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

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Brief Title

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

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)

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.
    

Detailed Description

      In this study, which is part of the EC FP7 projects Aggressotype
      (FP7-Health-2013-Innovation-1 602805, Aggression subtyping for improved insight and treatment
      innovation in psychiatric disorders), the investigators focus on the testing of an
      innovative, non-pharmacological therapeutic approach for children and adolescents with
      different subtypes of aggressive behavior problems. Participants will be trained to acquire
      control over their arousal as measured by skin conductance/electrodermal activity. As
      aggressive behavior involves a dysregulation of arousal at rest and in response to emotional
      stimuli (lower electrodermal activity and heart rate, differences in EEG), the individualized
      acquisition of self-control over ones arousal level might represent a promising therapeutic
      approach for this kind of disorder.

      While trying to control their arousal level, participants receive direct continuous feedback
      about their physiological state and its changes, and are rewarded for successful
      manipulation, i.e. up- or downregulation. During transfer trials continuous feedback is
      omitted. Biofeedback methods are currently used to treat patients with a variety of
      psychiatric disorders such as ADHD.

      The investigators would like to focus on the following questions concerning the effectiveness
      of this treatment approach:

        1. Can participants gain increasing control over their arousal level through biofeedback
           training of electrodermal activity?

        2. Which short- and longer term consequences can be expected from improved self-control
           over physiological measures of arousal upon aggressive and antisocial behavior problems?

      Before the training, all subjects will undergo an extensive pre-treatment assessment as part
      of the characterization and subtyping of aggression within the large multicenter subtyping
      studies (EU-Aggressotype and EU-MATRICS). The assessment includes clinical and psychometric
      measures, neuropsychological testing, fMRI (3 tasks + resting state), MRS (2 voxels) and DTI
      as well as biosampling (blood/saliva for genetics/epigenetics/hormones). Comparison with a
      typically developing (TD) control group receiving no intervention will allow to interpret
      changes in terms of normalisation or compensation.

      After completion of this pretest, subjects meeting the inclusion criteria for the
      arousal-biofeedback treatment study will be randomly assigned to two different treatment
      arms, either to the experimental arousal feedback condition or to the comparator condition
      with TAU lasting about 20 weeks. Subjects assigned to the experimental condition will receive
      20 sessions (1/week) of arousal (electrodermal activity)-feedback, learning to either in- or
      decrease levels of electrodermal activity. At the beginning of the first treatment session, a
      baseline assessment of arousal measures will be done in order to determine the arousal
      subtype of the participants (hypo- or hyperarousal), and the main direction of individualized
      training (up- or downregulation). Afterwards, each training will last about 1 hour and
      consist of several experimental blocks, including feedback as well as transfer trials with
      EEG and heart rate recorded simultaneously during the sessions. Video clips of emotional and
      aggressive situations will be used to support regulation of arousal. During the first 10
      sessions, all participants will be asked to increase/decrease their electrodermal activity in
      a proportion of about 2:1 depending on the dominant arousal subtype, in order to train mainly
      upregulation in patients with hypoarousal, and downregulation in patients with hyperarousal.
      Subjects in the comparator TAU arm will receive several sessions of psychoeducation and
      counseling with their parents/caregivers or group training over the 20 weeks.

      After the first 10 sessions of feedback training (or several appointments with their
      parents/caregivers or group trainings in the TAU group) approximately 10 weeks after the
      beginning of the training, parents/caregivers will be asked to shortly evaluate behavioral
      measures of aggressive behavior by filling out the MOAS. In the feedback group arousal
      measures will be reassessed as done at the beginning of the first training to assess
      stability.

      After completion of either the training or the TAU, subjects will undergo post-treatment
      assessment including again the same teachers and parents reports on behavioral measures, as
      well as the neuropsychological testing, fMRI and MRS. A follow-up assessment with parents and
      teachers reports on behavioral measures only will take place 6 months after the end of the
      treatment phase.
    


Study Type

Interventional


Primary Outcome

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)

Secondary Outcome

 Changes in brain activation as assessed by fMRI from baseline after 20 weeks

Condition

Aggression

Intervention

Individualized Arousal-Biofeedback

Study Arms / Comparison Groups

 Individualized Arousal-Biofeedback
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

28

Start Date

September 2015

Completion Date

March 2019

Primary Completion Date

October 2018

Eligibility 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
      

Gender

All

Ages

8 Years - 14 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Daniel Brandeis, PhD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02485587

Organization ID

EU Health-F2-2013-602805


Responsible Party

Sponsor

Study Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

 University of Zurich

Study Sponsor

Daniel Brandeis, PhD, Principal Investigator, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health


Verification Date

April 2020