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

Conduct Disorder Clinical Trial

— MBT-CD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988453
• Other study ID #: 23011229
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: May 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)"

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Conduct Disorder
• Disease

Intervention

Other:
• MBT-CD
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.

Locations

Country	Name	City	State
Germany	Heidelberg University	Heidelberg

Sponsors (4)

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

Country where clinical trial is conducted

Germany, 

References & Publications (4)

McGauley G, Yakeley J, Williams W, Bateman AW. Attachment, mentalization and antisocial personality disorder. The possible contribution of mentalization-based treatment. European Journal of Psychotherapy & Counselling. 2011; 13 (4): 371-393; doi: 10.1080/13642537.2011.629118.

Rossouw TI, Fonagy P. Mentalization-based treatment for self-harm in adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Dec;51(12):1304-1313.e3. doi: 10.1016/j.jaac.2012.09.018. — View Citation

Taubner S, White LO, Zimmermann J, Fonagy P, Nolte T. Attachment-related mentalization moderates the relationship between psychopathic traits and proactive aggression in adolescence. J Abnorm Child Psychol. 2013 Aug;41(6):929-38. doi: 10.1007/s10802-013-9736-x. — View Citation

Taubner S, Zimmermann L, Ramberg A, Schröder P. Mentalization Mediates the Relationship between Early Maltreatment and Potential for Violence in Adolescence. Psychopathology. 2016;49(4):236-246. Epub 2016 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Working Alliance Inventory (WAI)	Treatment related variable (moderator)	Change from baseline in WAI at 6 months
Other	Working Alliance Inventory (WAI)	Treatment related variable (moderator)	Change from baseline in WAI at 12 months (at the end of therapy)
Other	Experiences in Close Relationships - Revised (ECR-R)	Treatment related variable (moderator)	Change from baseline in ECR-R at 12 months (at the end of therapy)
Other	Emotion Regulation Questionnaire (ERQ)	Treatment related variable (moderator)	Change from baseline in ERQ at 12 months (at the end of therapy)
Other	Emotion Regulation Questionnaire (ERQ)	Treatment related variable (moderator)	Change from baseline in ERQ at 18 months (follow-up)
Other	Zurich Brief Questionnaire for the Assessment of Parental Behaviors (ZKE)	Treatment related variable (moderator)	Change from baseline in ZKE at 12 months (at the end of therapy)
Other	The Mini-International Neuropsychiatric Interview (MINI)	Treatment related variable (moderator)	Change from baseline in MINI at 12 months (at the end of therapy)
Other	Youth Psychopathy Traits Inventory (YPI)	Treatment related variable (moderator)	only baseline assessment
Other	Cultural-Fair-Test (CFT-2)	Treatment related variable (moderator)	only baseline assessment
Other	Childhood Experience of Care and Abuse Questionnaire (CECA-Q)	Treatment related variable (moderator)	only baseline assessment
Other	Dimensional Assessment of Personality Pathology - Basic Questionnaire (DAPP-BQ)	Treatment related variable (moderator)	only baseline assessment
Primary	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)
Primary	Subtypes of Antisocial Behaviour Questionnaire (STAB)		Change from baseline in STAB at 6 months
Primary	Subtypes of Antisocial Behaviour Questionnaire (STAB)		Change from baseline in STAB at 12 months (at the end of therapy)
Primary	Subtypes of Antisocial Behaviour Questionnaire (STAB)		Change from baseline in STAB at 18 months (follow-up)
Primary	Reactive-Proactive-Aggression Questionnaire (RPQ)		Change from baseline in RPQ at 6 months
Primary	Reactive-Proactive-Aggression Questionnaire (RPQ)		Change from baseline in RPQ at 12 months (at the end of therapy)
Primary	Reactive-Proactive-Aggression Questionnaire (RPQ)		Change from baseline in RPQ at 18 months (follow-up)
Secondary	Global Assessment of Functioning (GAF)		Change from baseline in GAF at 12 months (at the end of therapy)
Secondary	Clinical Global Impression (CGI-SI)		Change from baseline in CGI-SI at 12 months (at the end of therapy)
Secondary	Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)		Change from baseline in LoPF-QA at 12 months (at the end of therapy)
Secondary	Levels of Personality Functioning - Questionnaire Adolescence (LoPF-QA)		Change from baseline in LoPF-QA at 18 months (follow-up)
Secondary	Reflective Functioning Questionnaire (RFQ)		Change from baseline in RFQ at 12 months (at the end of therapy)
Secondary	Reflective Functioning Questionnaire (RFQ)		Change from baseline in RFQ at 18 months (follow-up)
Secondary	Movie for the Assessment of Social Cognition (MASC)		Change from baseline in MASC at 12 months (at the end of therapy)
Secondary	10 round Trust Game Task (TGT)		Change from baseline in TGT at 12 months (at the end of therapy)
Secondary	Social Hierarchy Task (SHT)		Change from baseline in SHT at 12 months (at the end of therapy)
Secondary	Approach-Avoidance Task (AAT)		Change from baseline in AAT at 12 months (at the end of therapy)
Secondary	Symptom Checklist-90-Revised (SCL-90R)		Change from baseline in SCL-90R at 12 months (at the end of therapy)
Secondary	Stress Index for Parents of Adolescents (SIPA)		Change from baseline in SIPA at 12 months (at the end of therapy)
Secondary	Stress Index for Parents of Adolescents (SIPA)		Change from baseline in SIPA at 18 months (follow-up)
Secondary	drop-out rates		after 12 months (at the end of therapy)
Secondary	cost-effectiveness	Cost-effectiveness will be measured by participation in training/school, rehospitalization, internment	after 12 months (at the end of therapy)