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

NCT ID: NCT02485587

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-03-31

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.

Conditions

Aggression; Conduct Disorder; Oppositional Defiant Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Individualized Arousal-Biofeedback

Intervention Type: BEHAVIORAL

biofeedback of biological measures of arousal (electrodermal activity)

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).

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

counseling, psychoeducation

Typically developing (TD) control group

Healthy, typically developing children will only undergo baseline assessment (observational) for comparison

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individualized Arousal-Biofeedback

biofeedback of biological measures of arousal (electrodermal activity)

Intervention Type: BEHAVIORAL

Treatment as usual

counseling, psychoeducation

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Brandeis, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Tobias Banaschewski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Mannheim, , Germany

Department of Child and Adolescent Psychiatry

Zurich, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

EU Health-F2-2013-602805

Identifier Type: -

Identifier Source: org_study_id