- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05525962
Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System. (EvolASE-PEA)
April 8, 2024 updated by: University Hospital, Rouen
Facteurs de vulnérabilité/résilience influençant Les Trajectoires développementales et Les modalités Adaptatives d'Enfants et d'Adolescents confiés à l'Aide Sociale à l'Enfance. Cohorte Primo-arrivants.
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Priscille GERARDIN
Study Contact Backup
- Name: Cécile Pourcher
- Phone Number: 60892 02 32 88 82 65
- Email: cecile.pourcher@chu-rouen.fr
Study Locations
-
-
-
Canteleu, France
- Recruiting
- IDEFHI
-
Contact:
- Wilfried HEROUIN
-
Le Havre, France
- Recruiting
- Centre infantile Raymond Lerch
-
Contact:
- Victorine CORDIER
-
Mont-Saint-Aignan, France
- Recruiting
- Centre hospitalier du Belvédère
-
Contact:
- Catherine LAMOTTE
-
Mont-Saint-Aignan, France
- Recruiting
- Fondation les Nids
-
Contact:
- Alice CHARY
-
Évreux, France
- Recruiting
- Foyer Départementale de l'Enfance
-
Contact:
- Sylvie CHASTAN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 16 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Minor (0 to 16 years old) arriving for the first time in child protective system and present full time
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence and nature of psychiatric disorders according to DSM 5
Time Frame: At inclusion
|
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
|
Presence and nature of psychiatric disorders according to DSM 5
Time Frame: 1 year after inclusion
|
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
|
Presence and nature of psychiatric disorders according to DSM 5
Time Frame: After 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of cognitive abilities
Time Frame: At inclusion
|
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
|
Presence of an attachement psychopathological disorder
Time Frame: At inclusion
|
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
|
Presence of a Borderline-Personality-Disorder
Time Frame: At inclusion
|
Using AbDIB questionnaire from 12 to 18 years old
|
At inclusion
|
Presence of an emotional and behavioral; self-regulation Disorder
Time Frame: At inclusion
|
- 1.5 -18 ans : Child Behavior Checklist (CBCL)
|
At inclusion
|
Presence of an emotional and behavioral; self-regulation Disorder
Time Frame: At inclusion
|
- 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)
|
At inclusion
|
Presence of an emotional and behavioral; self-regulation Disorder
Time Frame: At inclusion
|
- 9-18 ans: Toronto Alexithymia Scale (TAS-20)
|
At inclusion
|
Presence of an emotional and behavioral; self-regulation Disorder
Time Frame: At inclusion
|
- 6-18 ans : Rosenberg self-assessment scale - (RSE)
|
At inclusion
|
Presence of one or multisensory hallucinations
Time Frame: At inclusion
|
6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)
|
At inclusion
|
Mentalization capacities
Time Frame: At inclusion
|
12 to 18 using the Reflective Functioning Questionnaire (RFQ 20)
|
At inclusion
|
Presence of eating disorder
Time Frame: At inclusion
|
2 -18 : SCOFF questionnaire
|
At inclusion
|
Substance use disorders
Time Frame: At inclusion
|
11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)
|
At inclusion
|
Analyses of adverse life events
Time Frame: At inclusion
|
- UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)
|
At inclusion
|
Analyses of adverse life events
Time Frame: At inclusion
|
- 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)
|
At inclusion
|
Description of care pathway
Time Frame: At inclusion
|
using a socio-demographic report (scolarship, medical care and environnement)
|
At inclusion
|
Coping strategies
Time Frame: At inclusion
|
- 12 to 18 years old using the Adolescent Coping Scale (ACS)
|
At inclusion
|
Coping strategies
Time Frame: At inclusion
|
- 7 to 13 years old : Self-Report Coping Scale (SRCS)
|
At inclusion
|
Coping strategies
Time Frame: After 1 year
|
- 12 to 18 years old using the Adolescent Coping Scale (ACS)
|
After 1 year
|
Coping strategies
Time Frame: After 1 year
|
- 7 to 13 years old : Self-Report Coping Scale (SRCS)
|
After 1 year
|
Coping strategies
Time Frame: After 2 years
|
- 12 to 18 years old using the Adolescent Coping Scale (ACS)
|
After 2 years
|
Coping strategies
Time Frame: After 2 years
|
- 7 to 13 years old : Self-Report Coping Scale (SRCS)
|
After 2 years
|
Presence of depressive symptoms
Time Frame: At inclusion
|
12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)
|
At inclusion
|
Analyses of global functionning
Time Frame: At inclusion
|
Using the global assessment functionning
|
At inclusion
|
Analyses of global functionning
Time Frame: At inclusion
|
Using Ages & Stages Questionnaires Version 3 (ASQ3)
|
At inclusion
|
Presence of attachement psychopathological disorder
Time Frame: 1 year after inclusion
|
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
|
Presence of a Borderline-Personality-Disorder
Time Frame: After 1 year
|
Using AbDIB questionnaire from 12 to 18 years old
|
After 1 year
|
Presence of Emotional and behavioral, self-regulation Disorder
Time Frame: 1 year after inclusion
|
- 1.5 -18 ans : Child Behavior Checklist (CBCL)
|
1 year after inclusion
|
Presence of Emotional and behavioral, self-regulation Disorder
Time Frame: 1 year after inclusion
|
- 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)
|
1 year after inclusion
|
Presence of Emotional and behavioral, self-regulation Disorder
Time Frame: 1 year after inclusion
|
- 9-18 ans: Toronto Alexithymia Scale (TAS-20)
|
1 year after inclusion
|
Presence of Emotional and behavioral, self-regulation Disorder
Time Frame: 1 year after inclusion
|
- 6-18 ans : Rosenberg self-assessment scale - (RSE)
|
1 year after inclusion
|
Presence of one or multisensory hallucinations
Time Frame: 1 year after inclusion
|
6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)
|
1 year after inclusion
|
Mentalization capacities
Time Frame: 1 year after inclusion
|
12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)
|
1 year after inclusion
|
Presence of eating disorder
Time Frame: 1 year after inclusion
|
2 -18 : SCOFF questionnaire
|
1 year after inclusion
|
Substance use disorders
Time Frame: 1 year after inclusion
|
11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)
|
1 year after inclusion
|
Analyses of adverse life events
Time Frame: 1 year after inclusion
|
- UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)
|
1 year after inclusion
|
Analyses of adverse life events
Time Frame: 1 year after inclusion
|
- 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)
|
1 year after inclusion
|
Description of care pathway
Time Frame: 1 year after inclusion
|
using a socio-demographic report (scolarship, medical care and environnement)
|
1 year after inclusion
|
Presence of depressive symptoms
Time Frame: 1 year after inclusion
|
12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)
|
1 year after inclusion
|
Analyses of global functionning
Time Frame: 1 year after inclusion
|
Using the global assessment functionning and the Ages & Stages Questionnaires Version 3 (ASQ3)
|
1 year after inclusion
|
Presence of a attachement psychopathological disorder
Time Frame: 2 years after inclusion
|
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
|
Presence of a Borderline-Personality-Disorder
Time Frame: 2 years after inclusion
|
Using AbDIB questionnaire from 12 to 18 years old
|
2 years after inclusion
|
Presence of a Emotional and behavioral self-regulation Disorder
Time Frame: 2 years after inclusion
|
- 1.5 -18 ans : Child Behavior Checklist (CBCL)
|
2 years after inclusion
|
Presence of a Emotional and behavioral self-regulation Disorder
Time Frame: 2 years after inclusion
|
- 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)
|
2 years after inclusion
|
Presence of a Emotional and behavioral self-regulation Disorder
Time Frame: 2 years after inclusion
|
- 9-18 ans: Toronto Alexithymia Scale (TAS-20)
|
2 years after inclusion
|
Presence of a Emotional and behavioral self-regulation Disorder
Time Frame: 2 years after inclusion
|
- 6-18 ans : Rosenberg self-assessment scale - (RSE)
|
2 years after inclusion
|
Presence of one or multisensory hallucinations
Time Frame: 2 years after inclusion
|
- 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)
|
2 years after inclusion
|
Mentalization capacities
Time Frame: 2 years after inclusion
|
12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)
|
2 years after inclusion
|
Presence of eating disorder
Time Frame: 2 years after inclusion
|
2 -18 : SCOFF questionnaire
|
2 years after inclusion
|
Substance use disorders
Time Frame: 2 years after inclusion
|
11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)
|
2 years after inclusion
|
Analyses of adverse life events
Time Frame: 2 years after inclusion
|
- UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)
|
2 years after inclusion
|
Analyses of adverse life events
Time Frame: 2 years after inclusion
|
- 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)
|
2 years after inclusion
|
Analyses of global functionning
Time Frame: 2 years after inclusion
|
Using the global assessment functionning
|
2 years after inclusion
|
Analyses of global functionning
Time Frame: 2 years after inclusion
|
Using the Ages & Stages Questionnaires Version 3 (ASQ3)
|
2 years after inclusion
|
Description of care pathway
Time Frame: 2 years after inclusion
|
using a socio-demographic report (scolarship, medical care and environnement)
|
2 years after inclusion
|
Presence of depressive symptoms
Time Frame: 2 years after inclusion
|
12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)
|
2 years after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2022
Primary Completion (Estimated)
September 29, 2027
Study Completion (Estimated)
September 29, 2027
Study Registration Dates
First Submitted
June 23, 2022
First Submitted That Met QC Criteria
August 30, 2022
First Posted (Actual)
September 2, 2022
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/0219/HP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Development
-
Yale UniversityRobinhood Foundation; Adelphi University; Docs for TotsCompletedSocial Skills | Child Behavior | Child Development | Infant DevelopmentUnited States
-
University of Southern CaliforniaSafe Water and AIDS Project (SWAP); Early Childhood Development Network for...RecruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
London School of Hygiene and Tropical MedicineInternational Centre for Diarrhoeal Disease Research, Bangladesh; University... and other collaboratorsActive, not recruitingChild Development | Child Development DisorderBangladesh, Tanzania, Nepal
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingDevelopment Delay | Development, ChildUnited States
-
The Hospital for Sick ChildrenAga Khan University; March of DimesCompletedChild Development | Child Mortality | Child Morbidity | Child BehaviourPakistan
-
O-KidiaRecruitingChild Development | Child Development DisorderFrance
-
International Centre for Diarrhoeal Disease Research...UnknownChild Behavior | Child DevelopmentBangladesh
-
Boston Medical CenterCenter for the Study of Social PolicyCompletedChild Abuse | Parenting | Child Development | Child Rearing | Child NeglectUnited States
-
University of LiegeActive, not recruitingParent-Child Relations | Child DevelopmentBelgium
Clinical Trials on questionnaries, scales, cognitive tests
-
Eunice Kennedy Shriver National Institute of Child...CompletedGonadal Dysgenesis | Turner's SyndromeUnited States
-
Centre Hospitalier EsquirolCompletedAnorexia NervosaFrance
-
Istituto Auxologico ItalianoIRCCS Istituto Neurologico Carlo BestaRecruitingMultiple Sclerosis | Healthy | Parkinson Disease | Healthy Aging | Peripheral Neuropathy | Rare DiseasesItaly
-
First Hospital of China Medical UniversityNot yet recruitingAlzheimer Disease | Mild Cognitive Impairment
-
Universidad Complutense de MadridUnknownLow Back Pain | Sciatica | Herniated Lumbar Disk
-
Istituto Ortopedico GaleazziNot yet recruitingImmuNe-Mediated Inflammatory DiseasesItaly
-
University Hospital, Strasbourg, FranceInstitut National de la Santé Et de la Recherche Médicale, FranceRecruiting
-
University College, LondonTerminatedDementia | Hearing Loss | Auditory Processing DisorderUnited Kingdom
-
Centre Hospitalier Universitaire de NīmesCompletedDepressive Disorder | Covid19 | Anxiety | Post Traumatic Stress Disorder | Substance Use DisordersFrance
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedParkinson Disease | Alzheimer DiseaseFrance