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

Not Applicable

Completed

• Conditions: Conduct Disorder
• Interventions: Other: MBT-CD

• Registration Number: NCT02988453
• Lead Sponsor: Heidelberg University

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).

Study Timeline

• Study First Submitted: 2016-11-30
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-09
• Primary Completion: 2021-10
• Study Completion: 2021-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBT-CD	MBT-CD	Mentalization-based treatment program

Primary Outcome Measures

Name	Time	Method
Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II)	Change from baseline in SCID-II at 12 months (at the end of therapy)
Subtypes of Antisocial Behaviour Questionnaire (STAB)	Change from baseline in STAB at 18 months (follow-up)
Reactive-Proactive-Aggression Questionnaire (RPQ)	Change from baseline in RPQ at 18 months (follow-up)

Secondary Outcome Measures

Name	Time	Method
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)	Cost-effectiveness will be measured by participation in training/school, rehospitalization, internment
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)

Trial Locations

Locations (1)

Heidelberg University; 🇩🇪 Heidelberg, Germany