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Conduct DisorderMBT-CDNCT02988453

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

A study testing MBT-CD in people with Conduct Disorder, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)" Read more about this study

Who is it for?
Ages 11 to 18 years
Conditions the study is for
Conduct Disorder
What is being tested?
MBT-CD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteGermany
Study dates
Dec 2016to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Heidelberg University

    Heidelberg, 69115

Other trials in Germany

About this study

Official title: 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)"

Read the 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).

Being tested
MBT-CD
Keywords
mentalization-based treatment, conduct disorder, adolescents
Medical subject headings
Conduct Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02988453
Study groupRoleWhat they receive
MBT-CDExperimentalMentalization-based treatment program
Receives: Other: MBT-CD

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Change from baseline in SCID-II at 12 months (at the end of therapy)

  2. Subtypes of Antisocial Behaviour Questionnaire (STAB)

    Measured: Change from baseline in STAB at 6 months

  3. Subtypes of Antisocial Behaviour Questionnaire (STAB)

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

  4. Subtypes of Antisocial Behaviour Questionnaire (STAB)

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

  5. Reactive-Proactive-Aggression Questionnaire (RPQ)

    Measured: Change from baseline in RPQ at 6 months

  6. Reactive-Proactive-Aggression Questionnaire (RPQ)

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

  7. Reactive-Proactive-Aggression Questionnaire (RPQ)

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

Secondary outcomes (15)

  1. Global Assessment of Functioning (GAF)

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

  2. Clinical Global Impression (CGI-SI)

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

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

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

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

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

  5. Reflective Functioning Questionnaire (RFQ)

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

  6. Reflective Functioning Questionnaire (RFQ)

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

  7. Movie for the Assessment of Social Cognition (MASC)

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

  8. 10 round Trust Game Task (TGT)

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

  9. Social Hierarchy Task (SHT)

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

  10. Approach-Avoidance Task (AAT)

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

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

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

  12. Stress Index for Parents of Adolescents (SIPA)

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

  13. Stress Index for Parents of Adolescents (SIPA)

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

  14. drop-out rates

    Measured: after 12 months (at the end of therapy)

  15. cost-effectiveness

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

    Measured: after 12 months (at the end of therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionOct 2021
  4. Study completionDec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02988453
Sponsor's protocol ID
23011229
Acronym
MBT-CD
Status last verified
May 2022
First submitted
30 Nov 2016
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27548462

  • 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.

    PubMed 23200287

  • 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.

    PubMed 23512713

  • 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.

  • 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.

    PubMed 36434148

  • 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.

    PubMed 34215323

Questions about this trial

What is this clinical trial studying?

A study testing MBT-CD in people with Conduct Disorder, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02988453, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 3 Nov 2026.

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