Real-time fMRI for the Treatment of Aggressive Behavior in Adolescents

NCT02563145 | Completed DMC

• 1 other identifier: EU Health-F2-2013-603016
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether real-time fMRI feedback is effective in the treatment of aggressive behavior problems in adolescents with high callous unemotional traits when compared to treatment as usual.

Conditions

Aggression; Conduct Disorder

Keywords

Real-time fMRI feedback

Outcome Measures

Primary Outcomes (1)

• Changes in aggressive behavior from baseline at 10 weeks and 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 weeks (questionnaire)

  Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment)

Secondary Outcomes (3)

• Changes in brain activation from baseline at 10 weeks after the beginning of the treatment phase as assessed by fMRI

  Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase)

• Changes in composition of neurotransmitter systems from baseline at 10 weeks after the beginning of the treatment phase as assessed by MRS

  Baseline and post treatment assessment (10 weeks after the beginning of the treatment phase)

• Changes in aggressive behavior from baseline at 10 weeks and at 6 months as reported by teachers through the aggressive behavior subscale of the TRF (Teachers Report Form)

  Baseline, post treatment assessment (10 weeks after beginning of the treatment phase) and follow up (6 months after end of the treatment)

Study Arms (3)

Real-time fMRI feedback

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 10 sessions of real-time fMRI feedback of insula- or amygdala activation (dependent on activation patterns during pre-testing), 1 session/week. Each session will last about 1 1/2 hours. After training completion (10 weeks after the beginning of the treatment phase), subjects will undergo post-treatment assessment and follow up (6 months after the end of the training phase).

Behavioral: Real-time fMRI feedback

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 TAU arm will receive several sessions of psychoeducation and counseling with their parents/caregivers or group training over 10 weeks. Within the sessions, investigators will focus on psychoeducational issues and provide general counseling for the families. After 10 weeks, subjects will undergo post-treatment assessment 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 subjects will only participate in pre-training assessment to allow for comparison.

Interventions

Real-time fMRI feedback BEHAVIORAL

feedback about activation patterns in brain regions related with instrumental aggression

Real-time fMRI feedback

Treatment as usual BEHAVIORAL

Psychoeducation, general counselling

Treatment as usual

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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 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)

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

Study Sites (1)

Department of Child and Adolescent Psychiatry and Psychotherapy, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany

Mannheim, 68159, Germany

Location

MeSH Terms

Conditions

Aggression; Conduct 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, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany

  PRINCIPAL INVESTIGATOR

• Tobias Banaschewski, MD, PhD

  Department of Child and Adolescent Psychiatry and Psychotherapy, CIMH Medical Faculty Mannheim/ Heidelberg University, Mannheim, Germany

  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: September 28, 2015
• First Posted: September 29, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

DE (1)