Suicidal IdeationSHIELDNCT07395752
Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study
A study testing Self-Harm Intervention and Education for Long-term Development (SHIELD) Program and General Mental Health Education in people with Suicidal Ideation and Self-Injurious Behavior, run by Ajou University School of Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Suicidal Ideation, Self-Injurious Behavior, Suicide, Attempted
- What is being tested?
- Self-Harm Intervention and Education for Long-term Development (SHIELD) Program and General Mental Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 9Show fewer
- For the Suicide Attempt Group
- Suicide attempt within the last 6 months
- Depressive Symptom Inventory-Suicidality Subscale (DSI-SS) score of 3 or higher
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sooyeon Aly Seo, Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Medical Center
Suwon, Gyeonggi-do, 16499
Sangha Lee, Ph.D., +82-31-219-5180, xrpsychology@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Self-Harm Intervention and Education for Long-term Development (SHIELD) Program, General Mental Health Education
- Keywords
- Youth suicide, Suicidal ideation, Suicide attempt, fMRI, Social rhythm, Adolescents, Young adults
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Harm Intervention and Education for Long-term Development (SHIELD) ProgramBehavioural
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
General Mental Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Youth Suicide and Self-Harm Intervention Program | Experimental | 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. Receives: Behavioral: Self-Harm Intervention and Education for Long-term Development (SHIELD) Program |
| General Mental Health Education Program | Active comparator | 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. Receives: Behavioral: General Mental Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Daily throughout the intervention period (8 weeks)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 8, Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start30 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either the intervention program or a usual-care comparison group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Sungshin Women's University
- Responsible party
- Principal investigator, Yunmi Shin, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395752
- Sponsor's protocol ID
- RS-2024-00409433
- Acronym
- SHIELD
- Status last verified
- May 2026
- First submitted
- 1 Feb 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Biological Efficacy Validation of Youth Suicide and Self-Harm Intervention Program
- ClinicalTrials.gov ID
- NCT07395752
- Acronym / sponsor ID
- SHIELD / RS-2024-00409433
- Keywords
- Youth suicide, Suicidal ideation, Suicide attempt, fMRI, Social rhythm, Adolescents, Young adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Sungshin Women's University
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to either the intervention program or a usual-care comparison group.
| Arm | Type | Receives |
|---|---|---|
| Youth Suicide and Self-Harm Intervention Program | Experimental | Behavioral: Self-Harm Intervention and Education for Long-term Development (SHIELD) ProgramA 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. |
| General Mental Health Education Program | Active comparator | Behavioral: General Mental Health EducationParticipants 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. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- General Criteria
- For the Self-Harm Group
- For the Suicide Attempt Group
Key exclusion criteria (14 listed)
- Psychiatric and Developmental Conditions
- Medical and Physical Conditions
- Communication and Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Harm Intervention and Education for Long-term Development (SHIELD) ProgramA 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 | Behavioural | Youth Suicide and Self-Harm Intervention Program |
| General Mental Health EducationParticipants 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. | Behavioural | General Mental Health Education Program |
Primary outcome
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).
13 secondary outcomes
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
Change from Baseline in Sleep Health Index (SHI) Score
Time frame: Baseline and Week 8, Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. 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.
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Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sooyeon Aly Seo, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Harm Intervention and Education for Long-term Development (SHIELD) Program and General Mental Health Education in people with Suicidal Ideation and Self-Injurious Behavior, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunmi Shin, MD (+82-31-219-5180, ymshin@ajou.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Suicidality (DSI-SS Score) (time frame: Baseline and Week 8, Baseline and Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.