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Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT02485587
Recruitment Status : Recruiting
First Posted : June 30, 2015
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Brief Summary:
The purpose of this study is to determine whether individualized biofeedback of arousal (skin conductance) is effective in the treatment of aggressive behavior problems in children and adolescents with either predominantly impulsive (reactive) and/or high callous unemotional traits (proactive) subtypes of aggression when compared to treatment as usual (TAU), and induces normalization when compared to a group of typically developing children receiving no intervention.

Condition or disease Intervention/treatment Phase
Aggression Conduct Disorder Oppositional Defiant Disorder Behavioral: Individualized Arousal-Biofeedback Behavioral: Treatment as usual Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents (Part of EC FP7 Project Aggressotype: Aggression Subtyping for Improved Insight and Treatment Innovation in Psychiatric Disorders)
Study Start Date : September 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Individualized Arousal-Biofeedback

After a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the experimental condition will receive 20 sessions of arousal (electrodermal activity) feedback, 1 session/week. Each session will last about 1 hour. After the first 10 sessions (10 weeks after the beginning of the training phase), parents/caregivers will be asked to evaluate behavioral measures of aggression.

After training completion (approximately 20 weeks after the beginning of the training phase), subjects will undergo post-treatment assessment (week 20/21) and follow up (6 months after the end of the training phase).

Behavioral: Individualized Arousal-Biofeedback
biofeedback of biological measures of arousal (electrodermal activity)

Active Comparator: Treatment as usual
After a pre-training assessment at baseline, subjects will be randomized to either treatment arm or treatment as usual. Subjects in the comparator condition will receive several appointments together with their parents/caregivers or group trainings over a timeframe of 20 weeks. Within the sessions, the investigators will focus on psychoeducational issues and provide general counseling for the families. After 10 weeks, parents/caregivers will be asked to evaluate behavioral measures of aggression. After 20 weeks, subjects will undergo post-treatment assessment (week 20/21) and follow up (6 months after the end of the treatment phase).
Behavioral: Treatment as usual
counseling, psychoeducation

No Intervention: Typically developing (TD) control group
Healthy, typically developing children will only undergo baseline assessment (observational) for comparison



Primary Outcome Measures :
  1. Changes in aggressive behavior from baseline at 10 weeks, 20 weeks and at follow up after 6 months as assessed by the Modified Overt Aggression Scale (MOAS) [ Time Frame: Baseline, evaluation after 10 weeks of treatment, post treatment assessment (20 weeks after the beginning of the training), follow up at 6 months ]
    Parents or caregivers report on type and intensity of aggressive behavior over the last week (questionnaire)


Secondary Outcome Measures :
  1. Changes in brain activation as assessed by fMRI from baseline after 20 weeks [ Time Frame: Baseline and post treatment assessment (20 weeks after the beginning of the training) ]
    • At pre-treatment assessment and at the end of the treatment phase, patients will perform 3 tasks during functional magnetic resonance imaging (fMRI). The tasks used are: Passive Avoidance task, Emotional Faces task, Stop-Signal task

  2. Changes in composition of neurotransmitter metabolites as assessed by MRS from baseline after 20 weeks [ Time Frame: Baseline and post treatment assessment (20 weeks after the beginning of the training) ]
    At pre-treatment assessment and at the end of the treatment phase, patients will undergo magnetic resonance spectroscopy (MRS) of two brain areas implicated in inhibitory control (ACC and insula)

  3. Changes in aggressive behavior from baseline after 20 weeks and at follow up after 6 months as assessed by teachers through the aggressive behavior subscale of theTRF (Teachers Report Form) [ Time Frame: Baseline, post treatment assessment at 20 weeks and follow up at 6 months after the beginning of the training ]
    At pre-treatment assessment, after the end of the treatment phase and at follow up, teachers will be asked to complete the TRF, which is a questionnaire focusing on general psychopathology (and allows to differentiate between several subsets of symptoms, amongst others those indicating externalizing and aggressive behavior)



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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (interventional group):

  • ODD/CD diagnosis based on the DSM-5 criteria
  • aggression in the clinical range, T > 70 on the aggression or delinquency subscale of the Teacher Report Form (TRF), Youth Self Report (YSR) or Child Behaviour Checklist (CBCL)
  • Preferably medication-naive, otherwise medication should be stable for at least 2 months

Inclusion Criteria (typically developing (TD) control group):

  • No diagnosis based on the DSM-5 criteria
  • aggression below clinical range, T < 70 on the aggression or delinquency subscale of the Teacher Report Form (TRF), Youth Self Report (YSR) or Child Behaviour Checklist (CBCL)

Exclusion Criteria (both groups):

  • IQ<80
  • a primary DSM-5 diagnosis of psychosis, bipolar disorder, depression or anxiety
  • contra-indications for MRI scanning, e.g. presence of metal parts in the body
  • epilepsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485587


Contacts
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Contact: Nathalie E Holz, PhD 004962117034904 nathalie.holz@zi-mannheim.de
Contact: Sarah Hohmann, MD 004962117034533 sarah.hohmann@zi-mannheim.de

Locations
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Germany
Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health Recruiting
Mannheim, Germany, 68159
Switzerland
Department of Child and Adolescent Psychiatry Recruiting
Zürich, Switzerland, CH-8032
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
University of Zurich
Investigators
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Principal Investigator: Daniel Brandeis, PhD Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health
Principal Investigator: Tobias Banaschewski, MD, PhD Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health

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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT02485587     History of Changes
Other Study ID Numbers: EU Health-F2-2013-602805
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Keywords provided by Central Institute of Mental Health, Mannheim:
Arousal Biofeedback
Electrodermal activity
Additional relevant MeSH terms:
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Disease
Aggression
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Behavioral Symptoms
Neurodevelopmental Disorders
Mental Disorders