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

RecruitingNAAges 15 Years - 30 YearsAllAjou University School of Medicine
NCT07395752 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-inju

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. General Criteria * Aged between 15 and 30 years * Obtained informed consent from a parent or legal guardian for participants under 19 years of age 2. 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) 3. 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 Criteria: 1. 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 2. 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 3. 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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What it tests

  • Self-Harm Intervention and Education for Long-term Development (SHIELD) Program
  • General Mental Health Education
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Where

1 site
Ajou University Medical Center
Suwon, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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