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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-30
SponsorAjou University School of Medicine

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ajou University School of Medicine

Lead sponsor

Korea Health Industry Development Institute

Collaborator

Sungshin Women's University

Collaborator