Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study

Recruiting now · Not applicable

Conditions studied: Suicidal Ideation, Self-Injurious Behavior, Suicide, Attempted

In brief

The goal of this clinical trial is to develop and evaluate youth-focused intervention programs for suicide and self-harm that are tailored to the psychological, developmental, and cultural characteristics of Korean adolescents and young adults. The study examines whether two structured, mindfulness-based intervention programs-one for middle and high school students and one for young adults-reduce suicidal ideation, self-harm behaviors, depressive symptoms, and emotion-regulation difficulties. The study also aims to determine whether these clinical improvements are associated with biological changes, including alterations in resting-state functional brain activity (e.g., ALFF, ReHo, and functional connectivity) and social rhythm patterns. The main questions this study seeks to answer are: * Does the youth suicide and self-harm intervention program reduce suicidal ideation and self-injurious thoughts/behaviors? * Does the program improve mood, sleep, hopelessness, and emotion regulation? * Are improvements in clinical outcomes accompanied by changes in biological markers of suicide risk? * Researchers will compare the intervention program to usual care provided in hospitals, schools, and community mental health settings. Participants will: * Participate in the structured suicide/self-harm intervention program or receive usual care. * Complete standardized assessments of mood, sleep, emotion regulation and suicide/self-harm risk. * Undergo biological assessments, including resting-state fMRI and rhythm-related measures, at baseline and follow-up. * Be followed for up to 12 weeks.

Key facts

Study ID

NCT07395752

Run by

Ajou University School of Medicine

People needed

100

Starts

2025-07-30

Expected to finish

2026-12-31

Last updated by the study team

2026-05-08

Who can join

Age: 15 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General Criteria
• Aged between 15 and 30 years
• Obtained informed consent from a parent or legal guardian for participants under 19 years of age
• For the Self-Harm Group
• At least one incident of non-suicidal self-injury (NSSI) within the last 6 months
• Self-Harm Screening Inventory (SHSI) score of at least 1 (at least one "Yes" response)
• For the Suicide Attempt Group
• Suicide attempt within the last 6 months
• Depressive Symptom Inventory-Suicidality Subscale (DSI-SS) score of 3 or higher

You may not qualify if…

• Psychiatric and Developmental Conditions
• History of developmental disorders, including intellectual disability or autism spectrum disorder
• Diagnosis of schizophrenia or bipolar disorder
• Currently in an acute psychotic state
• Medical and Physical Conditions
• Presence of severe physical illness that interferes with daily life
• Presence of metallic substances in the body (e.g., cardiac pacemakers, artificial heart valves) that are incompatible with fMRI
• Diagnosis of claustrophobia
• Current Treatment and Intervention
• Currently receiving regular and active cognitive behavioral therapy (CBT)
• Initiation of pharmacological treatment within the last 2 months
• Communication and Consent
• Inability to communicate fluently in Korean
• Failure to obtain informed consent from a parent or legal guardian for participants under 19 years of age

Where it is running

• Ajou University Medical Center — Suwon, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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