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Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System. (EvolASE-PEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05525962
Recruitment Status : Not yet recruiting
First Posted : September 2, 2022
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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

Condition or disease Intervention/treatment
Behavior, Child Child Development Child Development Disorder Adolescent Development Adolescent Behavior Child Mental Disorder Child Behavior Disorders Adolescent - Emotional Problem Behavioral: questionnaries, scales, cognitive tests

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : July 1, 2027
Estimated Study Completion Date : July 1, 2027

Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Presence of a Borderline-Personality-Disorder [ Time Frame: At inclusion ]
    Using AbDIB questionnaire from 12 to 18 years old

  4. Presence of an emotional and behavioral; self-regulation Disorder [ Time Frame: At inclusion ]
    - 1.5 -18 ans : Child Behavior Checklist (CBCL)

  5. 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)

  6. Presence of an emotional and behavioral; self-regulation Disorder [ Time Frame: At inclusion ]
    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)

  7. Presence of an emotional and behavioral; self-regulation Disorder [ Time Frame: At inclusion ]
    - 6-18 ans : Rosenberg self-assessment scale - (RSE)

  8. Presence of one or multisensory hallucinations [ Time Frame: At inclusion ]
    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

  9. Mentalization capacities [ Time Frame: At inclusion ]
    12 to 18 using the Reflective Functioning Questionnaire (RFQ 20)

  10. Presence of eating disorder [ Time Frame: At inclusion ]
    2 -18 : SCOFF questionnaire

  11. Substance use disorders [ Time Frame: At inclusion ]
    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)

  12. Analyses of adverse life events [ Time Frame: At inclusion ]
    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

  13. Analyses of adverse life events [ Time Frame: At inclusion ]
    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

  14. Description of care pathway [ Time Frame: At inclusion ]
    using a socio-demographic report (scolarship, medical care and environnement)

  15. Coping strategies [ Time Frame: At inclusion ]
    - 12 to 18 years old using the Adolescent Coping Scale (ACS)

  16. Coping strategies [ Time Frame: At inclusion ]
    - 7 to 13 years old : Self-Report Coping Scale (SRCS)

  17. Coping strategies [ Time Frame: After 1 year ]
    - 12 to 18 years old using the Adolescent Coping Scale (ACS)

  18. Coping strategies [ Time Frame: After 1 year ]
    - 7 to 13 years old : Self-Report Coping Scale (SRCS)

  19. Coping strategies [ Time Frame: After 2 years ]
    - 12 to 18 years old using the Adolescent Coping Scale (ACS)

  20. Coping strategies [ Time Frame: After 2 years ]
    - 7 to 13 years old : Self-Report Coping Scale (SRCS)

  21. Presence of depressive symptoms [ Time Frame: At inclusion ]
    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

  22. Analyses of global functionning [ Time Frame: At inclusion ]
    Using the global assessment functionning

  23. Analyses of global functionning [ Time Frame: At inclusion ]
    Using Ages & Stages Questionnaires Version 3 (ASQ3)

  24. 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

  25. Presence of a Borderline-Personality-Disorder [ Time Frame: After 1 year ]
    Using AbDIB questionnaire from 12 to 18 years old

  26. Presence of Emotional and behavioral, self-regulation Disorder [ Time Frame: 1 year after inclusion ]
    - 1.5 -18 ans : Child Behavior Checklist (CBCL)

  27. 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)

  28. Presence of Emotional and behavioral, self-regulation Disorder [ Time Frame: 1 year after inclusion ]
    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)

  29. Presence of Emotional and behavioral, self-regulation Disorder [ Time Frame: 1 year after inclusion ]
    - 6-18 ans : Rosenberg self-assessment scale - (RSE)

  30. Presence of one or multisensory hallucinations [ Time Frame: 1 year after inclusion ]
    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

  31. Mentalization capacities [ Time Frame: 1 year after inclusion ]
    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)

  32. Presence of eating disorder [ Time Frame: 1 year after inclusion ]
    2 -18 : SCOFF questionnaire

  33. 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)

  34. Analyses of adverse life events [ Time Frame: 1 year after inclusion ]
    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

  35. Analyses of adverse life events [ Time Frame: 1 year after inclusion ]
    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

  36. Description of care pathway [ Time Frame: 1 year after inclusion ]
    using a socio-demographic report (scolarship, medical care and environnement)

  37. Presence of depressive symptoms [ Time Frame: 1 year after inclusion ]
    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)

  38. Analyses of global functionning [ Time Frame: 1 year after inclusion ]
    Using the global assessment functionning and the Ages & Stages Questionnaires Version 3 (ASQ3)

  39. 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

  40. Presence of a Borderline-Personality-Disorder [ Time Frame: 2 years after inclusion ]
    Using AbDIB questionnaire from 12 to 18 years old

  41. Presence of a Emotional and behavioral self-regulation Disorder [ Time Frame: 2 years after inclusion ]
    - 1.5 -18 ans : Child Behavior Checklist (CBCL)

  42. 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)

  43. Presence of a Emotional and behavioral self-regulation Disorder [ Time Frame: 2 years after inclusion ]
    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)

  44. Presence of a Emotional and behavioral self-regulation Disorder [ Time Frame: 2 years after inclusion ]
    - 6-18 ans : Rosenberg self-assessment scale - (RSE)

  45. Presence of one or multisensory hallucinations [ Time Frame: 2 years after inclusion ]
    - 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)

  46. Mentalization capacities [ Time Frame: 2 years after inclusion ]
    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)

  47. Presence of eating disorder [ Time Frame: 2 years after inclusion ]
    2 -18 : SCOFF questionnaire

  48. 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)

  49. Analyses of adverse life events [ Time Frame: 2 years after inclusion ]
    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)

  50. Analyses of adverse life events [ Time Frame: 2 years after inclusion ]
    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)

  51. Analyses of global functionning [ Time Frame: 2 years after inclusion ]
    Using the global assessment functionning

  52. Analyses of global functionning [ Time Frame: 2 years after inclusion ]
    Using the Ages & Stages Questionnaires Version 3 (ASQ3)

  53. Description of care pathway [ Time Frame: 2 years after inclusion ]
    using a socio-demographic report (scolarship, medical care and environnement)

  54. Presence of depressive symptoms [ Time Frame: 2 years after inclusion ]
    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05525962


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

Sponsors and Collaborators
University Hospital, Rouen
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT05525962    
Other Study ID Numbers: 2021/0219/HP
First Posted: September 2, 2022    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
child
preschool
adolescent
psychiatry
psychology
Child Protective Services
social sciences
child protection
social services
psychiatric disorders
attachement
developmental trajectories
Additional relevant MeSH terms:
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Mental Disorders
Developmental Disabilities
Child Behavior Disorders
Neurodevelopmental Disorders