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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05525962
Other study ID # 2021/0219/HP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 29, 2022
Est. completion date September 29, 2027

Study information

Verified date April 2024
Source University Hospital, Rouen
Contact Cécile Pourcher
Phone 02 32 88 82 65
Email cecile.pourcher@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assess the prevalence of medico-psychological characteristics at the time of placement (M0), their appearance / disappearance and during the two years following placement (M12 and M24) by age group in children / adolescents in Child Protective Services and placed full-time in the structures of Seine-Maritime and Eure as well as in nursery in Le Havre or Rouen


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 29, 2027
Est. primary completion date September 29, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 16 Years
Eligibility Inclusion Criteria: - Minor adressed to child protective services - Minor placed full time Exclusion Criteria: - Non affiliation to social security system - Non accompanied minor - Minor and/or parfents not understanding french - Minor informed and refused participation - Parents or tutor having refused participation of their child

Study Design


Intervention

Behavioral:
questionnaries, scales, cognitive tests
A first interview is planned with a psycholgist in the weeks following the minor arrival in the structure (M0) M0: cognitive test, psychiatric classification and psychologic assessments M12 and M24: psychiatric classification and psychologic assessments

Locations

Country Name City State
France IDEFHI Canteleu
France Foyer Départementale de l'Enfance Évreux
France Centre infantile Raymond Lerch Le Havre
France Centre hospitalier du Belvédère Mont-Saint-Aignan
France Fondation les Nids Mont-Saint-Aignan

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence and nature of psychiatric disorders according to DSM 5 assessed by MINI S-KID (International Neuropsychiatric Interview for Children and Adolescents) for 6-18 year olds and DC 0-5 (Diagnostic Classification from 0 to 5 ) for 0 to 5 year olds. At inclusion
Primary Presence and nature of psychiatric disorders according to DSM 5 assessed by MINI S-KID (International Neuropsychiatric Interview for Children and Adolescents) for 6-18 year olds and DC 0-5 (Diagnostic Classification from 0 to 5 ) for 0 to 5 year olds. 1 year after inclusion
Primary Presence and nature of psychiatric disorders according to DSM 5 assessed by MINI S-KID (International Neuropsychiatric Interview for Children and Adolescents) for 6-18 year olds and DC 0-5 (Diagnostic Classification from 0 to 5 ) for 0 to 5 year olds. After 2 years
Secondary Description of cognitive abilities 0 to 2 years old : BAYLEY V3 or Brunet Lezine (revised) 3 to 6 years old : WPPSI-IV 7 to 16 years old : WISC-V 16 to 18 years old : WAIS-V At inclusion
Secondary Presence of an attachement psychopathological disorder Assessed by the strange situation procedure for participants aged from 9 months old to 3 years old Assessed by Attachment story completion test from 4 to 9 years old Assessed by the Inventory of Parents and Peer Attachement from 10 to 18 years old At inclusion
Secondary Presence of a Borderline-Personality-Disorder Using AbDIB questionnaire from 12 to 18 years old At inclusion
Secondary Presence of an emotional and behavioral; self-regulation Disorder - 1.5 -18 ans : Child Behavior Checklist (CBCL) At inclusion
Secondary Presence of an emotional and behavioral; self-regulation Disorder - 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI) At inclusion
Secondary Presence of an emotional and behavioral; self-regulation Disorder - 9-18 ans: Toronto Alexithymia Scale (TAS-20) At inclusion
Secondary Presence of an emotional and behavioral; self-regulation Disorder - 6-18 ans : Rosenberg self-assessment scale - (RSE) At inclusion
Secondary Presence of one or multisensory hallucinations 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC) At inclusion
Secondary Mentalization capacities 12 to 18 using the Reflective Functioning Questionnaire (RFQ 20) At inclusion
Secondary Presence of eating disorder 2 -18 : SCOFF questionnaire At inclusion
Secondary Substance use disorders 11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo) At inclusion
Secondary Analyses of adverse life events - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA) At inclusion
Secondary Analyses of adverse life events - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ) At inclusion
Secondary Description of care pathway using a socio-demographic report (scolarship, medical care and environnement) At inclusion
Secondary Coping strategies - 12 to 18 years old using the Adolescent Coping Scale (ACS) At inclusion
Secondary Coping strategies - 7 to 13 years old : Self-Report Coping Scale (SRCS) At inclusion
Secondary Coping strategies - 12 to 18 years old using the Adolescent Coping Scale (ACS) After 1 year
Secondary Coping strategies - 7 to 13 years old : Self-Report Coping Scale (SRCS) After 1 year
Secondary Coping strategies - 12 to 18 years old using the Adolescent Coping Scale (ACS) After 2 years
Secondary Coping strategies - 7 to 13 years old : Self-Report Coping Scale (SRCS) After 2 years
Secondary Presence of depressive symptoms 12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS) At inclusion
Secondary Analyses of global functionning Using the global assessment functionning At inclusion
Secondary Analyses of global functionning Using Ages & Stages Questionnaires Version 3 (ASQ3) At inclusion
Secondary Presence of attachement psychopathological disorder Assessed by the strange situation procedure for participants aged from 9 months old to 3 years old Assessed by Attachment story completion test from 4 to 9 years old Assessed by the Inventory of Parents and Peer Attachement from 10 to 18 years old 1 year after inclusion
Secondary Presence of a Borderline-Personality-Disorder Using AbDIB questionnaire from 12 to 18 years old After 1 year
Secondary Presence of Emotional and behavioral, self-regulation Disorder - 1.5 -18 ans : Child Behavior Checklist (CBCL) 1 year after inclusion
Secondary Presence of Emotional and behavioral, self-regulation Disorder - 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI) 1 year after inclusion
Secondary Presence of Emotional and behavioral, self-regulation Disorder - 9-18 ans: Toronto Alexithymia Scale (TAS-20) 1 year after inclusion
Secondary Presence of Emotional and behavioral, self-regulation Disorder - 6-18 ans : Rosenberg self-assessment scale - (RSE) 1 year after inclusion
Secondary Presence of one or multisensory hallucinations 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC) 1 year after inclusion
Secondary Mentalization capacities 12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20) 1 year after inclusion
Secondary Presence of eating disorder 2 -18 : SCOFF questionnaire 1 year after inclusion
Secondary Substance use disorders 11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo) 1 year after inclusion
Secondary Analyses of adverse life events - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA) 1 year after inclusion
Secondary Analyses of adverse life events - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ) 1 year after inclusion
Secondary Description of care pathway using a socio-demographic report (scolarship, medical care and environnement) 1 year after inclusion
Secondary Presence of depressive symptoms 12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS) 1 year after inclusion
Secondary Analyses of global functionning Using the global assessment functionning and the Ages & Stages Questionnaires Version 3 (ASQ3) 1 year after inclusion
Secondary Presence of a attachement psychopathological disorder Assessed by the strange situation procedure for participants aged from 9 months old to 3 years old Assessed by Attachment story completion test from 4 to 9 years old Assessed by the Inventory of Parents and Peer Attachement from 10 to 18 years old 2 years after inclusion
Secondary Presence of a Borderline-Personality-Disorder Using AbDIB questionnaire from 12 to 18 years old 2 years after inclusion
Secondary Presence of a Emotional and behavioral self-regulation Disorder - 1.5 -18 ans : Child Behavior Checklist (CBCL) 2 years after inclusion
Secondary Presence of a Emotional and behavioral self-regulation Disorder - 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI) 2 years after inclusion
Secondary Presence of a Emotional and behavioral self-regulation Disorder - 9-18 ans: Toronto Alexithymia Scale (TAS-20) 2 years after inclusion
Secondary Presence of a Emotional and behavioral self-regulation Disorder - 6-18 ans : Rosenberg self-assessment scale - (RSE) 2 years after inclusion
Secondary Presence of one or multisensory hallucinations - 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC) 2 years after inclusion
Secondary Mentalization capacities 12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20) 2 years after inclusion
Secondary Presence of eating disorder 2 -18 : SCOFF questionnaire 2 years after inclusion
Secondary Substance use disorders 11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo) 2 years after inclusion
Secondary Analyses of adverse life events - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA) 2 years after inclusion
Secondary Analyses of adverse life events - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ) 2 years after inclusion
Secondary Analyses of global functionning Using the global assessment functionning 2 years after inclusion
Secondary Analyses of global functionning Using the Ages & Stages Questionnaires Version 3 (ASQ3) 2 years after inclusion
Secondary Description of care pathway using a socio-demographic report (scolarship, medical care and environnement) 2 years after inclusion
Secondary Presence of depressive symptoms 12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS) 2 years after inclusion
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