Self-harm Behaviour Among the Most At-risk Adolescents (SH-MARA)
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ClinicalTrials.gov Identifier: NCT05765864 |
Recruitment Status :
Recruiting
First Posted : March 13, 2023
Last Update Posted : April 6, 2023
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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.
Condition or disease | Intervention/treatment |
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Self-harm Personality Disorder, Borderline Epigenetic Disorder Non-Suicidal Self Injury Change; Mental Difference, Individual | Diagnostic Test: Enrollment questionnaire, General questionnaire1, General questionnaire2, General questionnaire3 Diagnostic 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; ISAS Diagnostic Test: The Level of Personality Functioning Scale-Brief Form 2.0; LPFSBF 2.0 Diagnostic Test: Borderline Personality Features Scale, BPFSC-11 Other: Dynamic Appraisal of Situational Aggression-Youth Version (DASA-YV) Other: Adolescent Self-Harm Risk Scale; ASHRS Diagnostic Test: Lifetime Incidence of Traumatic Events questionnaire (LITE) Genetic: Genetic methods |
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Other |
Time Perspective: | Other |
Official Title: | Influences on and Prevention of Self-harm Behaviour Among the Most At-risk Adolescents |
Actual Study Start Date : | March 23, 2023 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | September 2025 |
Group/Cohort | Intervention/treatment |
---|---|
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.
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Diagnostic Test: 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. Diagnostic Test: Columbia Suicide Severity Rating Scale (CSSRS) 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. Diagnostic Test: The Brief Non-Suicidal Self-Injury Assessment Tool (B-NSSI-AT) 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. Diagnostic Test: Experiences in Close Relationships-Relationship Structures (ECR-RS) 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. Diagnostic Test: Trauma Symptom Checklist for Children (TSCC) 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 Diagnostic Test: Personality Assessment Inventory-Adolescent (PAI-A) 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 Diagnostic Test: Inventory Of Statements About Self-Injury; ISAS 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. Diagnostic Test: The Level of Personality Functioning Scale-Brief Form 2.0; LPFSBF 2.0 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. Diagnostic Test: Borderline Personality Features Scale, BPFSC-11 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. Other: Dynamic Appraisal of Situational Aggression-Youth Version (DASA-YV) 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. Other: Adolescent Self-Harm Risk Scale; ASHRS 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). Diagnostic Test: Lifetime Incidence of Traumatic Events questionnaire (LITE) 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 Genetic: Genetic methods DNA isolation, Sequencing, Libraries preparation, Analisys; Bioinformatics (Base Calling, Variant Calling, Quantification and evaluation of short tandem repetitions, Methylation sites detection). |
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 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. Diagnostic Test: Columbia Suicide Severity Rating Scale (CSSRS) 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. Diagnostic Test: The Brief Non-Suicidal Self-Injury Assessment Tool (B-NSSI-AT) 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. Diagnostic Test: Experiences in Close Relationships-Relationship Structures (ECR-RS) 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. Diagnostic Test: Trauma Symptom Checklist for Children (TSCC) 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 Diagnostic Test: Personality Assessment Inventory-Adolescent (PAI-A) 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 Diagnostic Test: Inventory Of Statements About Self-Injury; ISAS 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. Diagnostic Test: The Level of Personality Functioning Scale-Brief Form 2.0; LPFSBF 2.0 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. Diagnostic Test: Borderline Personality Features Scale, BPFSC-11 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. Other: Dynamic Appraisal of Situational Aggression-Youth Version (DASA-YV) 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. Other: Adolescent Self-Harm Risk Scale; ASHRS 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). Diagnostic Test: Lifetime Incidence of Traumatic Events questionnaire (LITE) 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 Genetic: Genetic methods DNA isolation, Sequencing, Libraries preparation, Analisys; Bioinformatics (Base Calling, Variant Calling, Quantification and evaluation of short tandem repetitions, Methylation sites detection). |
- Self-harm incident [ Time Frame: "through study completion, an average of 1 year" ]Registered incident of self-harm
- Prevented self-harm incident [ Time Frame: "up to 12 weeks" ]Registration of an intended self-harm prevented by hospital staff (nurses)
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05765864
Contact: Maja Drobnič Radobuljac | 015874840 ext +386 | maja.radobuljac@psih-klinika.si | |
Contact: Maja Drobnič Radobuljac | maja.radobuljac@psih-klinika.si |
Slovenia | |
Medical Faculty - University of Ljubljana | Active, not recruiting |
Ljubljana, Slovenia, 1000 | |
University Psychiatric Clinic Ljubljana | Recruiting |
Ljubljana, Slovenia, 1000 | |
Contact: Maja Drobnič Radobuljac, MD, PhD 015874840 ext +386 maja.radobuljac@mf.uni-lj.si | |
Contact: Sebastijan Mihelič 015874908 ext +386 sebastijan.mihelic@psih-klinika.si |
Principal Investigator: | Maja Drobnič Radobuljac | University Psychiatric Clinic Ljubljana |
Documents provided by Maja Drobnič Radobuljac, University of Ljubljana, Faculty of Medicine:
Responsible Party: | Maja Drobnič Radobuljac, Assist. prof. Maja Drobnič Radobuljac, MD, PhD, University of Ljubljana, Faculty of Medicine |
ClinicalTrials.gov Identifier: | NCT05765864 |
Other Study ID Numbers: |
Adolescent self-harm |
First Posted: | March 13, 2023 Key Record Dates |
Last Update Posted: | April 6, 2023 |
Last Verified: | April 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
adolescent deliberate self-harm risk and protective factors suicidal behavior non-suicidal self-injury |
risk assessment attachment genetics epigenetics |
Personality Disorders Self-Injurious Behavior Borderline Personality Disorder Mental Disorders Behavioral Symptoms |