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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Priscille GERARDIN

Study Contact Backup

Study Locations

  • France
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Rouen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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