-effectiveness will be measured by participation in training/school, rehospitalization, internment

Time Frame

after 12 months (at the end of therapy)

Other Pre-specified Outcome Measures:

Title

Working Alliance Inventory (WAI)

Description