Co-creation of Tools for Children and Adolescents with Suicidal Thoughts And/or Behaviour
NCT06776328
Behavior, Behavioral Symptoms
Ghent, Belgium
View Trial DetailsNCT Number: NCT07554729
The goal of this observational study is to learn more about people who come to emergency departments in Spain after a suicide attempt and to find ways to prevent another attempt. The main questions are whether some personal, social, biological, and clinical factors are linked to a higher risk of trying again, and whether different follow-up strategies can help lower this risk over time.
Researchers will follow a total of about 3,600 people who attempted suicide: around 1,800 who were already recruited in a previous study and about 1,800 new participants who will be added in this project, in several hospitals across Spain.
Some participants may also be invited to give blood samples, answer online questionnaires, or use smartphone-based tools to understand better changes in mood and suicidal thoughts in daily life. A subset of participants may be invited to join separate clinical trials that test different follow-up programs to prevent another suicide attempt; these trials will be registered and described in their own study records.
Interested in participating?
Request Info12 year and older
All sexes
Observational
Hospital del Mar, Barcelona, Catalonia, Spain
BACKGROUND: Suicide is the leading preventable cause of death in the world. In Spain, the data show a growing trend in recent years, indicating the need to implement evidence-based prevention strategies. OBJECTIVES: The main objective of this study is to continue monitoring a previously established cohort of 1,800 suicide attempts and extend it to include 3,600 cases. The secondary objectives are: 1) to identify risk factors (1a: socioeconomic, psychological, and clinical, 1b: biological, and 1c: genetic) that can predict a repeat attempt, 2) to study suicidal behavior in the pandemic and post-pandemic times, 3) to identify phenotypes related to suicidal ideation and behavior using momentary ecological assessment and 4) to determine the efficacy of secondary prevention programs for suicidal behavior compared with treatment as usual (TaU). METHOD: Multi-center-coordinated cohort study with five nested clinical controlled trials. The participants will be recruited in nine centers distributed in the Spanish territory. The primary variable will be the time to repeat the attempt.
SUB-PROJECT 1: a) long-term follow-up study (5 years) of a cohort of suicide attempts (total n = 3600 cases), b) study of biological and c) genetic markers associated with a suicide attempt. SUB-PROJECT 2: will study suicidal ideation and behavior phenotypes using momentary ecological assessment and experience sampling. SUB-PROJECT 3: will evaluate the efficacy of different secondary prevention programs compared to TaU.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a brief, structured interview that uses simple questions about suicidal thoughts and behaviors to identify whether someone is at risk for suicide and how severe and urgent that risk is.
Time frame: 1 year
Nine-item self-report questionnaire that measures the severity of depressive symptoms over the past 2 weeks; total score ranges from 0 to 27, with higher scores indicating more severe depression.
Time frame: 1 year
Brief Description Seven-item self-report questionnaire that assesses symptoms of generalized anxiety during the past 2 weeks; total score ranges from 0 to 21, with higher scores indicating more severe anxiety.
Time frame: 1 year
Self-report questionnaire that screens for symptoms of borderline personality disorder; total score reflects the severity of borderline traits.
Time frame: 1 year
Checklist of major stressful life events; higher counts indicate greater exposure to recent stressors.
Time frame: baseline
Twenty-eight-item self-report measure that assesses history of childhood maltreatment across five domains (emotional, physical and sexual abuse, and emotional and physical neglect); higher subscale and total scores indicate more severe childhood trauma.
Time frame: 1 year
Five-item self-report scale that measures insomnia symptoms and their impact; total score indicates insomnia severity
Time frame: 1 year
Three-item self-report questionnaire that screens for hazardous alcohol consumption; higher scores indicate higher risk drinking
Time frame: 1 year
Two-item index derived from cigarettes per day and time to first cigarette; higher scores indicate greater nicotine dependence
Time frame: 1 year
Self-report screening tool for problematic use of non-alcohol drugs; total score reflects severity of drug-related problems
Time frame: 1 year
Eighteen-item self-report measure of problems in emotion regulation across several domains; higher scores reflect greater difficulties regulating emotions.
Time frame: 1 year
Self-report questionnaire with 30 items that evaluates different facets of impulsivity (attentional, motor and non-planning); higher total scores indicate greater impulsive traits.
Time frame: 1 year
Standardized questionnaire that assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression); higher index values reflect better perceived health.
Time frame: 1 year
Three-item self-report scale that screens for perceived loneliness and social isolation; higher scores indicate greater feelings of loneliness
Time frame: 1 year
Eight-item self-report questionnaire that assesses difficulties in understanding one's own and others' mental states; scores reflect problems in reflective functioning/mentalizing.
Time frame: 1 year
Self-report questionnaire that evaluates symptoms and severity of bulimic eating behaviors; higher scores indicate more severe bulimic pathology
Time frame: 1 year
Self-report questionnaire that measures the frequency and intensity of chronic feelings of emptiness; higher scores indicate more severe feelings of emptiness, often associated with borderline and suicidal presentations.
Time frame: 1 year
Brief questionnaire that assesses the size and frequency of supportive contacts with family and friends; lower scores indicate higher risk of social isolation
Time frame: Baseline
Study-specific questionnaire developed by the research team to collect sociodemographic and basic clinical information (for example age, sex, education, employment, living situation, psychiatric history, and treatment). Data will be used to describe the sample and as covariates in analyses
Contact information is provided by the study sponsor or research team.
Matilde Elices, Dr
CONTACT
Victor Perez-Sola, Dr
CONTACT
Parc de Salut Mar
Other
THE SURVIVE 2 PROJECT: AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN AND THE EFFICACY OF SECONDARY PREVENTION STRATEGIES
Acronym: SURVIVE 2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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