Actively Recruiting
Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study
Led by Ajou University School of Medicine · Updated on 2026-05-08
100
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
A
Ajou University School of Medicine
Lead Sponsor
K
Korea Health Industry Development Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 15 and 30 years
- Informed consent obtained from a parent or legal guardian for participants under 19 years
- For Self-Harm Group: At least one incident of non-suicidal self-injury within the last 6 months
- For Self-Harm Group: Self-Harm Screening Inventory (SHSI) score of at least 1
- For Suicide Attempt Group: Suicide attempt within the last 6 months
- For Suicide Attempt Group: Depressive Symptom Inventory-Suicidality Subscale (DSI-SS) score of 3 or higher
You will not qualify if you...
- History of developmental disorders including intellectual disability or autism spectrum disorder
- Diagnosis of schizophrenia or bipolar disorder
- Currently in an acute psychotic state
- Severe physical illness interfering with daily life
- Presence of metallic substances incompatible with fMRI (e.g., pacemakers, artificial heart valves)
- Diagnosis of claustrophobia
- Currently receiving regular and active cognitive behavioral therapy (CBT)
- Started pharmacological treatment within the last 2 months
- Inability to communicate fluently in Korean
- Failure to obtain informed consent from parent or guardian for participants under 19 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
Research Team
Y
Yunmi Shin, MD
CONTACT
S
Sooyeon Aly Seo, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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