Influences on and Prevention of Self-harm Behaviour Among the Most At-risk Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Self-harm incident
研究概览
简要总结
In the proposed study, three objectives will be pursued:
- To develop a method to identify more effectively the acute and long-term risk of adolescents with the most threatening self-harm behaviours.
- 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).
- 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.
详细描述
DESCRIPTION OF THE RESEARCH PROJECT "Influences on and prevention of self-harm behaviour among the most at-risk adolescents".
- Scientific background Detailed in the attached Study Protocol
- Detailed description of the work programme 2.1. Content and work programme The study will include 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. At enrolment, the investigators will assess the presence of several factors by reviewing demographic data, clinical diagnosis, self-assessment questionnaires, social assessment, clinical psychological tests, rating scales and blood sampling for genetic analyses. They will longitudinally track autoaggressive events and heteroaggressive events in the patients during hospitalisation and keep a running record of them. The risk and protective factors of the most at-risk adolescents will be compared to a control group of healthy adolescents. The same factors in the most at-risk adolescents will be reassessed after 6 and 18 months of treatment. A detailed description of the study design is given in Figure 2 and Table 2 of Study Protocol.
2.2. Subjects: Subjects with inclusion and exclusion criteria are described in Table 2 (Study Protocol, WP2).
2.3. Methods: 2.3.1. Questionnaires and psychodiagnostic tools:
- Enrollment questionnaire, General questionnaire1, General questionnaire2, General questionnaire3: 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.
- Columbia Suicide Severity Rating Scale (CSSRS).
- The Brief Non-Suicidal Self-Injury Assessment Tool (B-NSSI-AT).
- Personality Assessment Inventory-Adolescent (PAI-A).
- Trauma Symptom Checklist for Children (TSCC).
- Experiences in Close Relationships-Relationship Structures (ECR-RS).
- Dynamic Appraisal of Situational Aggression-Youth Version (DASA-YV).
- Adolescent Self-Harm Risk Scale (ASHRS): this is the scale we developed for the present study.
- The Level of Personality Functioning Scale-Brief Form 2.0 (LPFSBF 2.0).
- Lifetime Incidence of Traumatic Events questionnaire (LITE).
- Borderline Personality Features Scale (BPFSC-11).
- Inventory Of Statements About Self-Injury (ISAS).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suicidality
- •Self-harming with no intention to die
排除标准
- •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).
结局指标
主要结局
Self-harm incident
时间窗: "through study completion, an average of 1 year"
Registered incident of self-harm
Prevented self-harm incident
时间窗: "up to 12 weeks"
Registration of an intended self-harm prevented by hospital staff (nurses)
次要结局
未报告次要终点
研究者
Maja Drobnič Radobuljac
Assist. prof. Maja Drobnič Radobuljac, MD, PhD
University of Ljubljana, Faculty of Medicine