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RecruitingNCT05525962EvolASE-PEAUpdated Apr 9, 2024

Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.

An observational study in Behavior, Child, Child Development and Child Development Disorder, sponsored by University Hospital, Rouen. Recruiting at 5 sites in France. Open to participants aged Up to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by University Hospital, Rouen · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
Up to 16 Years
Sex
All
01

Study 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

02

Conditions studied

  • Behavior, Child
  • Child Development
  • Child Development Disorder
  • Adolescent Development
  • Adolescent Behavior
  • Child Mental Disorder
  • Child Behavior Disorders
  • Adolescent - Emotional Problem

Keywords

  • child
  • preschool
  • adolescent
  • psychiatry
  • psychology
  • Child Protective Services
  • social sciences
  • child protection
  • social services
  • psychiatric disorders
  • attachement
  • developmental trajectories
03

In context

Child Behavior

224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 25 observational studies indexed under Child Behavior.

Browse Child Behavior studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Browse University Hospital, Rouen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Minor adressed to child protective services
  • Minor placed full time

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • Behavioralquestionnaries, 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At inclusion

  2. 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.

    Time frame: 1 year after inclusion

  3. 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.

    Time frame: After 2 years

Secondary outcomes

  1. 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

    Time frame: At inclusion

  2. 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

    Time frame: At inclusion

  3. Presence of a Borderline-Personality-Disorder

    Using AbDIB questionnaire from 12 to 18 years old

    Time frame: At inclusion

  4. Presence of an emotional and behavioral; self-regulation Disorder

    - 1.5 -18 ans : Child Behavior Checklist (CBCL)

    Time frame: At inclusion

  5. Presence of an emotional and behavioral; self-regulation Disorder

    - 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)

    Time frame: At inclusion

  6. Presence of an emotional and behavioral; self-regulation Disorder

    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)

    Time frame: At inclusion

  7. Presence of an emotional and behavioral; self-regulation Disorder

    - 6-18 ans : Rosenberg self-assessment scale - (RSE)

    Time frame: At inclusion

  8. Presence of one or multisensory hallucinations

    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

    Time frame: At inclusion

  9. Mentalization capacities

    12 to 18 using the Reflective Functioning Questionnaire (RFQ 20)

    Time frame: At inclusion

  10. Presence of eating disorder

    2 -18 : SCOFF questionnaire

    Time frame: At inclusion

  11. Substance use disorders

    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)

    Time frame: At inclusion

  12. Analyses of adverse life events

    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

    Time frame: At inclusion

  13. Analyses of adverse life events

    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

    Time frame: At inclusion

  14. Description of care pathway

    using a socio-demographic report (scolarship, medical care and environnement)

    Time frame: At inclusion

  15. Coping strategies

    - 12 to 18 years old using the Adolescent Coping Scale (ACS)

    Time frame: At inclusion

  16. Coping strategies

    - 7 to 13 years old : Self-Report Coping Scale (SRCS)

    Time frame: At inclusion

  17. Coping strategies

    - 12 to 18 years old using the Adolescent Coping Scale (ACS)

    Time frame: After 1 year

  18. Coping strategies

    - 7 to 13 years old : Self-Report Coping Scale (SRCS)

    Time frame: After 1 year

  19. Coping strategies

    - 12 to 18 years old using the Adolescent Coping Scale (ACS)

    Time frame: After 2 years

  20. Coping strategies

    - 7 to 13 years old : Self-Report Coping Scale (SRCS)

    Time frame: After 2 years

  21. Presence of depressive symptoms

    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: At inclusion

  22. Analyses of global functionning

    Using the global assessment functionning

    Time frame: At inclusion

  23. Analyses of global functionning

    Using Ages \& Stages Questionnaires Version 3 (ASQ3)

    Time frame: At inclusion

  24. 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

    Time frame: 1 year after inclusion

  25. Presence of a Borderline-Personality-Disorder

    Using AbDIB questionnaire from 12 to 18 years old

    Time frame: After 1 year

  26. Presence of Emotional and behavioral, self-regulation Disorder

    - 1.5 -18 ans : Child Behavior Checklist (CBCL)

    Time frame: 1 year after inclusion

  27. Presence of Emotional and behavioral, self-regulation Disorder

    - 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)

    Time frame: 1 year after inclusion

  28. Presence of Emotional and behavioral, self-regulation Disorder

    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)

    Time frame: 1 year after inclusion

  29. Presence of Emotional and behavioral, self-regulation Disorder

    - 6-18 ans : Rosenberg self-assessment scale - (RSE)

    Time frame: 1 year after inclusion

  30. Presence of one or multisensory hallucinations

    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

    Time frame: 1 year after inclusion

  31. Mentalization capacities

    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)

    Time frame: 1 year after inclusion

  32. Presence of eating disorder

    2 -18 : SCOFF questionnaire

    Time frame: 1 year after inclusion

  33. Substance use disorders

    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)

    Time frame: 1 year after inclusion

  34. Analyses of adverse life events

    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

    Time frame: 1 year after inclusion

  35. Analyses of adverse life events

    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

    Time frame: 1 year after inclusion

  36. Description of care pathway

    using a socio-demographic report (scolarship, medical care and environnement)

    Time frame: 1 year after inclusion

  37. Presence of depressive symptoms

    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: 1 year after inclusion

  38. Analyses of global functionning

    Using the global assessment functionning and the Ages \& Stages Questionnaires Version 3 (ASQ3)

    Time frame: 1 year after inclusion

  39. 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

    Time frame: 2 years after inclusion

  40. Presence of a Borderline-Personality-Disorder

    Using AbDIB questionnaire from 12 to 18 years old

    Time frame: 2 years after inclusion

  41. Presence of a Emotional and behavioral self-regulation Disorder

    - 1.5 -18 ans : Child Behavior Checklist (CBCL)

    Time frame: 2 years after inclusion

  42. Presence of a Emotional and behavioral self-regulation Disorder

    - 6-18 ans : Affective Reactivity Index Child Report and Parent Report (ARI)

    Time frame: 2 years after inclusion

  43. Presence of a Emotional and behavioral self-regulation Disorder

    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)

    Time frame: 2 years after inclusion

  44. Presence of a Emotional and behavioral self-regulation Disorder

    - 6-18 ans : Rosenberg self-assessment scale - (RSE)

    Time frame: 2 years after inclusion

  45. Presence of one or multisensory hallucinations

    - 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

    Time frame: 2 years after inclusion

  46. Mentalization capacities

    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)

    Time frame: 2 years after inclusion

  47. Presence of eating disorder

    2 -18 : SCOFF questionnaire

    Time frame: 2 years after inclusion

  48. Substance use disorders

    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)

    Time frame: 2 years after inclusion

  49. Analyses of adverse life events

    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

    Time frame: 2 years after inclusion

  50. Analyses of adverse life events

    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

    Time frame: 2 years after inclusion

  51. Analyses of global functionning

    Using the global assessment functionning

    Time frame: 2 years after inclusion

  52. Analyses of global functionning

    Using the Ages \& Stages Questionnaires Version 3 (ASQ3)

    Time frame: 2 years after inclusion

  53. Description of care pathway

    using a socio-demographic report (scolarship, medical care and environnement)

    Time frame: 2 years after inclusion

  54. Presence of depressive symptoms

    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: 2 years after inclusion

07

Study locations

5 of 5 sites recruiting
  • IDEFHI
    Canteleu, France
    Recruiting
    • Wilfried HEROUIN · Contact
  • Centre infantile Raymond Lerch
    Le Havre, France
    Recruiting
    • Victorine CORDIER · Contact
  • Centre hospitalier du Belvédère
    Mont-Saint-Aignan, France
    Recruiting
    • Catherine LAMOTTE · Contact
  • Fondation les Nids
    Mont-Saint-Aignan, France
    Recruiting
    • Alice CHARY · Contact
  • Foyer Départementale de l'Enfance
    Évreux, France
    Recruiting
    • Sylvie CHASTAN · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2022 (actual). Primary completion is estimated for Sep 2027, 60 months after the start.

Of 14 observational studies under Child Behavior, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 32. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2022
First posted
Sep 2, 2022
StartActual
Sep 29, 2022
Primary completionEst.
Sep 29, 2027
CompletionEst.
Sep 29, 2027
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05525962
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Sep 29, 2022
Primary completion
Sep 29, 2027 (estimated)
Completion
Sep 29, 2027 (estimated)
Last update
Apr 9, 2024

Study contacts

Cécile Pourcher
Contact
cecile.pourcher@chu-rouen.fr
02 32 88 82 65 ext. 60892
Priscille GERARDIN
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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