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

Official title

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

Overview

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.

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 no
• 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.

Primary outcome measures

• Change from Baseline in Suicidality (DSI-SS Score) [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Functional Assessment of Self-Mutilation (FASM) Frequency Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Self-Harm Screening Inventory (SHSI) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Circadian rhythm stability [Time frame: Through the end of the intervention period (approximately 12 weeks)]
• Researcher-Defined NSSI and Suicide Attempt Frequency [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Social Rhythm Stabilization [Time frame: Daily throughout the intervention period (8 weeks)]

Secondary outcome measures (12)

• Change from Baseline in Barratt Impulsiveness Scale (BIS-II) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Difficulties in Emotional Regulation Scale-Short Form (DERS-SF) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Distress Tolerance Scale (DTS) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Patient Health Questionnaire (PHQ-9) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Perceived Stress Scale (PSS) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Ruminative Response Scale-Short Form (RRS-SF) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in UCLA Loneliness Scale (ULS-6) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Perceived Invalidation of Emotion Scale (PIES) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Rosenberg Self-Esteem Scale (RSES) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Insomnia Severity Index (ISI) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]
• Change from Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score [Time frame: Baseline and Week 8, Baseline and Week 12]

Eligibility criteria

Inclusion criteria

• 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

• 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)
• 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

• 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
• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Ajou University Medical Center — Suwon

Identifiers

NCT: NCT07395752 · RS-2024-00409433

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗