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Completed

NCT Number: NCT02988453

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

A feasibility and pilot trial to investigate the feasibility of a newly manualized psychotherapy "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)"

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Key information

Conditions

Conduct Disorder Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heidelberg University

Heidelberg, 69115, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MBT-CD

Other

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 outcomes

  1. 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)

  2. Subtypes of Antisocial Behaviour Questionnaire (STAB)

    Time frame: Change from baseline in STAB at 6 months

  3. Subtypes of Antisocial Behaviour Questionnaire (STAB)

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

  4. Subtypes of Antisocial Behaviour Questionnaire (STAB)

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

  5. Reactive-Proactive-Aggression Questionnaire (RPQ)

    Time frame: Change from baseline in RPQ at 6 months

  6. Reactive-Proactive-Aggression Questionnaire (RPQ)

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

  7. Reactive-Proactive-Aggression Questionnaire (RPQ)

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

Secondary outcomes

  1. Global Assessment of Functioning (GAF)

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

  2. Clinical Global Impression (CGI-SI)

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

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

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

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

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

  5. Reflective Functioning Questionnaire (RFQ)

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

  6. Reflective Functioning Questionnaire (RFQ)

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

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

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

  8. 10 round Trust Game Task (TGT)

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

  9. Social Hierarchy Task (SHT)

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

  10. Approach-Avoidance Task (AAT)

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

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

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

  12. Stress Index for Parents of Adolescents (SIPA)

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

  13. Stress Index for Parents of Adolescents (SIPA)

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

  14. drop-out rates

    Time frame: after 12 months (at the end of therapy)

  15. cost-effectiveness

    Time frame: after 12 months (at the end of therapy)

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

Other outcomes

  1. Working Alliance Inventory (WAI)

    Time frame: Change from baseline in WAI at 6 months

    Treatment related variable (moderator)

  2. Working Alliance Inventory (WAI)

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

    Treatment related variable (moderator)

  3. Experiences in Close Relationships - Revised (ECR-R)

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

    Treatment related variable (moderator)

  4. Emotion Regulation Questionnaire (ERQ)

    Time frame: Change from baseline in ERQ at 12 months (at the end of therapy)

    Treatment related variable (moderator)

  5. Emotion Regulation Questionnaire (ERQ)

    Time frame: Change from baseline in ERQ at 18 months (follow-up)

    Treatment related variable (moderator)

  6. Zurich Brief Questionnaire for the Assessment of Parental Behaviors (ZKE)

    Time frame: Change from baseline in ZKE at 12 months (at the end of therapy)

    Treatment related variable (moderator)

  7. The Mini-International Neuropsychiatric Interview (MINI)

    Time frame: Change from baseline in MINI at 12 months (at the end of therapy)

    Treatment related variable (moderator)

  8. Youth Psychopathy Traits Inventory (YPI)

    Time frame: only baseline assessment

    Treatment related variable (moderator)

  9. Cultural-Fair-Test (CFT-2)

    Time frame: only baseline assessment

    Treatment related variable (moderator)

  10. Childhood Experience of Care and Abuse Questionnaire (CECA-Q)

    Time frame: only baseline assessment

    Treatment related variable (moderator)

  11. Dimensional Assessment of Personality Pathology - Basic Questionnaire (DAPP-BQ)

    Time frame: only baseline assessment

    Treatment related variable (moderator)

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MBT-CD

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2016
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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