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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05690113
Other study ID # 69HCL22_0390
Secondary ID 2022-A02018-35_2
Status Completed
Phase
First received
Last updated
Start date February 3, 2023
Est. completion date March 9, 2024

Study information

Verified date June 2024
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Child psychotraumatism and complex psychotraumatism, mainly consecutive to child maltreatment, is a major unaddressed public health issue. The investigators aim to translate and validate a screening scale to help professionals to better detect and refer children at risk of psychotraumatism. This study aims to validate the psychometric properties of a french version of the CATS 2.0, in partnership with the original authors of the scale.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date March 9, 2024
Est. primary completion date March 9, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria: - child aged between 7 and 17 - at least an adult of reference (parent or tutor) reachable - agreement of adult of reference - for clinical population : have been potentially exposed to a potential traumatic event (according to DSM-V) Exclusion Criteria: - non-mastery of French language

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CATS scale
During the inclusion visit (J0), enrolled children will complete the CATS scale as well as the SCARED (Screen for Child Anxiety and Related Disorders). Their parents will also complete the CATS and the SDQ (Strength and Difficulties Questionnaire).

Locations

Country Name City State
France Service de Psychopathologie de l'Enfant et l'Adolescent, Hôpital Femme Mère Enfant Bron
France Laboratoire de Psychologie et de NeuroCognition, Domaine Universitaire de Jacob Bellecombette Chambéry
France Centre Régional de Psychotraumatisme, Hôpital Edouard Herriot Lyon
France Service de Médecine Légale, Hôpital Edouard Herriot Lyon
France Centre d'Evaluation de Psychotraumatisme Pédiatrique, CHU Lenval Nice
France Centre Psychotrauma Grand Est Alsace Nord, Hôpital civil et hôpital de l'Elsau Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychometric properties of the Children and Adolescent Trauma Screen (CATS) scale Construct validity (structural validity, convergent-divergent validity), intraclass correlation coefficients, and internal consistency analysis will be performed. Day 0 (D0)
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