Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training

Browse trials for

• Self-Injurious Behavior 303

Keywords

• Non-Suicidal Self-Injury (NSSI)
• Adolescent
• Adolescent Self-Injury Intervention Skills Training
• Psychological Intervention
• Treatment Response
• Neurobiological Mechanisms
• Functional Brain Connectivity
• Machine Learning

Self-Injurious Behavior

303 studies on the registry are indexed under Self-Injurious Behavior; 105 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 254 interventional studies indexed under Self-Injurious Behavior.

Lead sponsor

Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.

Study arms

• Experimental
  Adolescent Self-Injury Intervention Skills Training (ASIST)

  Participants assigned to this arm will receive Adolescent Self-Injury Intervention Skills Training (ASIST), a structured psychological intervention developed for adolescents who engage in non-suicidal self-injury. The program consists of four sessions delivered over four weeks and incorporates cognitive behavioral therapy, emotion regulation, stress coping skills, and interpersonal skills training. The sessions focus on understanding self-injury and developing safety plans, identifying and modifying negative automatic thoughts, improving emotional awareness and regulation, and developing adaptive stress coping strategies. Participants who continue to demonstrate clinically significant difficulties at the four-week follow-up assessment may receive two additional advanced sessions targeting cognitive biases and difficulties identifying and expressing emotions.

  Behavioral: Adolescent Self-Injury Intervention Skills Training (ASIST)

• Active comparator
  Treatment as Usual (TAU)

  Participants assigned to this arm will receive treatment as usual (TAU) for non-suicidal self-injury over four weeks. Treatment will consist of routine clinical interventions typically provided to adolescents presenting with self-injurious behaviors in child and adolescent psychiatric settings, including psychoeducation on self-injury prevention, safety planning, behavioral chain analysis, counseling, and supportive psychotherapy. Participants will undergo the same baseline, post-treatment, and four-week follow-up assessments as those in the ASIST group.

  Behavioral: Treatment as Usual (TAU)

Interventions

• BehavioralAdolescent Self-Injury Intervention Skills Training (ASIST)

  ASIST is a structured psychological intervention developed for adolescents who engage in non-suicidal self-injury. The program consists of four sessions delivered over four weeks, focusing on: (1) understanding self-injury, behavioral chain analysis, and safety planning; (2) identifying and modifying automatic thoughts, core beliefs, and rumination; (3) improving emotional awareness, expression, and regulation; and (4) developing stress management, coping, and interpersonal communication skills. The intervention incorporates cognitive behavioral and emotion regulation strategies. Participants with persistent clinically significant difficulties at the four-week follow-up may receive two additional sessions addressing cognitive and interpretation biases and difficulties identifying and expressing emotions.

• BehavioralTreatment as Usual (TAU)

  Participants assigned to the TAU group will receive routine clinical care for non-suicidal self-injurious behavior over a 4-week period. Depending on their individual clinical needs, treatment may include psychoeducation, safety planning, behavioral chain analysis, counseling, and supportive psychotherapy, consistent with usual care practices in child and adolescent psychiatry.

Primary outcomes

1. Change in Self-Harming Behaviors as Assessed by the Self-Harm Inventory (SHI)

   Self-harming behaviors will be assessed using the Korean version of the Self-Harm Inventory (SHI), a 20-item self-report questionnaire evaluating the frequency of self-harming and self-destructive behaviors. Participants rate each item based on their experiences over the past 4 weeks or their current experiences, using a 4-point Likert scale ranging from 1 (almost never) to 4 (always). Total scores range from 20 to 80, with higher scores indicating more frequent or severe self-harming behaviors. Changes in total SHI scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).

   Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)

Secondary outcomes

1. Change in Frequency of Non-Suicidal Self-Injury as Assessed by the Korean Inventory of Statements About Self-Injury (K-ISAS)

   The functions of non-suicidal self-injury (NSSI) will be assessed using the K-ISAS, a self-report questionnaire evaluating NSSI behaviors and their underlying functions. The assessment of NSSI functions consists of 39 items measuring 13 functions of NSSI, categorized into intrapersonal and interpersonal functions. Each item is rated on a 3-point Likert scale ranging from 0 (not relevant) to 2 (very relevant), yielding a total score ranging from 0 to 78. Higher scores indicate greater endorsement of NSSI functions. Changes in total scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).

   Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)

2. Change in Severity of Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

   Suicidal ideation severity will be assessed using the C-SSRS, assessing suicidal ideation and behavior. Suicidal ideation severity is evaluated using five yes/no items and scored on a scale from 0 (no suicidal ideation) to 5 (active suicidal ideation with a specific plan and intent). Higher scores indicate greater severity of suicidal ideation. A suicidal ideation severity score of 4 or higher will be used as the cutoff for elevated suicide risk in this study. Changes in suicidal ideation severity scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).

   Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)

3. Change in Emotion Regulation Difficulties as Assessed by the Difficulties in Emotion Regulation Scale-16 (DERS-16)

   DERS-16 is a 16-item self-report questionnaire designed to assess difficulties in emotion regulation across five domains: nonacceptance of emotional responses, difficulties engaging in goal-directed behavior, impulse control difficulties, limited access to emotion regulation strategies, and lack of emotional clarity. Each item is rated on a 5-point Likert scale ranging from 0 (almost never) to 5 (almost always), yielding a total score ranging from 16 to 80. Higher scores indicate greater difficulties in emotion regulation. Changes in total DERS-16 scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).

   Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)

4. Change in Impulsivity as Assessed by the Barratt Impulsiveness Scale-Brief (BIS-Brief)

   The BIS-Brief is an 8-item self-report questionnaire designed to assess impulsivity as a unidimensional construct. Each item is rated on a 4-point Likert scale ranging from 0 (never) to 3 (almost always), yielding a total score ranging from 0 to 24. Higher scores indicate greater impulsivity. Changes in total BIS-Brief scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).

   Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)

5. Change in Depressive Symptom Severity as Assessed by the Children's Depression Rating Scale-Revised (CDRS-R)

   The CDRS-R is a 17-item clinician-rated scale to measure the severity of depression of children and adolescents. The scale evaluates emotional, cognitive, behavioral, and somatic symptoms associated with depression. Depression symptoms are rated on a 5-point scale from 1 to 5 for sleep, appetite, and tempo of speech items and a 7-point scale from 1 to 7 for remaining 14 items. Total scores range from 17 (normal) to 113 (severe depression), with higher scores indicating greater severity of depressive symptoms. Changes in total CDRS-R scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).

   Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)

6. Change in Anxiety Symptoms as Assessed by the Screen for Child Anxiety Related Emotional Disorders (SCARED)

   The SCARED is a 41-item questionnaire designed to assess anxiety symptoms in children and adolescents across five domains: panic/somatic symptoms, generalized anxiety, separation anxiety, social anxiety, and school avoidance. Each item is rated on a 3-point Likert scale ranging from 0 (not true or hardly ever true) to 2 (very true or often true), yielding a total score ranging from 0 to 82. Higher scores indicate greater severity of anxiety symptoms. A total score of 25 or higher suggests the possible presence of an anxiety disorder, while a score of 30 or higher indicates increased likelihood of an anxiety disorder. Changes in total SCARED scores will be evaluated from baseline (V1) to post-intervention (V5) and from baseline (V1) to the 4-week follow-up (V6).

   Time frame: Baseline (V1, Week 1), Post-intervention (V5, Weeks 4-5), and 4-week Follow-up (V6, Weeks 8-9)