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

NCT07395752 | Recruiting

• 1 other identifier: RS-2024-00409433
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Self-Injurious Behavior; Suicide, Attempted

Keywords

Youth suicide; Suicidal ideation; Suicide attempt; fMRI; Social rhythm; Adolescents; Young adults

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (13)

• 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

Study Arms (2)

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.

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.

Behavioral: General Mental Health Education

Interventions

Self-Harm Intervention and Education for Long-term Development (SHIELD) Program BEHAVIORAL

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

Youth Suicide and Self-Harm Intervention Program

General Mental Health Education BEHAVIORAL

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.

General Mental Health Education Program

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• Korea Health Industry Development Institute: collaborator
• Sungshin Women's University: collaborator

Study Sites (1)

Ajou University Medical Center

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Self-Injurious Behavior; Suicide, Attempted

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Yunmi Shin, MD

CONTACT

+82-31-219-5180; ymshin@ajou.ac.kr

Sooyeon Aly Seo, Ph.D.

CONTACT

+82-2-920-7215

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participant assignment to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be assigned to either the intervention program or a usual-care comparison group.

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: July 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)