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

NCT02485587 | Completed DMC

• 1 other identifier: EU Health-F2-2013-602805
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

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.

Conditions

Aggression; Conduct Disorder; Oppositional Defiant Disorder

Keywords

Arousal Biofeedback; Electrodermal activity

Outcome Measures

Primary Outcomes (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)

  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)

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

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

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

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

• 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)

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

Study Arms (3)

Individualized Arousal-Biofeedback

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

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

Typically developing (TD) control group

NO INTERVENTION

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

Interventions

Individualized Arousal-Biofeedback BEHAVIORAL

biofeedback of biological measures of arousal (electrodermal activity)

Individualized Arousal-Biofeedback

Treatment as usual BEHAVIORAL

counseling, psychoeducation

Treatment as usual

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• University of Zurich: collaborator

Study Sites (2)

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

Mannheim, 68159, Germany

Location

Department of Child and Adolescent Psychiatry

Zurich, CH-8032, Switzerland

Location

MeSH Terms

Conditions

Aggression; Conduct Disorder; Oppositional Defiant Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 30, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

DE (1); CH (1)