Conduct Disorders in AdolescenceMEDALNCT07181928
Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders?
A study testing Mentalization-Based Therapy (MBT) and Treatment-as-usual-plus (TAU-plus) in people with Conduct Disorders in Adolescence and Oppositional Defiant Disorder, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The goal of this clinical trial is to investigate if Mentalization-based therapy (MBT) is superior to enhanced usual care (treatment-as-usual-plus (TAU-plus)) for adolescents with disruptive behavior or dissocial disorders. MBT is an intervention that aims to improve mentalizing. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Conduct Disorders in Adolescence, Oppositional Defiant Disorder
- What is being tested?
- Mentalization-Based Therapy (MBT) and Treatment-as-usual-plus (TAU-plus)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary diagnosis of Oppositional defiant disorder (ODD) / Conduct-dissocial disorder (CDD) (ICD-11: 6C90-6C91; ICD-10: F91.0-F91.9; DSM-5: 312.81, 313.81)
- Aged 12 to 19 years
- Living with their parents
- Provide written informed consent (plus parental consent for minors)
- At least one parent provides written informed consent and agrees to active participation in treatment and study, including randomization
Who cannot join
- Severe acute substance dependence requiring inpatient detoxification
- Acute psychotic symptoms or early-onset schizophrenia
- Neurological impairments or intellectual disability (IQ < 80)
- Insufficient proficiency in German
- Other clinical contraindications for outpatient psychotherapy (e.g., acute suicidality)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg
Heidelberg, Baden-Wurttemberg, 69115
Dipl.-Psych. Meike Hurrle, +496221 56-39528, Meike.Hurrle@med.uni-heidelberg.de
About this study
Official title: Is Mentalization-based Therapy More Effective for Adolescents With Disruptive and Dissocial Disorders Than TAU-plus (Emotion-focused Parent Training With Supportive Child Psychiatric Care)?
The goal of this clinical trial is to investigate if Mentalization-based therapy (MBT) is superior to enhanced usual care (treatment-as-usual-plus (TAU-plus)) for adolescents with disruptive behavior or dissocial disorders.
MBT is an intervention that aims to improve mentalizing. Mentalizing is the ability to reflect on mental states in oneself and others that motivate behavior. TAU-plus consists of psychiatric care for the adolescent, along with additional emotion-focused skills training for the parents.
Participants will be randomized in one of two groups using one study center.
Read the detailed description
The study includes adolescents between the ages 12 to 19 of any gender who have been diagnosed with Oppositional defiant or Conduct-dissocial disorder (serious problems with following rules or criminal behavior).
The diagnosis is the primary outcome, which is assessed based on a diagnostic interview. Secondary outcomes include antisocial behavior, quality of life, symptom burden, and personality functioning (measured through self-report questionnaires), as well as aggressive behavior (measured through interview).
During the study, there will be monthly process assessments. In these assessments, participants will be asked questions about mentalizing, emotion regulation, therapy experience, antisocial behavior, and how much they trust others. These variables are considered mediators of changes in outcome.
Participants will also be interviewed regarding personality functioning to investigate whether dissocial disorders are related to personality disorders.
- Being tested
- Mentalization-Based Therapy (MBT), Treatment-as-usual-plus (TAU-plus)
- Keywords
- Adolescence, MBT, Conduct Disorder, Externalizing behaviour disorders, Treatment-as-usual
- Medical subject headings
- Oppositional Defiant Disorder, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization-Based Therapy (MBT)Behavioural
MBT is a manualized psychodynamic therapy based on attachment theory, designed to restore adolescents' mentalizing in general and in emotionally stressful situations and relationships. It targets to rebuilt epistemic trust, to successfully mentalize oneself and others.
Treatment-as-usual-plus (TAU-plus)Behavioural
The adolescents receive supportive child psychiatric consultations. For the parents the EFST sessions combine mindfulness, theoretical input, and experiential practice. Parents learn and apply four core skills: validation, repair, motivation, and setting boundaries.
| Study group | Role | What they receive |
|---|---|---|
| Mentalization-Based Therapy (MBT) | Experimental | 45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive MBT over 10 months. The patients have 30 individual sessions weekly conducted by one therapist with formal training in MBT. Additionally, the patient receives 5 sessions together with the parents and the parents will have another 5 sessions without the patient. Receives: Behavioral: Mentalization-Based Therapy (MBT) |
| Treatment-as-usual-plus (TAU-plus) | Active comparator | 45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive standard psychiatric care over 10 months and their parents will participate in the Emotion Focused Skills Training (EFST). The patient receives individual psychiatric sessions at least two per quarter depending on the adolescent's needs. The individual sessions are conducted by a child and adolescent psychiatrist and/or by a therapist working under their supervision. EFST includes an intake session, 5 two-hour group sessions (6-12 parents, led by two therapists), and a final individual session. Receives: Behavioral: Treatment-as-usual-plus (TAU-plus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders
Remission is defined as the proportion of participants no longer meeting full diagnostic criteria for Conduct-dissocial disorder (CDD) or Oppositional defiant disorder (ODD). CDD is assessed with the "Diagnostisches Interview bei psychischen Störungen - Version für Jugendlichen" (J-DIPS) and ODD with the "Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter" (K-DIPS).
Measured: Day 0, Month 14
Secondary outcomes (7)
Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D)
Score range: 0 - 300, with higher score representing higher value of aggressive behavior
Measured: day 0, month 11 month 14
Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB)
Score range 11 - 55, with higher score representing higher value of Social aggression
Measured: day 0 month 11 and month 14
Quality of life assessed with the Kidscreen 10 Index
Score range: 10-50, with higher scores representing better quality of life
Measured: day 0, month 11, month 14
Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ)
Score range: 0 - 40, with higher score representing higher value of difficulties or strengths respectively
Measured: day 0, month 11, month 14
Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP)
Score range: 0 - 7, with higher score represeting higher value of overall capacity level
Measured: day 0, month 14
Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG)
There are four subscales - femenine positive and negative and Masculine positive and negative. Score range for each subscale: 1-5, with high scores indicate a high expression of the respective facet of the gender role self-concept.
Measured: day 0, month 14
Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF)
Score range: 12-48, with higher score representing higher value of personality pathology
Measured: day 0, month 11, month 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Conduct Disorders in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie
- Responsible party
- Principal investigator, Svenja Taubner, University Hospital Heidelberg
- Investigators
- Svenja Taubner, Prof. Dr., Study director, Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181928
- Sponsor's protocol ID
- Tau 2025 1/2
- Acronym
- MEDAL
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is too sensitive
Publications
Korlat S, Holzer J, Schultes MT, Buerger S, Schober B, Spiel C, Kollmayer M. Benefits of Psychological Androgyny in Adolescence: The Role of Gender Role Self-Concept in School-Related Well-Being. Front Psychol. 2022 May 19;13:856758. doi: 10.3389/fpsyg.2022.856758. eCollection 2022.
PubMed 35664189Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46. doi: 10.1097/00005053-198809000-00007.
PubMed 3418327Neuschwander M, In-Albon T, Adornetto C, Roth B, Schneider S. [Interrater reliability of the <<Diagnostic Interview bei psychischen Storungen im Kindes- und Jugendalter (Kinder-DIPS)]. Z Kinder Jugendpsychiatr Psychother. 2013 Sep;41(5):319-34. doi: 10.1024/1422-4917//a000247. German.
PubMed 23988834Spitzer C, Muller S, Kerber A, Hutsebaut J, Brahler E, Zimmermann J. [The German Version of the Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF): Latent Structure, Convergent Validity and Norm Values in the General Population]. Psychother Psychosom Med Psychol. 2021 Jul;71(7):284-293. doi: 10.1055/a-1343-2396. Epub 2021 Mar 10. German.
PubMed 33694153Henning A, Linden M, Muschalla B. Self- and observer ratings of capacity limitations in patients with neurological conditions. Brain Impair. 2023 Dec;24(3):586-600. doi: 10.1017/BrImp.2022.26. Epub 2022 Nov 17.
PubMed 38167355Klasen H, Woerner W, Rothenberger A, Goodman R. [German version of the Strength and Difficulties Questionnaire (SDQ-German)--overview and evaluation of initial validation and normative results]. Prax Kinderpsychol Kinderpsychiatr. 2003 Sep;52(7):491-502. German.
PubMed 14526759Ravens-Sieberer U, Herdman M, Devine J, Otto C, Bullinger M, Rose M, Klasen F. The European KIDSCREEN approach to measure quality of life and well-being in children: development, current application, and future advances. Qual Life Res. 2014 Apr;23(3):791-803. doi: 10.1007/s11136-013-0428-3. Epub 2013 May 18.
PubMed 23686556Burt SA, Donnellan MB. Development and validation of the Subtypes of Antisocial Behavior Questionnaire. Aggress Behav. 2009 Sep-Oct;35(5):376-98. doi: 10.1002/ab.20314.
PubMed 19618380
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Mentalization-based Therapy More Effective for Adolescents With Disruptive and Dissocial Disorders Than TAU-plus (Emotion-focused Parent Training With Supportive Child Psychiatric Care)?
- ClinicalTrials.gov ID
- NCT07181928
- Acronym / sponsor ID
- MEDAL / Tau 2025 1/2
- Keywords
- Adolescence, MBT, Conduct Disorder, Externalizing behaviour disorders, Treatment-as-usual
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate if Mentalization-based therapy (MBT) is superior to enhanced usual care (treatment-as-usual-plus (TAU-plus)) for adolescents with disruptive behavior or dissocial disorders.
MBT is an intervention that aims to improve mentalizing. Mentalizing is the ability to reflect on mental states in oneself and others that motivate behavior. TAU-plus consists of psychiatric care for the adolescent, along with additional emotion-focused skills training for the parents.
Participants will be randomized in one of two groups using one study center.
Detailed description
The study includes adolescents between the ages 12 to 19 of any gender who have been diagnosed with Oppositional defiant or Conduct-dissocial disorder (serious problems with following rules or criminal behavior).
The diagnosis is the primary outcome, which is assessed based on a diagnostic interview. Secondary outcomes include antisocial behavior, quality of life, symptom burden, and personality functioning (measured through self-report questionnaires), as well as aggressive behavior (measured through interview).
During the study, there will be monthly process assessments. In these assessments, participants will be asked questions about mentalizing, emotion regulation, therapy experience, antisocial behavior, and how much they trust others. These variables are considered mediators of changes in outcome.
Participants will also be interviewed regarding personality functioning to investigate whether dissocial disorders are related to personality disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentalization-Based Therapy (MBT) | Experimental | Behavioral: Mentalization-Based Therapy (MBT)45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive MBT over 10 months. The patients have 30 individual sessions weekly conducted by one therapist with formal training in MBT. Additionally, the patient receives 5 sessions together with the parents and the parents will have another 5 sessions without the patient. |
| Treatment-as-usual-plus (TAU-plus) | Active comparator | Behavioral: Treatment-as-usual-plus (TAU-plus)45 adolescents diagnosed with conduct disorder/oppositional defiant disorder will receive standard psychiatric care over 10 months and their parents will participate in the Emotion Focused Skills Training (EFST). The patient receives individual psychiatric sessions at least two per quarter depending on the adolescent's needs. The individual sessions are conducted by a child and adolescent psychiatrist and/or by a therapist working under their supervision. EFST includes an intake session, 5 two-hour group sessions (6-12 parents, led by two therapists), and a final individual session. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Primary diagnosis of Oppositional defiant disorder (ODD) / Conduct-dissocial disorder (CDD) (ICD-11: 6C90-6C91; ICD-10: F91.0-F91.9; DSM-5: 312.81, 313.81)
- Aged 12 to 19 years
- Living with their parents
- Provide written informed consent (plus parental consent for minors)
- At least one parent provides written informed consent and agrees to active participation in treatment and study, including randomization
Key exclusion criteria (5 listed)
- Severe acute substance dependence requiring inpatient detoxification
- Acute psychotic symptoms or early-onset schizophrenia
- Neurological impairments or intellectual disability (IQ < 80)
- Insufficient proficiency in German
- Other clinical contraindications for outpatient psychotherapy (e.g., acute suicidality)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization-Based Therapy (MBT)MBT is a manualized psychodynamic therapy based on attachment theory, designed to restore adolescents' mentalizing in general and in emotionally stressful situations and relationships. It targets to rebuilt epistemic trust, to successfully mentalize oneself and others. | Behavioural | Mentalization-Based Therapy (MBT) |
| Treatment-as-usual-plus (TAU-plus)The adolescents receive supportive child psychiatric consultations. For the parents the EFST sessions combine mindfulness, theoretical input, and experiential practice. Parents learn and apply four core skills: validation, repair, motivation, and setting boundaries. | Behavioural | Treatment-as-usual-plus (TAU-plus) |
Primary outcome
Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders
Time frame: Day 0, Month 14
Remission is defined as the proportion of participants no longer meeting full diagnostic criteria for Conduct-dissocial disorder (CDD) or Oppositional defiant disorder (ODD). CDD is assessed with the "Diagnostisches Interview bei psychischen Störungen - Version für Jugendlichen" (J-DIPS) and ODD with the "Diagnostisches Interview bei psychischen Störungen im Kindes- und Jugendalter" (K-DIPS).
7 secondary outcomes
Aggressive behavior assessed with the german "Modified Overt Aggression Scale" (MOAS-D)
Time frame: day 0, month 11 month 14
Social aggression assessed with the subscale from Subtypes of Antisocial Behavior Questionnaire (STAB)
Time frame: day 0 month 11 and month 14
Quality of life assessed with the Kidscreen 10 Index
Time frame: day 0, month 11, month 14
Symptom burden assessed with the Strengths and Difficulties Questionnaire (SDQ)
Time frame: day 0, month 11, month 14
Participation assessed with the mini self-rating for psychological activities and participation (Mini-ICF-APP)
Time frame: day 0, month 14
Gender typicality assessed with the "Instrument zur Erfassung des Geschlechtsrollen-Selbstkonzepts im Jugendalter" (GRI-JUG)
Time frame: day 0, month 14
Personality functioning assessed with the Level of Personality Functioning Brief Form (LPFS-BF)
Time frame: day 0, month 11, month 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 35664189Korlat S, Holzer J, Schultes MT, Buerger S, Schober B, Spiel C, Kollmayer M. Benefits of Psychological Androgyny in Adolescence: The Role of Gender Role Self-Concept in School-Related Well-Being. Front Psychol. 2022 May 19;13:856758. doi: 10.3389/fpsyg.2022.856758. eCollection 2022.
- Background: PubMed 3418327Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46. doi: 10.1097/00005053-198809000-00007.
- Background: PubMed 23988834Neuschwander M, In-Albon T, Adornetto C, Roth B, Schneider S. [Interrater reliability of the <<Diagnostic Interview bei psychischen Storungen im Kindes- und Jugendalter (Kinder-DIPS)]. Z Kinder Jugendpsychiatr Psychother. 2013 Sep;41(5):319-34. doi: 10.1024/1422-4917//a000247. German.
- Background: PubMed 33694153Spitzer C, Muller S, Kerber A, Hutsebaut J, Brahler E, Zimmermann J. [The German Version of the Level of Personality Functioning Scale-Brief Form 2.0 (LPFS-BF): Latent Structure, Convergent Validity and Norm Values in the General Population]. Psychother Psychosom Med Psychol. 2021 Jul;71(7):284-293. doi: 10.1055/a-1343-2396. Epub 2021 Mar 10. German.
- Background: PubMed 38167355Henning A, Linden M, Muschalla B. Self- and observer ratings of capacity limitations in patients with neurological conditions. Brain Impair. 2023 Dec;24(3):586-600. doi: 10.1017/BrImp.2022.26. Epub 2022 Nov 17.
- Background: PubMed 14526759Klasen H, Woerner W, Rothenberger A, Goodman R. [German version of the Strength and Difficulties Questionnaire (SDQ-German)--overview and evaluation of initial validation and normative results]. Prax Kinderpsychol Kinderpsychiatr. 2003 Sep;52(7):491-502. German.
- Background: PubMed 23686556Ravens-Sieberer U, Herdman M, Devine J, Otto C, Bullinger M, Rose M, Klasen F. The European KIDSCREEN approach to measure quality of life and well-being in children: development, current application, and future advances. Qual Life Res. 2014 Apr;23(3):791-803. doi: 10.1007/s11136-013-0428-3. Epub 2013 May 18.
- Background: PubMed 19618380Burt SA, Donnellan MB. Development and validation of the Subtypes of Antisocial Behavior Questionnaire. Aggress Behav. 2009 Sep-Oct;35(5):376-98. doi: 10.1002/ab.20314.
- Individual participant dataSharing planned: No. Data is too sensitive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Svenja Taubner, Prof. Dr. study director
Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization-Based Therapy (MBT) and Treatment-as-usual-plus (TAU-plus) in people with Conduct Disorders in Adolescence and Oppositional Defiant Disorder, run by University Hospital Heidelberg 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meike M. Hurrle, Dipl.-Psych. (+496221 56-39528, Meike.Hurrle@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate based on diagnostic criteria for Disruptive behavior or Dissocial disorders (time frame: Day 0, Month 14). 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 NCT07181928, which also lists 8 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 Sep 2025.