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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior
• Intervention / Treatment: Behavioral: Self-Harm Intervention and Education for Long-term Development (SHIELD) Program; Behavioral: General Mental Health Education

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunmi Shin, MD; Phone Number: +82-31-219-5180; Email: ymshin@ajou.ac.kr
• Study Contact Backup: Name: Sooyeon Aly Seo, Ph.D.; Phone Number: +82-2-920-7215

Study Locations

• South Korea
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Recruiting
      • Ajou University Medical Center
      • Contact: Sangha Lee, Ph.D.; Phone Number: +82-31-219-5180; Email: xrpsychology@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. General Criteria

   • Aged between 15 and 30 years
   • Obtained informed consent from a parent or legal guardian for participants under 19 years of age

2. 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)

3. 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:

1. 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

2. 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

3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Youth Suicide and Self-Harm Intervention Program; A structured modular intervention program integrating mindfulness-based techniques, Dialectical Behavior Therapy (DBT) skills, and social rhythm stabilization strategies for adolescents and young adults at elevated risk for suicide and self-harm. The program includes tailored modules addressing: suicidal ideation and self-injurious thoughts/behaviors emotion regulation and distress tolerance (DBT-informed) mindfulness and attention regulation sleep and social rhythm stabilization crisis response and safety planning Modules are delivered by trained clinicians using a standardized manual, with components adjusted to the developmental needs of adolescents versus young adults. Participants complete psychological and biological assessments (e.g., resting-state fMRI) at baseline and follow-up.	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
Active Comparator: General Mental Health Education Program; Participants in the active comparator group will receive a general mental health education program of equal duration and session frequency as the intervention group. The education program covers topics such as: understanding stress and mood healthy coping strategies lifestyle factors related to mental well-being sleep hygiene healthy routines and social relationships This program does not include suicide- or self-harm-specific therapeutic components, nor modular DBT/mindfulness/rhythm stabilization strategies used in the intervention group. Participants complete the same baseline and follow-up psychological and biological assessments as the intervention group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Suicidality (DSI-SS Score)	The DSI-SS is a 4-item self-report questionnaire designed to assess the frequency and intensity of suicidal ideation and impulses. Scores range from 0 to 12, with higher scores indicating greater severity of suicidality; a score of 3 or higher is considered the clinical cut-off for high suicide risk.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Functional Assessment of Self-Mutilation (FASM) Frequency Score	The FASM assesses the methods and frequency of non-suicidal self-injury (NSSI), as well as the functions maintaining the behavior. It distinguishes between Internal Functions (e.g., emotion regulation) and Social Functions (e.g., influencing others). The instrument yields data on the total frequency of self-mutilative behaviors and separate scores for these functional domains.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Self-Harm Screening Inventory (SHSI) Total Score	The SHSI is a 10-item self-report measure used to screen for non-suicidal self-injury (NSSI) behaviors over the past year. It assesses 10 specific methods of self-harm (e.g., cutting, hitting, overdosing) performed without the intent to die. Each item is scored as 0 (No) or 1 (Yes). Total scores range from 0 to 10; a score of 1 or higher (indicating any experience of self-harm) is the cut-off for recommending a visit to a psychiatrist.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Circadian rhythm stability	Circadian rhythm stability refers to the consistency of 24-hour rest-activity patterns across days, as assessed using wrist-worn actigraphy. Inter-daily Stability (IS) quantifies the degree of similarity between daily activity profiles across consecutive days, with values ranging from 0 to 1. Higher IS values indicate greater stability and synchronization of the circadian rest-activity rhythm.	Through the end of the intervention period (approximately 12 weeks)
Researcher-Defined NSSI and Suicide Attempt Frequency	These researcher-defined items assess the frequency of Non-Suicidal Self-Injury (NSSI) and suicide attempts. NSSI frequency is measured across four timeframes (lifetime, past year, past month, past week) using a 7-point ordinal scale ranging from 'Once' to '50 times or more'. Suicide attempts are assessed by total lifetime frequency (4-point scale) and the recency of the most recent attempt. Higher scores on frequency items indicate a greater number of incidents.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Social Rhythm Stabilization	The Social Rhythm Stabilization Score assesses the regularity of daily routines (e.g., sleep, activities) through the completion of a daily social rhythm log. Variability is derived using 'Max-Min' for durations and 'Circular Time Distance' for clock times. Lower values indicate greater stability. Scores are categorized as: Very Regular (≤ 30), Regular (31-60), Mildly Variable (61-90), Variable (91-120), Irregular (121-180), and Very Irregular (> 180).	Daily throughout the intervention period (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Barratt Impulsiveness Scale (BIS-II) Total Score	The BIS-II is a 23-item questionnaire designed to assess the personality construct of impulsiveness. Total scores range from 23 to 92, where higher scores indicate higher levels of impulsiveness.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Difficulties in Emotional Regulation Scale-Short Form (DERS-SF) Total Score	The DERS-SF is an 18-item self-report measure used to assess difficulties in emotion regulation. Scores range from 18 to 90, where higher scores indicate greater difficulty in emotion regulation.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Distress Tolerance Scale (DTS) Total Score	The DTS is a 15-item self-report measure of emotional distress tolerance. Scores range from 15 to 75, with higher scores indicating higher levels of distress tolerance (i.e., better capacity to withstand distress).	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score	The GAD-7 is a 7-item instrument used to assess the severity of generalized anxiety. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Severity categories are defined as Mild (5-9), Moderate (10-14), and Severe (15-21). A total score of 10 or greater is the clinical cut-off for identifying probable generalized anxiety disorder.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Patient Health Questionnaire (PHQ-9) Total Score	The PHQ-9 is a 9-item module used to screen for and measure the severity of depression. Scores range from 0 to 27, where higher scores indicate greater severity of depressive symptoms.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Perceived Stress Scale (PSS) Total Score	The PSS is a 10-item instrument used to measure the perception of stress. Scores range from 0 to 40, with higher scores indicating higher levels of perceived stress. Stress levels are categorized as Low (0-13), Moderate (14-26), and High (27-40).	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Ruminative Response Scale-Short Form (RRS-SF) Total Score	The RRS-SF is a 10-item measure that assesses rumination in response to depressed mood. Scores range from 10 to 40, where higher scores indicate higher levels of rumination.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in UCLA Loneliness Scale (ULS-6) Total Score	The ULS-6 is a 6-item scale designed to measure subjective feelings of loneliness and social isolation. Scores range from 0 to 18, where higher scores indicate higher levels of loneliness.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Perceived Invalidation of Emotion Scale (PIES) Total Score	The PIES is a 10-item instrument that measures the extent to which an individual perceives their emotions as being invalidated by others. Total scores range from 10 to 50, where higher scores indicate higher levels of perceived emotional invalidation.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Rosenberg Self-Esteem Scale (RSES) Total Score	The RSES is a 10-item scale that measures global self-worth. Scores range from 10 to 40, with higher scores indicating higher self-esteem.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Insomnia Severity Index (ISI) Total Score	The ISI is a 7-item instrument measuring the nature, severity, and impact of insomnia. Scores range from 0 to 28, with higher scores indicating more severe insomnia symptoms.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score	The PDSS is an 8-item self-report measure of daytime sleepiness in school-aged children. Scores range from 0 to 32, with higher scores indicating greater daytime sleepiness.	Baseline and Week 8, Baseline and Week 12
Change from Baseline in Sleep Health Index (SHI) Score	The Sleep Health Index (SHI) is a 16-item instrument that assesses sleep health across three sub-domains: Sleep Quality, Sleep Duration, and Sleep Disorders. Raw scores are converted into a standardized index ranging from 0 to 100. A higher score indicates better sleep health.	Baseline and Week 8, Baseline and Week 12

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: Korea Health Industry Development Institute; Sungshin Women's University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; fMRI; Young adults; Suicidal ideation; Suicide attempt; Youth suicide; Social rhythm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Behavior; Suicidal Ideation; Self-Injurious Behavior; Suicide, Attempted; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: RS-2024-00409433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared outside the primary research group. This study involves sensitive data collected from minors and young adults pertaining to suicidal ideation, suicide attempts, and non-suicidal self-injury. Given the highly sensitive and potentially identifiable nature of this information, sharing de-identified IPD with external researchers is not planned, in order to protect participant confidentiality and ensure compliance with Korean data protection regulations (Personal Information Protection Act) and institutional ethics requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No