Emotional Dysregulation in Children With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Attention Deficit Hyperactivity Disorder-Rating Scale total score
研究概览
简要总结
Studies have shown that children with Attention Deficit Hyperactivity Disorder (ADHD) and emotional dysregulation are characterized by high severity of ADHD, comorbid behavior disorders and increased risk of chronic difficulties.
New studies have shown promising results by focusing on improving emotional regulation. We lack knowledge about differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress.
Children 6 to 12 years admitted to specialist and diagnosed with ADHD will be recruited. ADHD children with and without emotional dysregulation defined as fullfilling the criteria for the diagnosis Disruptive Mood Dysregulation Disorder (DMDD) with regard to differences in symptom patterns, stability of symptoms over time, comorbid disorders, neurocognitive functions, knowledge and regulation of emotions, psychosocial risk factors and reactions to stress..
详细描述
Children referred to outpatient psychiatric service will be informed about the study and asked to participate. The clinical assessments in the study will be those that are recommended as good clinical practice, so results will be included in the diagnostic work for the patient.
The data security will follow the Norwegian rules and be monitored by REC and the Data Inspectorate of the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to outpatient psychiatric service.
- •IQ within normal range.
- •Child and parents: Good enough understanding of Norwegian language to give valid answers in interviews and tests.
排除标准
- •IQ below normal range.
- •Child and parents: Not good enough understanding of Norwegian language to give valid answers in interviews and tests.
- •Unresolved crisis in the family.
结局指标
主要结局
Attention Deficit Hyperactivity Disorder-Rating Scale total score
时间窗: 12 months
Symptom score. Measure difference from baseline. Lower score means improvement.
Affect recognition total score
时间窗: Baseline
Test from NEPSY II. Comparison With norms. Difference from norm reported.
Hair cortisol Level
时间窗: Baseline
Cortisol level over time
Disruptive Mood Dysregulation Disorder total symptom questionnaire score
时间窗: 12 months
Symptom score. Symptom score. Measure difference from baseline. Lower score means improvement.
Number of other comorbid disorders in psychiatric interview
时间窗: Baseline
DSM-5 diagnoses: Types and number of diagnoses. More diagnoses means more complex disorder.
次要结局
未报告次要终点
研究者
Pål Zeiner
Project manager
Oslo University Hospital