The STOP Study: Suicidality: Treatment Occurringin Paediatrics
Archieved Content Circa 2012
Suicidality: Treatment Occurringin Paediatrics (STOP). The STOP Study was a comprehensive evaluation of suicidality in children and adolescents. This was the study's website.
Content is from the site's 2012 - 2013 archived pages and other outside sources.
The STOP project aims to develop a comprehensive web-based methodology for the assessment and monitoring of suicidality in children and adolescents. The STOP consortium brings together renowned researchers from across Europe, each with a strong scientific and clinical background in this innovative child and adolescent psychiatry network. It has a mixed and balanced expertise with respect to pediatric psychopharmacology, suicidality, regulatory issues, and use of new technologies and infrastructure.
What are the aims of the STOP study?
Some children and adolescents have conditions that predispose them to suicidality. Medications used to treat medical or psychiatric conditions (some also associated with suicidal risk) may elevate suicidal thoughts or behaviors in a small proportion of patients. Clinicians treating children and adolescents, the patients themselves and their families need to know more about medication-related suicidality (MRS).
The STOP study aims to respond to different questions:
What are the best means to monitor MRS?
Is MRS different from suicidality related to the illness?
What biological, psycho-social or illness-related factors put some patients at high risk for MRS? What factors are likely to protect patients from MRS?
This assessment methodology will be used in three clinical samples to identify characteristic features of medication-related suicidality (MRS): children and adolescents receiving an atypical antipsychotic, children receiving fluoxetine for depression and children treated with montelukast for bronchial asthma. These medications were targeted because they have been related to suicidality.
Participate in the study
Why should I (or my kid) participate in the STOP study?
Your participation in the STOP study will help to increase our knowledge about suicidality and MRS. Specifically, you will help us to set up better assessments so that suicidality can be identified and treated quickly. Your participation will lead to a better understanding of the risk factors and mechanisms underlying suicidal ideation and behaviour.
By participating in the STOP study you will have the opportunity to meet clinicians and researchers from our academic expert teams. Their goal is to optimize treatments and follow up monitoring for children and adolescents with mental or physical conditions, to make those treatments more secure. As a participant, you will be informed about the STOP study progress and will have access to updated research and therapeutic issues related to suicidality and MRS.
How to participate in the study
The STOP project will recruit children and adolescents followed up for depression, asthma and for conduct disorder. Before these studies can be started, we will also recruit children treated in the STOP centres (for different conditions) to help us finalizing a questionnaire that will then be used to develop our web-based assessment.
To participate in a given study of the STOP project, yourself or your parents can contact us to obtain detailed information about the different studies.
Background: STOP Project
General Information: Suicidality
Suicidality refers to suicidal ideation and suicide-related behaviors including completed suicide. Suicidal ideation comprises thoughts related to suicide and suicide plans. Suicide related behaviors include:
- completed suicide: self-inflicted death with intention to die,
- suicidal attempts: self-inflicted potentially harmful behavior without fatal issue but with intention to die,
- self harm: deliberate self-inflicted potentially harmful act regardless of motive.
The term of deliberate self harm refers to self-inflicted injuries regardless of the intent to die. In the UK, the term has been changed to “self-harm” to avoid the connotation of intentionality (however, in the US literature, the term self-harm qualifies intentional injuries without intent to die e.g. “self-mutilation”). A suicide threat is the communication of a suicidal intent whereas a suicide plan is a concrete suicide project.
Suicide is one of the tenth leading cause for deaths worldwide contributing 1.5% of all deaths. Approximately 1 million people die due to suicide each year.
Risk of suicidal ideation increases rapidly during adolescence and young adulthood and stabilizes in early midlife. The greatest risk for suicidal attempts is in adolescence and early adulthood. The prevalence rates in adolescents are reported cross-nationally to be 19.8-24.0% for suicidal ideation, and 3.1% - 8.8% for suicidal attempts.
Suicide is the second cause of death among young people, after accidents. The rates of suicide vary according to age; in childhood and early adolescence suicide is rare but suicide rates increase in adolescents and young adulthood. The latest mean worldwide annual rates of suicide per 100 000 were 0.5 for females and 0.9 for males among 5-14-year-olds, and 12.0 for females and 14.2 for males among 15-24-year-olds, respectively. Males often outnumber females in worldwide youth completed suicide statistics, although suicide attempts are more frequent in females.
Due to the growing risk for suicide with increasing age, adolescents are the main target of suicide prevention as less than half of young people who have committed suicide had received psychiatric care.
Are suicidal ideation, attempts and completed suicide related?
Suicidal ideation and behaviours can occur both independently and together. The majority of individuals who report suicidal ideation will not try to commit suicide. Research across 17 countries has suggested that those who have suicidal ideations have the conditional probability of 29% of ever making a suicide attempt. However, attempt increases to 56% for those who do have suicidal ideation and have formulated a plan, but without this plan only 15.4% are likely to attempt suicide. The majority of these transitions will occur within the first year of the onset of suicidal ideation.
In patients having attempted suicide, 24,5 % will commit another suicidal attempt in the next seven years. The risk of suicide in the year following a suicidal attempt is 30 to 200 times higher in comparison with the general population and increases with the number of suicidal attempts, particularly in women.
Is self-harm related to suicidality?
The progression from suicidal ideation to self-harm and then to suicide is by no means absolute. However of those patients who present to hospital with self-harm, around 7% will have completed suicide over a 9 year period of follow-up The suicide rate appears to be higher amongst those patients who abscond from medical care or who took precautions against discovery .
What are the main risk factors of suicidality?
Primary risk factors are associated with high individual risk and are likely targets for therapeutic interventions. Main primary risk factors are : familial and personal antecedents of suicidal behavior, presence of a psychiatric disorder (mainly depressive disorders and disruptive behaviors), substance use such as repeated acute alcohol intake , the communication of suicidal intent, high impulsivity, high hopelessness (sub-clinical depressive symptoms), presence of a chronic physical illness. Secondary risk factors are identified in the community and are only partially modifiable; they comprise early loss of a parent, social isolation, unemployment or financial problems, severe adverse life events, being actor or victim of violence. Tertiary risk factors are statistically associated with suicidal risk but carry a low individual predictive value: age (adolescence and old age), male gender, vulnerability periods (summer, premenstrual period in women).
Assessment of suicidality in general
Patients presenting with suicidal ideation or following a suicide attempt should be assessed at three levels: presence of risk factors, immediacy of suicidal risk and dangerousness of the suicidal means. The immediacy of suicidal risk involves the existence of a suicidal scenario and is rated high if the suicidal plan is precise and concrete, moderate if the plan is imprecise and low in the absence of a scenario. The absence of alternative for the patient also contributes to the immediacy of risk. Assessment of suicidal means refers to lethality and accessibility of the considered suicide method. Suicidality is generally assessed through clinical interview, eventually completed by questionnaires.
Screening procedures have been developed to identify at-risk children and adolescents in order to offer prevention services. These include self-report measures such as the Columbia Suicide Screen the Suicide Risk Screen and the Suicidal Ideation Questionnaire – Junior (SIQ-Jr) . Universal screening in school settings for example carry the risk of identifying false positives and the issue of follow-up of subjects with positive screens; screening in at-risk groups (children/adolescents in emergency departments, in primary care) is an important issue that also calls for outcome assessments.
What is medication-related suicidality?
The term ‘Medication-Related Suicidality’ (MRS) is a reported adverse event and is defined as any suicide-related symptoms that are reported during the period of treatment with the drug. Symptoms include suicidal ideation, suicidal plans and suicidal behaviours and sometimes also extend to non-suicidal self-harm.
What are the mechanisms of medication-related suicidality?
Assessment of suicidality in relation to drugs is difficult in particular in children and adolescents because of a number of reasons: 1) Assessment procedures of suicidality developed in adults may not be appropriate for younger people (e.g. differences in self-assessment, ability to communicate emotions, abstract thinking) 2) Suicidality related to pharmacological treatment may be different from suicidality related to disease. 3) Notification and recording of suicidality is variable across clinical trials
How can medication-related suicidality be assessed?
Assessment of suicidality in relation to drugs is difficult in particular in children and adolescents because of a number of reasons: 1) Assessment procedures of suicidality developed in adults may not be appropriate for younger people (e.g. differences in self-assessment, ability to communicate emotions, abstract thinking) 2) Suicidality related to pharmacological treatment may be different from suicidality related to disease. 3) Notification and recording of suicidality is variable across clinical trials.
The mechanisms involved in increased suicidal ideation and behaviour during treatment are unknown. It has been proposed that medication may induce behavioural activation, including anxiety, irritability, agitation, and insomnia, which would facilitate suicidality, presumably mainly in the first weeks of treatment. Analyses of community clinical practice databases show conflicting results: some have indeed indicated that the rate of suicidal behaviour is highest in the first month of treatment, and especially during the first nine days but in other analyses the rate was actually the highest in the month prior to starting antidepressant medication with a gradual decline during treatment. Time patterns of suicide attempts in clinical populations show highest rates of suicide attempts in the month before treatment and next highest in the month after starting treatment and decrease afterwards; these time patterns have been shown in adult outpatients with both medications and psychotherapy. Most suicidal events in the antidepressant trials conducted in children and adolescents occurred in the context of persistent depression and insufficient improvement, without evidence of medication-induced behavioral activation as a precursor.
What are the expected improvements in assessing MRS with the STOP project?
It is the aim of the STOP project to create a multidimensional assessment and monitoring tool to detect and follow-up suicidal ideas and behaviors that could be implemented in clinical practice and in clinical trials. This assessment will be based on two classifications: the classification of suicide related thoughts and behavior (17) and the Columbia Classification Algorithm of suicidal assessment (C-CASA) (14). The output of the STOP assessment is a computer generated classification of suicidality. This comprehensive assessment of suicidality and related individual and environmental variables (moderators and mediators of suicidality) will contribute to a better understanding of the specific characteristics of medication-related suicidality. Once standardized, the STOP classification could be used for pharmacovigilance and in epidemiological, observational and registration trials.
There is insufficient data available about safety of using many medications in children and adolescents who may have an illness that itself predispose them to suicidality. There is also insufficient data available about the time-course of medication related suicidality and what happens to it over the long-term. Further, there is insufficient data available about the long-term safety, in particular about medication related suicidality, especially since there is evidence to suggest that paediatric populations may represent a vulnerable group compared to adults.
The STOP project arises from the collaboration of a group of experts in paediatric psychopharmacology within the framework of the European Child and Adolescent Paediatric Network (ECAPN). ECAPN is supported by the European College of Neuropsychopharmacology (ECNP) (www.ecnp.eu) and its network initiative (EcnpNI).
The STOP project aims to develop a comprehensive web-based methodology for the assessment and monitoring of suicidality in children and adolescents. Four domains are of importance for this purpose: assessment and monitoring of suicidality, assessment of putative risk and protective factors but also mediators (intermediate outcomes contributing to treatment effects), assessment of psychiatric and physical symptoms and medication characteristics.
This assessment methodology will be used in three clinical samples to identify characteristic features of medication-related suicidality (MRS): children and adolescent receiving an atypical antipsychotic, children receiving fluoxetine for depression and children treated with montelukast for bronchial asthma. These medications were targeted because they have been related to suicidality.
Summary of the STOP project
The project consists of 12 Workpackages (WPs).
WP1 covers the management of the overall project.
WPs 2 to 4 are each focusing on specific aspects of the bio-psycho-social mediators of suicidality. WP2 consists in a meta-analysis looking for medication-related suicidality signals in an international database. WP3 establishes the biological sampling methodology for investigation of mediators of suicidality and WP4 focuses on the psychosocial mediators of suicidality.
WP5 focuses on the assessment of suicidality. WP6 converts the assessment of suicidality and the bio-psycho-social mediators of suicidality (including specific psychopathology and medical illness assessment, and medication characteristics) into an online data-capture module, which will be and translated to Dutch, French, Spanish, Italian, German and Bengali Syletti.
WPs 7-9 focus on clinical trials of antipsychotics, fluoxetine and montelukast:
WP7 consists in a 12 month longitudinal naturalistic prospective pharmacovigilance study in children and adolescents treated with risperidone for different indications
WP8 consists in a 12 month longitudinal naturalistic prospective pharmacovigilance study in children and adolescents treated with fluoxetine
WP9 consists in a 12 month longitudinal naturalistic prospective pharmacovigilance study in children and adolescents treated with montelukast for bronchial asthma.
WP10-12 deal with special topics that are relevant to the overall project and the clinical studies/WPs:
WP10 contains an outline of our approach to training of all professionals and researchers that will be involved in the clinical studies.
WP11 describes our approach to the ethical issues that are relevant to the whole process of preparing and performing the clinical studies and analysing, reporting and implementing and dissemination of the results.
WP12 will address the important issue of the dissemination of the results of our project.
Scientific Advisory Board
The Scientific, Clinical and Ethical Advisory Board will ensure a high standard of research and monitor the progress of the project by taking part in the annual General Assembly Meetings. The Board will also fulfil the tasks of the Data Safety Monitoring Board. Whenever appropriate, the consortium will consult the Advisory Board for recommendations to improve the performance of the consortium. Members of the Board are:
- Alessandro Serretti, MD, PhD, Institute of Psychiatry, University of Bologna, Italy
- Eric Taylor, Prof, Institute of Psychiatry, King's College London, UK
- Benedetto Vitiello, MD, National Institute of Mental Health, United States of America
The STOP consortium
STOP represents a unique mix of people with different skills all dedicated towards the better assessment of suicidality in children and adolescents and the study of medication related suicidality. This team is drawn from different EU member states, cultures and backgrounds but all working together towards a common goal.
The coordinator of the STOP project is Dr. Paramala Santosh from the Department of Child and Adolescent Psychiatry PO85| Institute of Psychiatry| 16 De'Crespigny Park | London | SE5 8AF
Head of the Centre for Interventional Paediatric Psychopharmacology (CIPP) Child and Adolescent Mental Health Services Michael Rutter Centre | Maudsley Hospital | De'Crespigny Park | London | SE5 8AZ