[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623370":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":58,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Ajou University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nThe program includes tailored modules addressing:\n\nsuicidal ideation and self-injurious thoughts\u002Fbehaviors emotion regulation and distress tolerance (DBT-informed) mindfulness and attention regulation sleep and social rhythm stabilization crisis response and safety planning\n\nModules 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.",[13],"Behavioral: Self-Harm Intervention and Education for Long-term Development (SHIELD) Program",{"label":15,"type":16,"description":17,"interventionNames":18},"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.\n\nThe education program covers topics such as:\n\nunderstanding stress and mood\n\nhealthy coping strategies\n\nlifestyle factors related to mental well-being\n\nsleep hygiene\n\nhealthy routines and social relationships\n\nThis program does not include suicide- or self-harm-specific therapeutic components, nor modular DBT\u002Fmindfulness\u002Frhythm stabilization strategies used in the intervention group.\n\nParticipants complete the same baseline and follow-up psychological and biological assessments as the intervention group.",[19],"Behavioral: General Mental Health Education",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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:\n\n* 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.\n* 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.\n* 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.\n* Track 3: Young Adult Program (Ages 19-30): Addresses both self-harm and suicide-related issues through personalized modules inc",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yunmi Shin, MD","CONTACT","+82-31-219-5180","ymshin@ajou.ac.kr",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":26},"Sooyeon Aly Seo, Ph.D.","+82-2-920-7215",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":26,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ajou University Medical Center","RECRUITING","Suwon","Gyeonggi-do","16499","South Korea",{"type":49,"coordinates":50},"Point",[51,52],127.00889,37.29111,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":35,"phoneExt":26,"email":57},"Sangha Lee, Ph.D.","xrpsychology@gmail.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Yunmi Shin","Professor",[63,66],{"name":64,"class":65},"Korea Health Industry Development Institute","OTHER_GOV",{"name":67,"class":6},"Sungshin Women's University","100623370","youth-suicide-and-self-harm-intervention-clinical-and-biological-outcomes-study-100623370",false,"NCT07395752","Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study","Development and Biological Efficacy Validation of Youth Suicide and Self-Harm Intervention Program","SHIELD","Inclusion Criteria:\n\n1. General Criteria\n\n   * Aged between 15 and 30 years\n   * Obtained informed consent from a parent or legal guardian for participants under 19 years of age\n2. For the Self-Harm Group\n\n   * At least one incident of non-suicidal self-injury (NSSI) within the last 6 months\n   * Self-Harm Screening Inventory (SHSI) score of at least 1 (at least one \"Yes\" response)\n3. For the Suicide Attempt Group\n\n   * Suicide attempt within the last 6 months\n   * Depressive Symptom Inventory-Suicidality Subscale (DSI-SS) score of 3 or higher\n\nExclusion Criteria:\n\n1. Psychiatric and Developmental Conditions\n\n   * History of developmental disorders, including intellectual disability or autism spectrum disorder\n   * Diagnosis of schizophrenia or bipolar disorder\n   * Currently in an acute psychotic state\n2. Medical and Physical Conditions\n\n   * Presence of severe physical illness that interferes with daily life\n   * Presence of metallic substances in the body (e.g., cardiac pacemakers, artificial heart valves) that are incompatible with fMRI\n   * Diagnosis of claustrophobia\n   * Current Treatment and Intervention\n   * Currently receiving regular and active cognitive behavioral therapy (CBT)\n   * Initiation of pharmacological treatment within the last 2 months\n3. Communication and Consent\n\n   * Inability to communicate fluently in Korean\n   * Failure to obtain informed consent from a parent or legal guardian for participants under 19 years of age","ALL","15 Years","30 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","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.\n\nThe 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.\n\nThe main questions this study seeks to answer are:\n\n* Does the youth suicide and self-harm intervention program reduce suicidal ideation and self-injurious thoughts\u002Fbehaviors?\n* Does the program improve mood, sleep, hopelessness, and emotion regulation?\n* Are improvements in clinical outcomes accompanied by changes in biological markers of suicide risk?\n* Researchers will compare the intervention program to usual care provided in hospitals, schools, and community mental health settings.\n\nParticipants will:\n\n* Participate in the structured suicide\u002Fself-harm intervention program or receive usual care.\n* Complete standardized assessments of mood, sleep, emotion regulation and suicide\u002Fself-harm risk.\n* Undergo biological assessments, including resting-state fMRI and rhythm-related measures, at baseline and follow-up.\n* Be followed for up to 12 weeks.",[87,88,89],"Suicidal Ideation","Self-Injurious Behavior","Suicide, Attempted",[91,92,93,94,95,96,97],"Youth suicide","Suicidal ideation","Suicide attempt","fMRI","Social rhythm","Adolescents","Young adults","2026-05-04",{"date":100,"type":101},"2026-05-08","ACTUAL",{"date":103,"type":101},"2025-07-30",{"date":105,"type":81},"2026-12-31",{"name":5,"class":6},1]