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AggressionNCT02485587

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

A study testing Individualized Arousal-Biofeedback and Treatment as usual in people with Aggression and Conduct Disorder, run by Central Institute of Mental Health, Mannheim at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 14 yearsHealthy volunteers can take part
What is being tested?
Individualized Arousal-Biofeedback and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesin 2 countries
Study dates
Sep 2015to Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

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 8 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site
  • Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health

    Mannheim, 68159

Other trials in Germany

Switzerland1 site
  • Department of Child and Adolescent Psychiatry

    Zurich, CH-8032

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Being tested
Individualized Arousal-Biofeedback, Treatment as usual
Keywords
Arousal Biofeedback, Electrodermal activity
Medical subject headings
Aggression, Conduct Disorder, Oppositional Defiant Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized Arousal-BiofeedbackBehavioural

    biofeedback of biological measures of arousal (electrodermal activity)

  • Treatment as usualBehavioural

    counseling, psychoeducation

Study groups in NCT02485587
Study groupRoleWhat they receive
Individualized Arousal-BiofeedbackExperimentalAfter 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).
Receives: Behavioral: Individualized Arousal-Biofeedback
Treatment as usualActive comparatorAfter 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).
Receives: Behavioral: Treatment as usual
Typically developing (TD) control groupNo interventionHealthy, typically developing children will only undergo baseline assessment (observational) for comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Parents or caregivers report on type and intensity of aggressive behavior over the last week (questionnaire)

    Measured: Baseline, evaluation after 10 weeks of treatment, post treatment assessment (20 weeks after the beginning of the training), follow up at 6 months

Secondary outcomes (3)
  1. Changes in brain activation as assessed by fMRI from baseline after 20 weeks

    • 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

    Measured: Baseline and post treatment assessment (20 weeks after the beginning of the training)

  2. Changes in composition of neurotransmitter metabolites as assessed by MRS from baseline after 20 weeks

    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)

    Measured: Baseline and post treatment assessment (20 weeks after the beginning of the training)

  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)

    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)

    Measured: Baseline, post treatment assessment at 20 weeks and follow up at 6 months after the beginning of the training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionOct 2018
  4. Study completionMar 2019

Resources

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
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02485587
Sponsor's protocol ID
EU Health-F2-2013-602805
Status last verified
Apr 2020
First submitted
22 Jun 2015
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Individualized Arousal-Biofeedback and Treatment as usual in people with Aggression and Conduct Disorder, run by Central Institute of Mental Health, Mannheim at 2 sites in 2 countries.

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 6 inclusion and 4 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: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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