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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-17
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Approximately 200 children and adolescents aged 7-17 years who are at elevated risk for depressive disorders, anxiety disorders, or obsessive-compulsive disorder will be enrolled. Elevated risk is defined by a relevant family history or clinically significant subthreshold emotional or repetitive behavioral symptoms. Participants will not meet the full diagnostic criteria for the target disorders at baseline and will be followed prospectively for two years.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Children and Adolescents at High Risk for Common Mental Disorders

Trial outcomes

Primary outcomes

1

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

1

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.

Time frame
From baseline through 24 months

Other outcomes

Sponsors and contacts

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Shanghai Mental Health Center

Lead sponsor

Fudan University

Collaborator

Southeast University, China

Collaborator

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