A Longitudinal Study for Risk Identification of Common Mental Disorders in High-Risk Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Depressive Disorders, Anxiety Disorders, or Obsessive-Compulsive Disorder
研究概览
简要总结
This prospective observational cohort study will enroll approximately 200 children and adolescents aged 7-17 years who are at elevated risk for common mental disorders, including depressive disorders, anxiety disorders, and obsessive-compulsive disorder, based on family history or subthreshold emotional or behavioral symptoms. Participants will be followed for two years. Clinical assessments, questionnaires, EEG, biological samples, and MRI will be collected at scheduled intervals. The study aims to identify factors associated with the onset and progression of these disorders and support early risk identification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 7-17 years at enrollment.
- •Meeting at least one of the following conditions: Having at least one first-degree relative with a depressive disorder, anxiety disorder, or obsessive-compulsive disorder; or exhibiting clinically relevant but subthreshold depressive, anxiety, obsessive-compulsive, or repetitive behavioral symptoms.
- •Not meeting the full diagnostic criteria for a depressive disorder, anxiety disorder, or obsessive-compulsive disorder at baseline, as assessed using the K-SADS-PL.
- •Willing and able to participate in the scheduled assessments and follow-up visits.
- •Written informed consent provided by a parent or legal guardian and assent provided by the participant
排除标准
- •A current or previous diagnosis of a depressive disorder, anxiety disorder, or obsessive-compulsive disorder.
- •A severe psychiatric condition requiring immediate clinical intervention, including acute suicide risk, a psychotic disorder, or a bipolar disorder.
- •A major neurological disorder, severe head injury, or serious or unstable medical condition that may interfere with study participation.
- •Intellectual or cognitive impairment that prevents the participant from understanding or completing the study assessments.
- •Inability or unwillingness of the participant or legal guardian to comply with the study procedures.
结局指标
主要结局
Cumulative Incidence of Depressive Disorders, Anxiety Disorders, or Obsessive-Compulsive Disorder
时间窗: From baseline through 24 months
The proportion of participants who newly meet the diagnostic criteria for at least one depressive disorder, anxiety disorder, or obsessive-compulsive disorder during follow-up, as determined using the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
次要结局
- Time to Onset of a Depressive Disorder, Anxiety Disorder, or Obsessive-Compulsive Disorder(From baseline through 24 months)
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center