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

A Longitudinal Study for Risk Identification of Common Mental Disorders in High-Risk Children and Adolescents

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07744490

Acronym

TRACE

Enrollment

200

Registered

2026-08-04

Start date

2026-07-25

Completion date

2030-12-31

Last updated

2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

children and adolescence, pediatric, high risk, mental disease

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Cumulative Incidence of Depressive Disorders, Anxiety Disorders, or Obsessive-Compulsive Disorder	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).

Secondary

Measure	Time frame	Description
Time to Onset of a Depressive Disorder, Anxiety Disorder, or Obsessive-Compulsive Disorder	From baseline through 24 months	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.

Countries

China

Contacts

CONTACTZhen Wang, PhD, MD

wangzhen@smhc.org.cn+8634773516

PRINCIPAL_INVESTIGATORZhen Wang

Shanghai Mental Health Center

Outcome results