Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:28 AM
Study NCT ID:
NCT07430566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trauma Exposure and Suicidal Behaviors in Adolescents Aged 11-17 Hospitalized in Child and Adolescent Psychiatry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative study, monocentric, longitudinal, with follow-up at 6 months'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPC Questionnaire child version', 'timeFrame': 'Baseline', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'CPC questionnaire parents version', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Questionnaire Life Event Checklist (LEC-5)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Schedule for Affective Disorders and Schizophrenia for school-age children (KSADS) full-life version', 'timeFrame': 'Baseline', 'description': 'It is a hetero-administered questionnaire that allows for the screening and diagnosis of psychiatric and neurodevelopmental disorders in children and adolescents.'}, {'measure': 'Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Affective Reactivity Index (ARI)', 'timeFrame': 'Baseline', 'description': 'It is a clinician administered semi-structured scale designed to measure pediatric irritability'}, {'measure': 'Child Youth Resilience Measure (CYRM)', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Adverse Childhood Experiences International Questionnaire (ACE-IQ)', 'timeFrame': 'Baseline', 'description': 'The ACE-IQ evaluates childhood adverse experiences into 29 items and 13 categories of traumatic experiences experienced during childhood.'}, {'measure': 'CER-Q', 'timeFrame': 'Baseline', 'description': 'the CERQ is a self-administered questionnaire which identifies 9 cognitive strategies of emotional regulation into 36 items'}, {'measure': 'BRIEF-2', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Meta-Cognitions Questionnaire for Adolescents (MCQ-A)', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'DES-A', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Neurodevelopmental score', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Screen time', 'timeFrame': 'Baseline', 'description': 'Defined as the time spent per day on a screen (phone, tablet, computer, television), outside of school hours, during weekends, holidays, and public holidays.'}, {'measure': 'Perinatal history : parental psychiatric disorders', 'timeFrame': 'Baseline'}, {'measure': 'Perinatal history : parental age at birth', 'timeFrame': 'Baseline'}, {'measure': 'Perinatal history : perinatal complications', 'timeFrame': 'Baseline'}, {'measure': 'Collection of suicidal behavior', 'timeFrame': '6 months', 'description': 'Direct questioning on the occurrence of suicidal behaviors since the last evaluation, verification of medical records (subsequent admissions to psychiatry for suicide attempt).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['suicide', 'adolescent', 'post-traumatic stress disorder', 'neurodevelopmental disorders', 'résilience', 'biomarqueurs', 'comportements suicidaires'], 'conditions': ['Suicidal Ideation and Behavior', 'Psychiatric Hospitalization']}, 'descriptionModule': {'briefSummary': 'It is a comparative monocentric study with longitudinal follow-up at 6 months in adolescents aged between 11 years and 17 years inclusive admitted to complete hospitalization either for suicidal behaviors or for other psychiatric causes. The objective is to explore the experiences of hospitalized adolescents regarding hospitalization, as well as their perceptions of the factors involved in their remission and their experience of the traumatic event(s) if they have been exposed.', 'detailedDescription': '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.\n\nHypotheses:\n\n* Traumatic exposure is more common among suicidal adolescents than non-suicidal.\n* It is associated with an increased risk of recurrence within 6 months.\n* The neurodevelopmental load, irritability, PTSD and lack of resilience factors modulate this risk.\n* Specific inflammatory biological profiles could be associated with suicidality.\n\nOriginality and innovative aspects:\n\n* Multidimensional approach: clinical, psychometric, biological and qualitative.\n* Constitution of a biobank for future analyses (inflammatory, genetic, epigenetic).\n* Inclusion of a qualitative component exploring the subjective experience of hospitalized adolescents.\n* Integrated analysis of risk, protective and biological factors to guide personalized prevention.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Common Inclusion Criteria:\n\n* Age between 11 and 17 years inclusive\n* Admitted for full-time psychiatric hospitalization\n* Obtaining consent from at least one of the adolescent\'s legal representatives and the adolescent\'s personal assent\n\nInclusion Criteria - "Suicidal Group":\n\n\\- Reason for admission: suicidal behavior (suicide attempt)\n\nInclusion Criteria - "Non-Suicidal Group":\n\n\\- Reason for admission: other psychiatric causes (including suicidal thoughts without suicide attempt and non-suicidal self-injurious behavior)\n\nCommon Exclusion Criteria:\n\n\\- Neither parent available to participate in the intervention\n\nExclusion Criterion - "Non-Suicidal Group":\n\n\\- History of suicidal behavior prior to the current hospitalization'}, 'identificationModule': {'nctId': 'NCT07430566', 'acronym': 'ATTAQ', 'briefTitle': 'Trauma Exposure and Suicidal Behaviors in Adolescents Aged 11-17 Hospitalized in Child and Adolescent Psychiatry', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Trauma Exposure and Suicidal Behaviors in Adolescents Aged 11-17 Hospitalized in Child and Adolescent Psychiatry', 'orgStudyIdInfo': {'id': 'RECHMPL25_0312'}, 'secondaryIdInfos': [{'id': '2025-A02017-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'suicide group', 'description': 'adolescents aged between 11 years old and 17 years inclusive admitted to hospital for suicidal behaviors', 'interventionNames': ['Biological: Blood samples', 'Genetic: genetic analysis', 'Other: Questionnaires and scales']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-suicidal group', 'description': 'aged between 11 years old and 17 years inclusive admitted to hospital for other psychiatric causes without a history of suicidal behavior', 'interventionNames': ['Biological: Blood samples', 'Genetic: genetic analysis', 'Other: Questionnaires and scales']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['non-suicidal group', 'suicide group']}, {'name': 'genetic analysis', 'type': 'GENETIC', 'description': 'If consent for genetic analyses is obtained, a 4.5 mL EDTA tube to collect native DNA will be taken during the blood test', 'armGroupLabels': ['non-suicidal group', 'suicide group']}, {'name': 'Questionnaires and scales', 'type': 'OTHER', 'description': '* Child Posttraumatic Checklist (CPC)\n* Life Event Checklist (LEC-5)\n* Posttraumatic CheckList-5\n* K-SADS\n* Affective Reactivity Index (ARI)\n* Child Youth Resilience Measure\n* Adverse Childhood Experiences International Questionnaire (ACE-IQ)\n* Metacognitions Questionnaire (MCQ-A)\n* Cognitive Emotion Regulation Questionnaire (CERQ)\n* Adolescent Dissociative Experience Scale (A-DES)\n* Behavioral Rating Inventory of Executive Function Self-Report (BRIEF-2)', 'armGroupLabels': ['non-suicidal group', 'suicide group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hala KERBAGE', 'role': 'CONTACT', 'email': 'hala.kerbage@chu-montpellier.fr', 'phone': '0601819449', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}