Actively Recruiting

Age: 13Years - 18Years
All Genders
Healthy Volunteers
NCT05765864

Self-harm Behaviour Among the Most At-risk Adolescents

Led by University of Ljubljana, Faculty of Medicine · Updated on 2025-03-28

400

Participants Needed

2

Research Sites

131 weeks

Total Duration

On this page

Sponsors

U

University of Ljubljana, Faculty of Medicine

Lead Sponsor

U

University Medical Centre Ljubljana

Collaborating Sponsor

AI-Summary

What this Trial Is About

In the proposed study, three objectives will be pursued: 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. 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. Develop guidelines for more effective treatment of the most at-risk adolescents. For this purpose, a sample of approximately 200 young people who will be hospitalised for suicide risk (the most at risk in Slovenia) and an approximately equal number of healthy adolescents will be included. At inclusion, the presence of several factors will be assessed by reviewing demographic data, clinical diagnosis, self-assessment questionnaires and clinical psychological tests (CSSRS, B-NSSI-AT, ISAS, LPFS-BF2.0, BPFSC-11, TSCC, PAI, ECR-RS, DASA-YV, ASHRS), social assessment, and blood sampling for genetic analyses (DNA isolation, sequencing, nucleotide sequence recognition, quantification and evaluation of short tandem repeats, identification of methylation sites). Longitudinal tracking of autoaggressive events and heteroaggressive events during hospitalisation will be performed and recorded on an ongoing basis. The risk and protective factors of the adolescents most at risk will be compared with a control group of adolescents. The same factors will be reassessed in the most at-risk adolescents after 6 and 18 months of treatment as usual. The data will be collected in a data entry and storage system that will ensure the privacy of the data entered in accordance with the GDPR. This will allow the investigators to identify young people at particular risk of severe self-harm behaviour more reliably, to target them for more intensive and effective treatment, and thus to improve their safety, quality of life and prognosis in the short and long term.

CONDITIONS

Official Title

Self-harm Behaviour Among the Most At-risk Adolescents

Who Can Participate

Age: 13Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical group: Suicidality
  • Clinical group: Self-harming with no intention to die
  • Control group: Age 13-19 years
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Medical Faculty - University of Ljubljana

Ljubljana, Slovenia, 1000

Active, Not Recruiting

2

University Psychiatric Clinic Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

M

Maja Drobnič Radobuljac

CONTACT

M

Maja Drobnič Radobuljac

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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