NCT05765864 Self-harm Behaviour Among the Most At-risk Adolescents
| NCT ID | NCT05765864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ljubljana, Faculty of Medicine |
| Condition | Self-harm |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-03-23 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
CLINICAL GROUP: Inclusion Criteria: * Suicidality * Self-harming with no intention to die Exclusion Criteria: * 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: Inclusion Criteria: \- Age 13-19 Exclusion criteria: * 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 & Investigator
Maja Drobnič Radobuljac
PRINCIPAL INVESTIGATOR
University Psychiatric Clinic Ljubljana
Frequently Asked Questions
Who can join the NCT05765864 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Self-harm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05765864 currently recruiting?
Yes, NCT05765864 is actively recruiting participants. Contact the research team at maja.radobuljac@psih-klinika.si for enrollment information.
Where is the NCT05765864 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia, Ljubljana, Slovenia.
Who is sponsoring the NCT05765864 clinical trial?
NCT05765864 is sponsored by University of Ljubljana, Faculty of Medicine. The principal investigator is Maja Drobnič Radobuljac at University Psychiatric Clinic Ljubljana. The trial plans to enroll 400 participants.