- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07430566
Trauma Exposure and Suicidal Behaviors in Adolescents Aged 11-17 Hospitalized in Child and Adolescent Psychiatry (ATTAQ)
Study Overview
Status
Intervention / Treatment
Detailed Description
Suicidal behaviors among adolescents are a major public health issue. Traumatic exposure (sexual abuse, violence, serious accidents) is a recognized risk factor for psychopathology and suicidality, but its precise links with suicide recurrence, comorbid psychopathology, and neurodevelopmental vulnerability remain little studied.
Hypotheses:
- Traumatic exposure is more common among suicidal adolescents than non-suicidal.
- It is associated with an increased risk of recurrence within 6 months.
- The neurodevelopmental load, irritability, PTSD and lack of resilience factors modulate this risk.
- Specific inflammatory biological profiles could be associated with suicidality.
Originality and innovative aspects:
- Multidimensional approach: clinical, psychometric, biological and qualitative.
- Constitution of a biobank for future analyses (inflammatory, genetic, epigenetic).
- Inclusion of a qualitative component exploring the subjective experience of hospitalized adolescents.
- Integrated analysis of risk, protective and biological factors to guide personalized prevention.
The main objective is to compare the frequency of traumatic exposure history evaluated with the validated questionnaire in French of the CPC version child, among adolescents aged between 11 years old and 17 years inclusive admitted to hospital, either for suicidal behaviors (suicide group), either for other psychiatric causes without a history of suicidal behavior (non-suicidal group).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hala KERBAGE
- Phone Number: +33 0601819449
- Email: hala.kerbage@chu-montpellier.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Common Inclusion Criteria:
- Age between 11 and 17 years inclusive
- Admitted for full-time psychiatric hospitalization
- Obtaining consent from at least one of the adolescent's legal representatives and the adolescent's personal assent
Inclusion Criteria - "Suicidal Group":
- Reason for admission: suicidal behavior (suicide attempt)
Inclusion Criteria - "Non-Suicidal Group":
- Reason for admission: other psychiatric causes (including suicidal thoughts without suicide attempt and non-suicidal self-injurious behavior)
Common Exclusion Criteria:
- Neither parent available to participate in the intervention
Exclusion Criterion - "Non-Suicidal Group":
- History of suicidal behavior prior to the current hospitalization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: suicide group
adolescents aged between 11 years old and 17 years inclusive admitted to hospital for suicidal behaviors
|
A blood test will be carried out during the inclusion visit, on site, with collection of the time of completion, the last food samples and tobacco consumption.
A 2.5 mL Paxgene® tube for whole blood RNA and a 5 mL dry tube for serum will be collected.
If consent for genetic analyses is obtained, a 4.5 mL EDTA tube to collect native DNA will be taken during the blood test
|
|
Active Comparator: non-suicidal group
aged between 11 years old and 17 years inclusive admitted to hospital for other psychiatric causes without a history of suicidal behavior
|
A blood test will be carried out during the inclusion visit, on site, with collection of the time of completion, the last food samples and tobacco consumption.
A 2.5 mL Paxgene® tube for whole blood RNA and a 5 mL dry tube for serum will be collected.
If consent for genetic analyses is obtained, a 4.5 mL EDTA tube to collect native DNA will be taken during the blood test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPC Questionnaire child version
Time Frame: Baseline
|
This questionnaire evaluates the symptoms of PTSD and their frequency in children aged 7 to 18 years, following a traumatic event.
Completion time is 15-20 minutes and the total score can range from 0 (no symptoms) to 84 (maximum symptoms) for symptom intensity and from 0 (no functional impact) to 24 (maximum functional impact) for functional impairment.
The scale will be administered by a clinician (psychologist or psychiatrist for children and adolescents).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPC questionnaire parents version
Time Frame: Baseline
|
This questionnaire evaluates by parents the symptoms of their children in PTSD and their frequency in children aged 7 to 18 years, following a traumatic event.
Completion time is 15-20 minutes and the total score can range from 0 (no symptoms) to 84 (maximum symptoms) for symptom intensity and from 0 (no functional impact) to 24 (maximum functional impact) for functional impairment.
The scale will be administered by a clinician or self-administered (psychologist or psychiatrist for children and adolescents).
|
Baseline
|
|
Questionnaire Life Event Checklist (LEC-5)
Time Frame: Baseline
|
The Life Event Checklist version of DSM-5 (19) consists of a list of 16 potentially trauma events in reference to criterion 1 of PTSD from DSM-5.
It does not generate a total score but allows for a record of trauma events if they have occurred or not.
|
Baseline
|
|
Schedule for Affective Disorders and Schizophrenia for school-age children (KSADS) full-life version
Time Frame: Baseline
|
It is a hetero-administered questionnaire that allows for the screening and diagnosis of psychiatric and neurodevelopmental disorders in children and adolescents.
|
Baseline
|
|
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Baseline
|
The PCL-5 (23) is composed of 20 items that correspond to the 20 PTSD criteria detailed in the DSM-5, and contains four subscales corresponding to the four clusters of symptoms in the DSM-5: intrusion phenomena, avoidance, negative alterations of cognition and mood, and increase in hyperactivity and reactivity.
The score can range from 0 (no symptoms) to 80 (maximum symptoms).
PCL-5 is a self-administered questionnaire that can also be administered with the help of a clinician.
|
Baseline
|
|
Affective Reactivity Index (ARI)
Time Frame: Baseline
|
It is a clinician administered semi-structured scale designed to measure pediatric irritability
|
Baseline
|
|
Child Youth Resilience Measure (CYRM)
Time Frame: Baseline
|
The CHYRM (26) is a scale used to measure social and family support and child skills.
The child version is in two versions: one for 7-10 years old and one for 11-18 years old.
There is also a version to be completed by the parents on their perception of social and family support and skills of the child (one for 7-10 years old and one for 11-18 years old).
|
Baseline
|
|
Adverse Childhood Experiences International Questionnaire (ACE-IQ)
Time Frame: Baseline
|
The ACE-IQ evaluates childhood adverse experiences into 29 items and 13 categories of traumatic experiences experienced during childhood.
|
Baseline
|
|
CER-Q
Time Frame: Baseline
|
the CERQ is a self-administered questionnaire which identifies 9 cognitive strategies of emotional regulation into 36 items
|
Baseline
|
|
BRIEF-2
Time Frame: Baseline
|
The BRIEF-2 is a scale assessing daily behaviors at school and home, related to the executive functions of children between 5 and 17 years.
The self-reported questionnaire takes about 10 minutes to complete.
|
Baseline
|
|
Meta-Cognitions Questionnaire for Adolescents (MCQ-A)
Time Frame: Baseline
|
This tool consisting of 30 items highlights five sub-dimensions of metacognition: excessive monitoring, non-trust in one's memory, negative metacognitive beliefs related to superstition, negative and positive metacognitive beliefs.
|
Baseline
|
|
DES-A
Time Frame: Baseline
|
The DES-A is a self-reported questionnaire in 30 items allowing to detect different dissociative phenomena in teenagers between 11 and 17 years old.
A total score corresponding to the severity of dissociative behaviors is obtained by adding the scores of each item.The minimum score is 1 and the maximum 10.
|
Baseline
|
|
Neurodevelopmental score
Time Frame: Baseline
|
Neurodevelopmental burden calculated using the neurodevelopmental score: maternal age, paternal age, presence of ADHD, specific learning disorders, bipolar disorder before age 15, eating disorder (ED) before age 15, anxiety disorder before age 15, substance use disorder (SUD) before age 15, traumatic exposure.
ADHD, specific learning disorders, bipolar disorder, ED, anxiety disorder, and SUD are diagnosed using the K-SADS.
|
Baseline
|
|
Screen time
Time Frame: Baseline
|
Defined as the time spent per day on a screen (phone, tablet, computer, television), outside of school hours, during weekends, holidays, and public holidays.
|
Baseline
|
|
Perinatal history : parental psychiatric disorders
Time Frame: Baseline
|
Baseline
|
|
|
Perinatal history : parental age at birth
Time Frame: Baseline
|
Baseline
|
|
|
Perinatal history : perinatal complications
Time Frame: Baseline
|
Baseline
|
|
|
Collection of suicidal behavior
Time Frame: 6 months
|
Direct questioning on the occurrence of suicidal behaviors since the last evaluation, verification of medical records (subsequent admissions to psychiatry for suicide attempt).
|
6 months
|
Collaborators and Investigators
Sponsor
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
- Trauma and Stressor Related Disorders
- Mental Disorders
- Behavioral Symptoms
- Self-Injurious Behavior
- Stress Disorders, Traumatic
- Suicide
- Suicidal Ideation
- Neurodevelopmental Disorders
- Stress Disorders, Post-Traumatic
- Behavior
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Preventive Health Services
- Genetic Techniques
- Genetic Services
- Diagnostic Services
- Weights and Measures
- Surveys and Questionnaires
- Genetic Testing
- Blood Specimen Collection
Other Study ID Numbers
- RECHMPL25_0312
- 2025-A02017-42 (Other Identifier: ANSM)
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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