Actively Recruiting

Phase Not Applicable
Age: 15Years - 30Years
All Genders
NCT07395752

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

Led by Ajou University School of Medicine · Updated on 2026-05-08

100

Participants Needed

1

Research Sites

74 weeks

Total Duration

On this page

Sponsors

A

Ajou University School of Medicine

Lead Sponsor

K

Korea Health Industry Development Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 15Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 15 and 30 years
  • Informed consent obtained from a parent or legal guardian for participants under 19 years
  • For Self-Harm Group: At least one incident of non-suicidal self-injury within the last 6 months
  • For Self-Harm Group: Self-Harm Screening Inventory (SHSI) score of at least 1
  • For Suicide Attempt Group: Suicide attempt within the last 6 months
  • For Suicide Attempt Group: Depressive Symptom Inventory-Suicidality Subscale (DSI-SS) score of 3 or higher
Not Eligible

You will not qualify if you...

  • History of developmental disorders including intellectual disability or autism spectrum disorder
  • Diagnosis of schizophrenia or bipolar disorder
  • Currently in an acute psychotic state
  • Severe physical illness interfering with daily life
  • Presence of metallic substances incompatible with fMRI (e.g., pacemakers, artificial heart valves)
  • Diagnosis of claustrophobia
  • Currently receiving regular and active cognitive behavioral therapy (CBT)
  • Started pharmacological treatment within the last 2 months
  • Inability to communicate fluently in Korean
  • Failure to obtain informed consent from parent or guardian for participants under 19 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea, 16499

Actively Recruiting

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Research Team

Y

Yunmi Shin, MD

CONTACT

S

Sooyeon Aly Seo, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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