NCT07395752

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

Development and Biological Efficacy Validation of Youth Suicide and Self-Harm Intervention Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is part of a national research initiative aimed at addressing youth suicide and self-harm, which have shown persistent increases and earlier onset in Korea. Despite the existence of many prevention programs, their effectiveness has been limited due to insufficient implementation strategies, lack of biological evidence, and the absence of structured, field-ready manuals or expert training systems. To overcome these limitations, this project seeks to develop, validate, and disseminate comprehensive suicide and self-harm intervention programs for adolescents and young adults. The study develops two tailored intervention programs-one for middle and high school students and one for young adults-based on mindfulness-informed and evidence-based techniques. The intervention differentiates between suicide and non-suicidal self-injury, addressing each with distinct therapeutic modules that reflect their unique psychological and neurobiological mechanisms. The programs will include emotion regulation skills, crisis response strategies, behavioral techniques, and structured manuals for both therapists and participants. Alongside the intervention, the study develops the first Korean clinical practice guidelines (CPGs) for suicide and self-harm in adolescents and young adults, based on extensive literature review, international guideline comparison, and expert consensus. The effectiveness of the intervention will be tested using a randomized or quasi-experimental design across multiple settings, including hospitals, community mental health centers, and schools. Clinical outcomes include suicidal ideation, self-harm behaviors, depressive symptoms, hopelessness, sleep disturbance, emotion regulation, and social rhythm stability. Biological outcomes will be evaluated using resting-state fMRI metrics (ALFF, ReHo, and functional connectivity) and other physiological indicators that reflect neural circuits implicated in suicide risk. The goal is to establish both clinical and biological evidence for the effectiveness of the program, achieve national certification for two intervention programs and one training curriculum, and ultimately develop an implementation model that can be scaled across community and clinical settings in Korea.

Conditions

• Suicidal Ideation
• Self-Injurious Behavior
• Suicide, Attempted

Interventions

Type	Name	Description
BEHAVIORAL	Self-Harm Intervention and Education for Long-term Development (SHIELD) Program	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
BEHAVIORAL	General Mental Health Education	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.

Timeline

• Start date: 2025-07-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: South Korea