Development and Biological Efficacy Validation of Youth Suicide and Self-Harm Intervention Program
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ajou University School of Medicine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Suicidality (DSI-SS Score)
Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors will be blinded to participant assignment to minimize assessment bias.
Eligibility Criteria
- Ages
- 15 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Self-Harm Intervention and Education for Long-term Development (SHIELD) Program (Behavioral)
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.
Intervention: General Mental Health Education (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline in Suicidality (DSI-SS Score)
Time Frame: Baseline and Week 8, Baseline and Week 12
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.
Change from Baseline in Functional Assessment of Self-Mutilation (FASM) Frequency Score
Time Frame: Baseline and Week 8, Baseline and Week 12
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.
Change from Baseline in Self-Harm Screening Inventory (SHSI) Total Score
Time Frame: Baseline and Week 8, Baseline and Week 12
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.
Change from Baseline in Circadian rhythm stability
Time Frame: Through the end of the intervention period (approximately 12 weeks)
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.
Researcher-Defined NSSI and Suicide Attempt Frequency
Time Frame: Baseline and Week 8, Baseline and Week 12
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.
Change from Baseline in Social Rhythm Stabilization
Time Frame: Daily throughout the intervention period (8 weeks)
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).
Secondary Outcomes
- Change from Baseline in Barratt Impulsiveness Scale (BIS-II) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Difficulties in Emotional Regulation Scale-Short Form (DERS-SF) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Distress Tolerance Scale (DTS) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Patient Health Questionnaire (PHQ-9) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Perceived Stress Scale (PSS) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Ruminative Response Scale-Short Form (RRS-SF) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in UCLA Loneliness Scale (ULS-6) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Perceived Invalidation of Emotion Scale (PIES) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Rosenberg Self-Esteem Scale (RSES) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Insomnia Severity Index (ISI) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score(Baseline and Week 8, Baseline and Week 12)
- Change from Baseline in Sleep Health Index (SHI) Score(Baseline and Week 8, Baseline and Week 12)
Investigators
Yunmi Shin
Professor
Ajou University School of Medicine