NCT05765864

Brief Summary

In the proposed study, three objectives will be pursued:

  1. 1.To develop a method to identify more effectively the acute and long-term risk of adolescents with the most threatening self-harm behaviours.
  2. 2.To identify the factors that influence the risk of self-harm behaviours and the success of treatment/treatment of these behaviours in the most at-risk adolescents (changes in these factors).
  3. 3.Develop guidelines for more effective treatment of the most at-risk adolescents.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

February 12, 2023

Last Update Submit

March 26, 2025

Conditions

Self-harmPersonality Disorder, BorderlineEpigenetic DisorderNon-Suicidal Self InjuryChange; MentalDifference, Individual

Keywords

adolescentdeliberate self-harmrisk and protective factorssuicidal behaviornon-suicidal self-injuryrisk assessmentattachmentgeneticsepigenetics

Outcome Measures

Primary Outcomes (2)

  • Self-harm incident

    Registered incident of self-harm

    "through study completion, an average of 1 year"

  • Prevented self-harm incident

    Registration of an intended self-harm prevented by hospital staff (nurses)

    "up to 12 weeks"

Study Arms (2)

Patients

The Enrollment Kit and Time1 Kit will be administered at enrollment, Time2 Kit will be administered before discharge and Time 3 kit after 6 and 18 months post hospitalization (see Detailed description and Study Protocol). The interventions will be Treatment as usual.

Diagnostic Test: Enrollment questionnaire, General questionnaire1, General questionnaire2, General questionnaire3Diagnostic Test: Columbia Suicide Severity Rating Scale (CSSRS)Diagnostic Test: The Brief Non-Suicidal Self-Injury Assessment Tool (B-NSSI-AT)Diagnostic Test: Experiences in Close Relationships-Relationship Structures (ECR-RS)Diagnostic Test: Trauma Symptom Checklist for Children (TSCC)Diagnostic Test: Personality Assessment Inventory-Adolescent (PAI-A)Diagnostic Test: Inventory Of Statements About Self-Injury; ISASDiagnostic Test: The Level of Personality Functioning Scale-Brief Form 2.0; LPFSBF 2.0Diagnostic Test: Borderline Personality Features Scale, BPFSC-11Other: Dynamic Appraisal of Situational Aggression-Youth Version (DASA-YV)Other: Adolescent Self-Harm Risk Scale; ASHRSDiagnostic Test: Lifetime Incidence of Traumatic Events questionnaire (LITE)Genetic: Genetic methods

Controls

The Enrollment Kit and the Time Kit1 will be administered (see Detailed description and Study Protocol).

Diagnostic Test: Enrollment questionnaire, General questionnaire1, General questionnaire2, General questionnaire3Diagnostic Test: Columbia Suicide Severity Rating Scale (CSSRS)Diagnostic Test: The Brief Non-Suicidal Self-Injury Assessment Tool (B-NSSI-AT)Diagnostic Test: Experiences in Close Relationships-Relationship Structures (ECR-RS)Diagnostic Test: Trauma Symptom Checklist for Children (TSCC)Diagnostic Test: Personality Assessment Inventory-Adolescent (PAI-A)Diagnostic Test: Inventory Of Statements About Self-Injury; ISASDiagnostic Test: The Level of Personality Functioning Scale-Brief Form 2.0; LPFSBF 2.0Diagnostic Test: Borderline Personality Features Scale, BPFSC-11Other: Dynamic Appraisal of Situational Aggression-Youth Version (DASA-YV)Other: Adolescent Self-Harm Risk Scale; ASHRSDiagnostic Test: Lifetime Incidence of Traumatic Events questionnaire (LITE)Genetic: Genetic methods

Interventions

Enrollment questionnaire, General questionnaire1, General questionnaire2, General questionnaire3DIAGNOSTIC_TEST

The questionnaires will cover general and demographic data, information on previous treatments, medication received, mental disorder at discharge (ICD), psychosocial situations (ICD), physical illnesses (ICD), COVID status (vaccinated, recovered, tested), use of psychoactive substances, history of self-harm, suicide attempts, school performance, experience with peers, sexual orientation and identity, residence, family composition, family history of mental disorders, self-harm and suicide attempts.

ControlsPatients
Columbia Suicide Severity Rating Scale (CSSRS)DIAGNOSTIC_TEST

The questionnaire is scientifically supported, has the most evidence of utility and efficacy, and is internationally accepted. It has been translated into more than 100 different languages, including Slovene. It is easy to use, suitable for all age groups and adapted for successful use outside the hospital setting, for example in schools, colleges, police, military and elsewhere. It contains 2 screening questions on suicidality and 4 more specific questions, 6 items in total. Posner K, Brown GK, Stanley B, et al. Am J Psychiatry 2011;168:1266-77.

ControlsPatients
The Brief Non-Suicidal Self-Injury Assessment Tool (B-NSSI-AT)DIAGNOSTIC_TEST

used for research purposes to assess the core characteristics of NSSI (form, frequency, function) as well as the secondary characteristics of NSSI (habituation, context of NSSI, perceived impact on life and treatment). Whitlock J, Exner-Cortens D, Purington A. Psychol Assess 2014;26:935-46.

ControlsPatients
Experiences in Close Relationships-Relationship Structures (ECR-RS)DIAGNOSTIC_TEST

Assesses the pattern of attachment to attachment figures (friend, romantic partner, mother, father) in adults and adolescents. The questionnaire has been officially translated into Slovene and used with several samples of Slovene adults and adolescents. Fraley RC, Waller NG, Brennan KA. J Pers Soc Psychol 2000;78:350-65.

ControlsPatients
Trauma Symptom Checklist for Children (TSCC)DIAGNOSTIC_TEST

The questionnaire helps to assess children's/adolescents' experiences of various traumatic experiences, such as physical or sexual violence, peer violence, loss, witnessing violent acts, natural disasters, etc. The questionnaire consists of 6 clinical scales (Anxiety, Depression, Anger, Post-traumatic Stress Symptom, Dissociativeness (two subscales), Sexual Concerns) and 2 validity scales. 6 clinical scales (Anxiety, Depressiveness, Anger, Post-traumatic Stress Symptom, Dissociativeness (two subscales), and 2 validity scales) are included. https://www.center-pds.si/Katalogtestov/Kliničnitesti/Vprašalnikotravmatiziranostiotrokinmladostnik. aspx

ControlsPatients
Personality Assessment Inventory-Adolescent (PAI-A)DIAGNOSTIC_TEST

An objective-type self-assessment questionnaire for assessing personality in adolescents. It has 264 items to be answered on a 4-point scale. 22 independent scales are obtained (Inconsistency, Rarity, Negative impression, Positive impression, Physical complaints, Anxiety, Anxiety-related disorders, Depressiveness, Mania, Paranoid, Schizophrenia, Borderline traits, Antisocial traits, Alcohol problems, Drug problems, Aggressiveness, Suicidal ideation, Stress, Lack of support, Refusal to deal, Dominance, Warmth). https://www.center-pds.si/Katalogtestov/Kliničnitesti/Vprašalnikzaocenoosebnosti-oblikazamladostnike-PAI-A.aspx

ControlsPatients
Inventory Of Statements About Self-Injury; ISASDIAGNOSTIC_TEST

A self-assessment questionnaire used for research purposes to assess the basic characteristics of NSSI (form, frequency, function, time to event). It also assesses the desire to stop. The questionnaire has been previously translated into Slovene and used in a population of adolescents with self-injurious behaviour. Glenn CR, Klonsky ED. One-year test-retest reliability of the Inventory of Statements about Self-Injury (ISAS). Assessment. 2011 Sep;18(3):375-8. doi: 10.1177/1073191111411669.

ControlsPatients
The Level of Personality Functioning Scale-Brief Form 2.0; LPFSBF 2.0DIAGNOSTIC_TEST

A short, user-friendly instrument that gives a quick impression of the expression of personality pathology. It consists of 12 items grouped into two higher-order domains: self-functioning and interpersonal functioning. Participants are asked to rate the 12 items on a four-point Likert scale ranging from 1 (completely false) to 4 (completely true). A total score (sum of all items), a self-functioning score (sum of items 1-6) and an interpersonal functioning score (sum of items 7-12) can be calculated. Satisfactory internal consistency and promising construct validity have been demonstrated. Sensitivity to change after three months of treatment was high. Weekers LC, Hutsebaut J, Kamphuis JH. The Level of Personality Functioning Scale-Brief Form 2.0: Update of a brief instrument for assessing level of personality functioning. Personal Ment Health 2019;13:3-14.

ControlsPatients
Borderline Personality Features Scale, BPFSC-11DIAGNOSTIC_TEST

The BPFS-C-11 includes BPD indicators such as affective instability, identity problems and negative attitudes. Responses to the items are on a 5-point Likert scale ranging from 'not at all true' to 'always true'. Studies have shown construct validity of interpretations of BPFS-C-11 scores through positive associations with other measures of BPD and positive associations with measures of BPD correlates, including emotional dysregulation. In a recent sample, the Cronbach's α over 4 years of follow-up was 0.86, 0.85, 0.86 and 0.90, respectively. The scale has been officially translated into Slovenian and will be used with the permission of the authors. It is intended for use by children and adolescents aged 9-11 years and consists of 11 items. Sharp, C., Steinberg, L., Temple, J., Newlin, E. An 11-Item Measure to Assess Borderline Traits in Adolescents: Refinement of the BPFSC Using IRT . Personality Disorders: Theory, Research, and Treatment 2014;5(1):70-78.

ControlsPatients
Dynamic Appraisal of Situational Aggression-Youth Version (DASA-YV)OTHER

It's a professional assessment tool which provides a daily assessment of the risk of heteroaggression. The evaluation is efficient and takes less than five minutes. The nurse in charge of each patient completes the DASA-YV once a day. Dutch SG, Patil N. Validating a Measurement Tool to Predict Aggressive Behavior in Hospitalized Youth. J Am Psychiatr Nurses Assoc 2019;25:396-404.

ControlsPatients
Adolescent Self-Harm Risk Scale; ASHRSOTHER

It's a professional assessment tool which provides a daily assessment of the risk of heteroaggression. This is the scale we developed for the present study. It will be used to assess and predict the short-term risk of self-harm behaviour during hospitalisation (assessment at admission) and the long-term risk after discharge (assessment at discharge).

ControlsPatients
Lifetime Incidence of Traumatic Events questionnaire (LITE)DIAGNOSTIC_TEST

Is a short checklist for screening and assessing the exposure to trauma in children and adolescents. It covers a broad range of potentially upsetting situations that can cause trauma to children and adolescents, such as a car accident, fire, death of a family member, exposure to threats, sexual assault, or witnessing violence. The questionnaire had been validated on a Slovene population of children and adolesscents. Greenwald R, Rubin A. Assessment of posttraumatic symptoms in children: development and preliminary validation of parent and child scales. Res Soc Work Pract. (1999) 9:61-75. doi: 10.1177/104973159900900105 Uršicˇ K, Bucik V, Klemencˇ icˇ S, Bratina N, Battelino T, Dovcˇ K and Drobnicˇ Radobuljac M (2021) Validation of the Lifetime Incidence of Traumatic Events (LITE-S/P) Questionnaires in Children and Adolescents in Slovenia. Front. Psychiatry 12:665315. doi: 10.3389/fpsyt.2021.665315

ControlsPatients
Genetic methodsGENETIC

DNA isolation, Sequencing, Libraries preparation, Analisys; Bioinformatics (Base Calling, Variant Calling, Quantification and evaluation of short tandem repetitions, Methylation sites detection).

ControlsPatients

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

CLINICAL GROUP: * patients hospitalized in the Intensive Child and Adolescent Psychiatry Unit or the Unit for Adolescent Psychiatry of the Centre for Mental Health University Psychiatric Clinic Ljubljana * aged between 13 and 19 years. * In the case of consent, parents will also be asked for consent for those under 15 years of age. CONTROL GROUP: * 8th grade students in primary school, * 1st year students in secondary school * 1st year students in college * aged 13-19 years * Attending a regular systematic review. These scheduled regular systematic examinations are accompanied by venous blood sampling.

You may qualify if:

  • Suicidality
  • Self-harming with no intention to die

You may not qualify if:

  • Confirmed acute psychotic disorder
  • Intellectual disability
  • Severe physical illness (e.g. cardiovascular or renal disease)
  • Disease of the central nervous system (e.g. encephalitis, brain injury or haemorrhage, epilepsy)
  • Acute poisoning (including with psychoactive substances)
  • CONTROL GROUP:
  • \- Age 13-19
  • Suicidality
  • Self-harming with no intention to die
  • Known mental disorder (e.g. depression, bipolar disorder, schizophrenia, intellectual disability)
  • Severe physical illness (e.g. cardiovascular or renal disease)
  • Disease of the central nervous system (e.g. encephalitis, brain injury or haemorrhage, epilepsy)
  • Acute poisoning (including with psychoactive substances)
  • Mental disorder, history of suicidality or self-injurious behaviour in a first-degree relative (a parent or a sibling).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Faculty - University of Ljubljana

Ljubljana, 1000, Slovenia

ACTIVE NOT RECRUITING

University Psychiatric Clinic Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

The genomic DNA is going to be isolated according to the established laboratory protocol using FlexGene DNA kit (Qiagen Germany) and 5 mL EDTA-blood sample. Isolated DNA will be stored at 4°C.

MeSH Terms

Conditions

Self-Injurious BehaviorBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonality DisordersMental Disorders

Study Officials

  • Maja Drobnič Radobuljac

    University Psychiatric Clinic Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Drobnič Radobuljac

CONTACT

015874840maja.radobuljac@psih-klinika.si

Maja Drobnič Radobuljac

CONTACT

maja.radobuljac@psih-klinika.si

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. prof. Maja Drobnič Radobuljac, MD, PhD

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 13, 2023

Study Start

March 23, 2023

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

SL(2)