Tracking Risk in Adolescents and Children for Early Identification of Common Mental Disorders

N/ANot Yet RecruitingNCT07744490

Shanghai Mental Health Center200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

High Risk Depression / Major Depressive Disorder Anxiety Disease Obsessive - Compulsive Disorder

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 7-17 years at enrollment. 2. 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. 3. 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. 4. Willing and able to participate in the scheduled assessments and follow-up visits. 5. Written informed consent provided by a parent or legal guardian and assent provided by the participant Exclusion Criteria: 1. A current or previous diagnosis of a depressive disorder, anxiety disorder, or obsessive-compulsive disorder. 2. A severe psychiatric condition requiring immediate clinical intervention, including acute suicide risk, a psychotic disorder, or a bipolar disorder. 3. A major neurological disorder, severe head injury, or serious or unstable medical condition that may interfere with study participation. 4. Intellectual or cognitive impairment that prevents the participant from understanding or completing the study assessments. 5. Inability or unwillingness of the participant or legal guardian to comply with the study procedures.

Outcomes

Primary Outcomes

Cumulative Incidence of Depressive Disorders, Anxiety Disorders, or Obsessive-Compulsive Disorder

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).

Time frame: From baseline through 24 months

Secondary Outcomes

Time to Onset of a Depressive Disorder, Anxiety Disorder, or Obsessive-Compulsive Disorder

Time from baseline to the first follow-up assessment at which a participant meets the diagnostic criteria for any target disorder, as determined using the K-SADS-PL.