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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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:
- Can participants gain increasing control over their arousal level through biofeedback training of electrodermal activity?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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)
排除标准
- •(both groups):
- •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
研究组 & 干预措施
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).
干预措施: Individualized Arousal-Biofeedback (Behavioral)
Typically developing (TD) control group
Healthy, typically developing children will only undergo baseline assessment (observational) for comparison
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).
干预措施: Treatment as usual (Behavioral)
结局指标
主要结局
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)
时间窗: Baseline, evaluation after 10 weeks of treatment, post treatment assessment (20 weeks after the beginning of the training), follow up at 6 months
Parents or caregivers report on type and intensity of aggressive behavior over the last week (questionnaire)
次要结局
- 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)