NCT02988453

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)"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

4.8 years

First QC Date

November 30, 2016

Last Update Submit

May 17, 2022

Conditions

Keywords

mentalization-based treatmentconduct disorderadolescents

Outcome Measures

Primary Outcomes (7)

  • 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 6 months

  • Subtypes of Antisocial Behaviour Questionnaire (STAB)

    Change from baseline in STAB 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 6 months

  • Reactive-Proactive-Aggression Questionnaire (RPQ)

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

  • Reactive-Proactive-Aggression Questionnaire (RPQ)

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

Secondary Outcomes (15)

  • Global Assessment of Functioning (GAF)

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

  • Clinical Global Impression (CGI-SI)

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

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

    Change from baseline in LoPF-QA 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)

  • Reflective Functioning Questionnaire (RFQ)

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

  • +10 more secondary outcomes

Other Outcomes (11)

  • Working Alliance Inventory (WAI)

    Change from baseline in WAI at 6 months

  • Working Alliance Inventory (WAI)

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

  • Experiences in Close Relationships - Revised (ECR-R)

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

  • +8 more other outcomes

Study Arms (1)

MBT-CD

EXPERIMENTAL

Mentalization-based treatment program

Other: MBT-CD

Interventions

MBT-CDOTHER

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.

MBT-CD

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • main diagnosis conduct disorder (DSM-5 312.81,312.82)
  • written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg University

Heidelberg, 69115, Germany

Location

Related Publications (6)

  • Taubner S, Zimmermann L, Ramberg A, Schroder P. Mentalization Mediates the Relationship between Early Maltreatment and Potential for Violence in Adolescence. Psychopathology. 2016;49(4):236-246. doi: 10.1159/000448053. Epub 2016 Aug 23.

    PMID: 27548462BACKGROUND
  • 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.

    PMID: 23200287BACKGROUND
  • 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.

    PMID: 23512713BACKGROUND
  • 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.

    BACKGROUND
  • Hauschild S, Kasper L, Volkert J, Sobanski E, Taubner S. Mentalization-based treatment for adolescents with conduct disorder (MBT-CD): a feasibility study. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2611-2622. doi: 10.1007/s00787-022-02113-4. Epub 2022 Nov 25.

  • Taubner S, Hauschild S, Kasper L, Kaess M, Sobanski E, Gablonski TC, Schroder-Pfeifer P, Volkert J. Mentalization-based treatment for adolescents with conduct disorder (MBT-CD): protocol of a feasibility and pilot study. Pilot Feasibility Stud. 2021 Jul 2;7(1):139. doi: 10.1186/s40814-021-00876-2.

MeSH Terms

Conditions

Conduct Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Svenja Taubner, Prof.

    Institute for Psychosocial Prevention, Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 9, 2016

Study Start

December 1, 2016

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations