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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Korea Health Industry Development Institute

  collaborator OTHER_GOV

• Sungshin Women's University

  collaborator OTHER

• Ajou University School of Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-30

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• South Korea

Study Locations