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

Browse trials for

• Suicidal Ideation 509
• Self-Injurious Behavior 247
• Suicide, Attempted 262

Keywords

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

Study arms

• 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

• 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

Interventions

• BehavioralSelf-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

• BehavioralGeneral 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.

Primary outcomes

1. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

2. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

3. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

4. 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.

   Time frame: Through the end of the intervention period (approximately 12 weeks)

5. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

6. 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).

   Time frame: Daily throughout the intervention period (8 weeks)

Secondary outcomes

1. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

2. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

3. 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).

   Time frame: Baseline and Week 8, Baseline and Week 12

4. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

5. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

6. 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).

   Time frame: Baseline and Week 8, Baseline and Week 12

7. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

8. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

9. 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.

   Time frame: Baseline and Week 8, Baseline and Week 12

10. 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.

    Time frame: Baseline and Week 8, Baseline and Week 12

11. 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.

    Time frame: Baseline and Week 8, Baseline and Week 12

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.

    Time frame: Baseline and Week 8, Baseline and Week 12

13. 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.

    Time frame: Baseline and Week 8, Baseline and Week 12

Individual participant data

Plan to share: 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.