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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-19
SponsorUniversity Hospital Heidelberg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mentalization-Based Therapy (MBT)

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Mentalization-Based Therapy (MBT)Experimental treatment 1 intervention
Group B: Treatment-as-usual-plus (TAU-plus)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Day 0, Month 14

Secondary outcomes

1

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

Time frame
day 0, month 11 month 14
2

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

Time frame
day 0 month 11 and month 14
3

Quality of life assessed with the Kidscreen 10 Index

Score range: 10-50, with higher scores representing better quality of life

Time frame
day 0, month 11, month 14
4

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

Time frame
day 0, month 11, month 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Heidelberg

Lead sponsor

Vereinigung für analytische und tiefenpsychologisch fundierte Kinder- & Jugendlichen- Psychotherapie

Collaborator

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