Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:57 AM
Study NCT ID:
NCT07422493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suicidal Behavior in Adolescents and Executive Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of executive functioning impairment in adolescents presenting suicidal behaviors, ranging from suicidal ideation to suicide attempts', 'timeFrame': 'Baseline', 'description': 'Scores obtained on the composite indices of the FEE battery will be used to determine the presence of executive function impairment. Adolescents scoring at or above the 90th percentile for their age and sex on at least one of the four domains assessed by the FEE battery will be considered as presenting executive function impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent', 'Executive functions', 'suicide'], 'conditions': ['Suicidal Behavior', 'Adolescent']}, 'descriptionModule': {'briefSummary': 'Suicide is a major public health concern, particularly among young people. In France, around 400 adolescents die by suicide every year, and suicide attempts are most frequent during adolescence. This stage of life is marked by profound emotional, social, and biological changes, which can increase vulnerability to stress and psychological distress.\n\nCurrent research shows that suicidal behaviors do not result from a single cause. Instead, they emerge from a complex interaction between individual vulnerabilities and stressful life events. Among these vulnerabilities, cognitive functioning-and more specifically executive functions-has attracted growing scientific interest.\n\nExecutive functions refer to a set of high-level mental abilities that allow individuals to regulate their thoughts, emotions, and actions. They include skills such as controlling impulses, adapting to new situations, planning ahead, and holding information in mind. These abilities are essential for everyday life, school learning, social interactions, and emotional regulation. Importantly, the brain networks supporting executive functions continue to develop throughout adolescence, making them particularly sensitive to psychological and environmental challenges.\n\nIn adults, several studies have shown that people with suicidal ideation or a history of suicide attempts often present difficulties in executive functioning. Such difficulties may contribute to poorer emotional regulation, increased rumination, reduced impulse control, and impaired decision-making during periods of crisis. However, in adolescents, research in this area remains limited, often involving small samples or focusing on only one or two cognitive abilities.\n\nThe main aim of this study is therefore to better understand the relationship between executive functions and suicidal behaviors in adolescents, using a comprehensive assessment tool specifically designed and validated for children and teenagers. This tool allows for a global evaluation of key executive components, including inhibition, working memory, cognitive flexibility, and planning.\n\nA secondary objective of the study is to compare executive functioning between adolescents who experience suicidal thoughts and those who have attempted suicide. Some findings in adults suggest that these two groups may show different cognitive profiles, but this distinction has rarely been explored in younger populations.\n\nIn addition, cognitive difficulties may not only appear during testing but also have a real-life impact, affecting academic performance, emotional regulation, and social relationships. For this reason, the study also examines how executive difficulties affect everyday functioning, by collecting information from adolescents themselves, their parents, and the school environment.\n\nFinally, suicidal behaviors in adolescents are influenced by many other factors, particularly psychiatric disorders such as depression, anxiety, and the consequences of traumatic experiences. Depression, in particular, is one of the strongest risk factors for suicide. This study therefore also aims to explore how these psychiatric conditions may influence executive functioning and shape the relationship between cognitive difficulties and suicidal behavior.\n\nBy improving our understanding of these mechanisms, this research seeks to support the development of more effective prevention strategies and better-targeted clinical interventions for adolescents at risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged 11 to 16 years (inclusive), hospitalized at Angers University Hospital in the Child or Adolescent Surgery and Medicine units for the management of suicidal behaviors (suicide attempts and/or suicidal ideation)\n* Covered by the national health insurance system\n* Assent of the adolescent\n* Written informed consent provided by the legal guardians to participate in the study\n\nExclusion Criteria:\n\n* Complete inability to complete the questionnaires (Non-communicative patient; Severe comprehension or communication disorders, Limited or no understanding of the French language)\n* Participation in another interventional study that modifies clinical care\n* Presence of a neurological condition likely to significantly impair cognitive functioning (e.g., epilepsy, brain tumor, neurometabolic disease)\n* Previous inclusion in this study during an earlier hospitalization'}, 'identificationModule': {'nctId': 'NCT07422493', 'acronym': 'SAFE', 'briefTitle': 'Suicidal Behavior in Adolescents and Executive Functions', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Suicidal Behavior in Adolescents and Executive Functions', 'orgStudyIdInfo': {'id': '49RC25_0479'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2025-A02860-49'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adolescents with suicidal behaviors', 'interventionNames': ['Other: Neuropsychological Tests and Psychiatric Tests']}], 'interventions': [{'name': 'Neuropsychological Tests and Psychiatric Tests', 'type': 'OTHER', 'description': 'WISC V Children Executive Functions Battery BRIEF 2 C-SSRS SNAP IV CDI R-CMAS', 'armGroupLabels': ['Adolescents with suicidal behaviors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Elise Riquin, Professor', 'role': 'CONTACT', 'email': 'Elise.Riquin@chu-angers.fr', 'phone': '02 41 35 44 42'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Elise RIQUIN, Professor', 'role': 'CONTACT', 'email': 'Elise.Riquin@chu-angers.fr', 'phone': '02 41 35 44 42'}, {'name': 'Aurélie Hautefort', 'role': 'CONTACT', 'email': 'aurelie.hautefort@chu-angers.fr', 'phone': '0241355899'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Pays de la Loire Laboratory of Psychology (LPPL)', 'class': 'UNKNOWN'}, {'name': 'University of Angers', 'class': 'UNKNOWN'}, {'name': 'Région Pays de la Loire', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}