Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study
Development and Biological Efficacy Validation of Youth Suicide and Self-Harm Intervention Program
Ajou University School of Medicine
100 participants
Jul 30, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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
Exclusion Criteria14
- 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
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Interventions
A structured, module-based psychological intervention program consisting of 8 weekly sessions. The program is tailored into three customized tracks based on the participant's age and clinical needs: * Common Core Module (Cross-cutting): Social Rhythm Therapy (SRT) is applied to all participants starting from Session 2 to stabilize daily routines (sleep, meals, activities) and reduce emotional impulsivity. * Track 1: Youth Self-Harm Program (Ages 14-18): Focuses on functional understanding of non-suicidal self-injury, mindfulness-based emotion regulation, interpersonal skills, and behavioral therapy. * Track 2: Youth Suicide Program (Ages 14-18): Includes an intensive behavioral therapy session (Session 3) for crisis analysis, followed by mindfulness, interpersonal skills, and cognitive therapy modules to enhance resilience and prevent suicide attempts. * Track 3: Young Adult Program (Ages 19-30): Addresses both self-harm and suicide-related issues through personalized modules inc
Participants watch 8 educational videos over an 8-week period. The education is ideally conducted at the research site. Similar to the intervention group, participants are also required to use a wearable device during the study period.
Locations(1)
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NCT07395752