Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed With Attention Deficit Hyperactivity Disorder at Alexandria University Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Impulsive aggression severity
研究概览
简要总结
This trial aims to Study the efficacy of DBT skills for impulsive aggression and executive dysfunctions in drug naïve children who are presented with impulsive aggression and ADHD and attending Child and adolescent clinic at Alexandria university hospitals using weekly group therapy for 8 month and testing pre and posttreatment biomarkers of aggression.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients from 6 to 13-year-old.
- •Patients diagnosed with ADHD and presented with impulsive aggression.
- •Commitment to therapy from the child and the parent.
- •Written consent of all the children parents.
- •Male gender.
- •Drug naïve or stopped medications for at least one month.
排除标准
- •Patients younger than 6 years of age as it's the starting age for DBT-C.
- •Patients who dropped from DBT skills group (missing more than 3 consecutive sessions) whether the child or his parent.
- •Patients diagnosed with drug abuse.
- •Patients with severe sensory impairment or intellectual disability.
- •Drug induced aggression as levetiracetam, topiramate and benzodiazepines.
- •Patients diagnosed with Autism spectrum disorder or psychotic disorders.
研究组 & 干预措施
The intervention group (group A) DBT skills
Will attend Dialectical Behavioral Therapy skills group for both the children and their parents, DBT is an evidence based comprehensive cognitive behavioral treatment for complex mental disorders and have been adapted for intractable behavioral disorders involving emotion dysregulation, skills will be provided in group therapy as fixed weekly sessions over 9-month duration for all the children and the parents in group A including:
- Emotion regulation skills module over 8 weeks.
- Mindfulness skills module over 3 weeks
- Interpersonal effectiveness skills module over 7 weeks.
- Distress tolerance skills module over 8 weeks.
- Walking the middle path skills module over 3 weeks.
干预措施: Dialectical behavioral therapy skills for the intervention experimental group A (Behavioral)
the control group (group B)
Will receive psychoeducation and medications targeting ADHD symptoms (stimulants or atomoxetine according to FDA approved dose per age and weight) according to the international guidelines for management of ADHD according to symptom severity, given that assessment before and after intervention will be done by different medical personnel than those providing the intervention for the two groups.
干预措施: psychoeducation or Atomoxetine or stimulants according to ADHD severity (Drug)
结局指标
主要结局
Impulsive aggression severity
时间窗: Change from Baseline at 12 month
Using Modified overt aggression scale ,This scale rates the patient's aggressive behavior regarding four types of aggression (verbal, against objects, against self, against others) to give a total MOAS score about the patient's aggressive behavior. Each type of aggression had a rating of 0 when aggression was absent and four levels of severity. Weighted scores are then added together to yield the total score.
Biomarkers of aggression 1
时间窗: Change from Baseline 12 month
quantitative CRP
Biomarkers of aggression 2
时间窗: Change from Baseline 12 month
interleukin 6
Biomarkers of aggression 3
时间窗: Change from Baseline 12 month
Serum cortisol level (at 9 am and 9 pm) using The enzyme-linked immunosorbent assay (ELISA) technique
次要结局
- Executive dysfunctions severity(Change from Baseline 12 month)
- ADHD symptom severity(Change from Baseline 12 month)
研究者
Aya Maged
Doctor
Alexandria University