Not yet recruitingNAINTERVENTIONAL

Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders?

This research study is investigating if a special type of talking therapy, called Mentalization-Based Therapy (MBT), is more effective than standard care for young people aged 12 to 19. These young people are experiencing significant challenges with their behaviour, often known as Oppositional Defiant Disorder or Conduct Disorder. MBT helps people to understand their own thoughts and feelings, and those of others, which can help explain why they act in certain ways. The study will compare MBT with an enhanced version of regular care, which includes psychiatric support for the young person and training for their parents. The main goal is to find out which approach is better at helping these teenagers manage their behaviour and improve their overall well-being.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

Start

01 Oct 2025

Estimated completion

31 Aug 2028

Conduct Disorders in Adolescence Oppositional Defiant Disorder

What is this study about?

This study is designed to help us understand the best ways to support young people aged 12 to 19 who are facing tough challenges with their behaviour. These challenges can include having serious difficulties following rules, being disruptive, or engaging in acts that get them into trouble. Doctors might refer to these conditions as Oppositional Defiant Disorder (ODD) or Conduct Disorder.

The researchers want to see if a specific type of talking therapy, called Mentalization-Based Therapy (MBT), can make a real difference. MBT helps young people to 'mentalize' – which means learning to think about and understand their own thoughts, feelings, and intentions, as well as those of other people. The idea is that by understanding why we and others do what we do, we can make better choices and have healthier relationships. This study will compare MBT to what's called 'treatment-as-usual-plus' (TAU-plus), which is an improved version of the general care these young people would normally receive, including support for the young person and skills training for their parents.

The findings from this study are important because they could help healthcare professionals decide which treatments are most effective for teenagers struggling with these behavioural issues. Ultimately, the goal is to improve the lives of these young people and their families by finding therapies that truly work and help them thrive.

Key takeaways

It's for teenagers (12-19) with challenging behaviours like ODD or Conduct Disorder.
It compares a special talking therapy (MBT) with an enhanced usual care approach.
MBT helps young people understand thoughts and feelings in themselves and others.
Monthly check-ups will monitor progress and well-being.
Parents also play an active role, with some receiving skills training.
The study aims to find the most effective care for these conditions.

Who may be eligible?

This study is looking for young people aged between 12 and 19 years old. To take part, you must have been diagnosed with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CDD), which are conditions involving significant behavioural concerns.

All participants need to live with their parents, and both the young person and at least one parent must agree to be part of the study and receive the treatment. This includes giving written permission to join.

However, some conditions would mean you couldn't join. This includes if you have serious drug or alcohol dependence that needs hospital care, if you're experiencing severe mental health issues like psychosis, or if you have certain brain conditions or learning difficulties (like an IQ below 80). You also need to be able to speak German well enough to understand the therapy, and there shouldn't be other reasons that make outpatient talking therapy unsuitable for you, such as immediately life-threatening concerns.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 12 and 19 years old?
Have you been diagnosed with Oppositional Defiant Disorder or Conduct Disorder?
Do you live with your parents?
Are you able to speak German well enough for therapy?
Do you *not* have severe drug addiction needing hospital care, serious psychosis, or a learning disability (IQ below 80)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your participation will begin by being randomly assigned to one of two groups: either the Mentalization-Based Therapy (MBT) group or the enhanced usual care (TAU-plus) group. Being 'randomly assigned' means it's like a fair coin flip, so neither you nor the researchers choose which group you're in. This helps make the study fair.

During the study, you'll have monthly check-ups where you'll be asked questions about your thoughts, feelings, how you're coping, your experiences with therapy, and how much you trust other people. These are important for understanding how the treatments are working. You will also be asked to complete questionnaires about your well-being, feelings, and qualities of your personality. Some information will also be gathered through interviews with you about your behaviour and personality.

Your parents will also be actively involved, especially if you are in the TAU-plus group, as they will receive emotion-focused skills training. The total duration of your participation will depend on how the study is set up, but it will involve these assessments and therapy over a period of time.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be an improvement in managing your behaviour, feeling better about yourself, and having better relationships, especially if one of the therapies proves to be very effective for you. You will also receive either a specialized talking therapy or enhanced standard care. Potential risks are generally low, but it's possible that thinking and talking about difficult emotions and behaviours could sometimes feel challenging or upsetting. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Institut für Psychosoziale Prävention, Ruprecht-Karls-Universität Heidelberg
Verified postcode
Heidelberg, Germany

Common questions

What is 'Mentalization-Based Therapy'?

It's a type of talking therapy that helps you understand your own thoughts and feelings, and those of others, to make sense of why people act the way they do.

What are 'Oppositional Defiant Disorder' and 'Conduct Disorder'?

These are names for persistent difficulties young people have with following rules, managing their anger, and sometimes engaging in serious misbehaviour.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two treatment groups. This is like drawing names from a hat to keep the study fair.

How long will I be in the study?

The information doesn't state an exact length, but it will involve ongoing therapy sessions and monthly check-ups over a period of time.

Who can get involved in this study?

Teenagers aged 12-19 with a diagnosis of Oppositional Defiant Disorder or Conduct Disorder, who live with their parents and meet other specific health requirements.

How to find out more

Meike M. Hurrle, Dipl.-Psych.

meike.hurrle@med.uni-heidelberg.de +496221 56-39528 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.