- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422493
Suicidal Behavior in Adolescents and Executive Functions (SAFE)
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.
Current 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.
Executive 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.
In 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.
The 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.
A 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.
In 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.
Finally, 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.
By 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aurélie Hautefort
- Phone Number: 0241355899
- Email: aurelie.hautefort@chu-angers.fr
Study Contact Backup
- Name: Elise Riquin, Professor
- Phone Number: 02 41 35 44 42
- Email: Elise.Riquin@chu-angers.fr
Study Locations
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-
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Angers, France
- CHU Angers
-
Contact:
- Elise Riquin, Professor
- Phone Number: 02 41 35 44 42
- Email: Elise.Riquin@chu-angers.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- Covered by the national health insurance system
- Assent of the adolescent
- Written informed consent provided by the legal guardians to participate in the study
Exclusion Criteria:
- Complete inability to complete the questionnaires (Non-communicative patient; Severe comprehension or communication disorders, Limited or no understanding of the French language)
- Participation in another interventional study that modifies clinical care
- Presence of a neurological condition likely to significantly impair cognitive functioning (e.g., epilepsy, brain tumor, neurometabolic disease)
- Previous inclusion in this study during an earlier hospitalization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Adolescents with suicidal behaviors
|
WISC V Children Executive Functions Battery BRIEF 2 C-SSRS SNAP IV CDI R-CMAS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of executive functioning impairment in adolescents presenting suicidal behaviors, ranging from suicidal ideation to suicide attempts
Time Frame: Baseline
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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.
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49RC25_0479
- ANSM (Other Identifier: 2024-A02435-42)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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