This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Recruiting
First Posted : September 2, 2022
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date June 23, 2022
First Posted Date September 2, 2022
Last Update Posted Date April 9, 2024
Actual Study Start Date September 29, 2022
Estimated Primary Completion Date September 29, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2022)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 30, 2022)
  • 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
  • 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
  • Presence of a Borderline-Personality-Disorder [ Time Frame: At inclusion ]
    Using AbDIB questionnaire from 12 to 18 years old
  • Presence of an emotional and behavioral; self-regulation Disorder [ Time Frame: At inclusion ]
    - 1.5 -18 ans : Child Behavior Checklist (CBCL)
  • 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)
  • Presence of an emotional and behavioral; self-regulation Disorder [ Time Frame: At inclusion ]
    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)
  • Presence of an emotional and behavioral; self-regulation Disorder [ Time Frame: At inclusion ]
    - 6-18 ans : Rosenberg self-assessment scale - (RSE)
  • Presence of one or multisensory hallucinations [ Time Frame: At inclusion ]
    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)
  • Mentalization capacities [ Time Frame: At inclusion ]
    12 to 18 using the Reflective Functioning Questionnaire (RFQ 20)
  • Presence of eating disorder [ Time Frame: At inclusion ]
    2 -18 : SCOFF questionnaire
  • Substance use disorders [ Time Frame: At inclusion ]
    11 to 18 years old using the Detection of alcohol and drugs problems in adolescent (DepAdo)
  • Analyses of adverse life events [ Time Frame: At inclusion ]
    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)
  • Analyses of adverse life events [ Time Frame: At inclusion ]
    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)
  • Description of care pathway [ Time Frame: At inclusion ]
    using a socio-demographic report (scolarship, medical care and environnement)
  • Coping strategies [ Time Frame: At inclusion ]
    - 12 to 18 years old using the Adolescent Coping Scale (ACS)
  • Coping strategies [ Time Frame: At inclusion ]
    - 7 to 13 years old : Self-Report Coping Scale (SRCS)
  • Coping strategies [ Time Frame: After 1 year ]
    - 12 to 18 years old using the Adolescent Coping Scale (ACS)
  • Coping strategies [ Time Frame: After 1 year ]
    - 7 to 13 years old : Self-Report Coping Scale (SRCS)
  • Coping strategies [ Time Frame: After 2 years ]
    - 12 to 18 years old using the Adolescent Coping Scale (ACS)
  • Coping strategies [ Time Frame: After 2 years ]
    - 7 to 13 years old : Self-Report Coping Scale (SRCS)
  • Presence of depressive symptoms [ Time Frame: At inclusion ]
    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Analyses of global functionning [ Time Frame: At inclusion ]
    Using the global assessment functionning
  • Analyses of global functionning [ Time Frame: At inclusion ]
    Using Ages & Stages Questionnaires Version 3 (ASQ3)
  • 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
  • Presence of a Borderline-Personality-Disorder [ Time Frame: After 1 year ]
    Using AbDIB questionnaire from 12 to 18 years old
  • Presence of Emotional and behavioral, self-regulation Disorder [ Time Frame: 1 year after inclusion ]
    - 1.5 -18 ans : Child Behavior Checklist (CBCL)
  • 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)
  • Presence of Emotional and behavioral, self-regulation Disorder [ Time Frame: 1 year after inclusion ]
    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)
  • Presence of Emotional and behavioral, self-regulation Disorder [ Time Frame: 1 year after inclusion ]
    - 6-18 ans : Rosenberg self-assessment scale - (RSE)
  • Presence of one or multisensory hallucinations [ Time Frame: 1 year after inclusion ]
    6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)
  • Mentalization capacities [ Time Frame: 1 year after inclusion ]
    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)
  • Presence of eating disorder [ Time Frame: 1 year after inclusion ]
    2 -18 : SCOFF questionnaire
  • 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)
  • Analyses of adverse life events [ Time Frame: 1 year after inclusion ]
    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)
  • Analyses of adverse life events [ Time Frame: 1 year after inclusion ]
    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)
  • Description of care pathway [ Time Frame: 1 year after inclusion ]
    using a socio-demographic report (scolarship, medical care and environnement)
  • Presence of depressive symptoms [ Time Frame: 1 year after inclusion ]
    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Analyses of global functionning [ Time Frame: 1 year after inclusion ]
    Using the global assessment functionning and the Ages & Stages Questionnaires Version 3 (ASQ3)
  • 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
  • Presence of a Borderline-Personality-Disorder [ Time Frame: 2 years after inclusion ]
    Using AbDIB questionnaire from 12 to 18 years old
  • Presence of a Emotional and behavioral self-regulation Disorder [ Time Frame: 2 years after inclusion ]
    - 1.5 -18 ans : Child Behavior Checklist (CBCL)
  • 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)
  • Presence of a Emotional and behavioral self-regulation Disorder [ Time Frame: 2 years after inclusion ]
    - 9-18 ans: Toronto Alexithymia Scale (TAS-20)
  • Presence of a Emotional and behavioral self-regulation Disorder [ Time Frame: 2 years after inclusion ]
    - 6-18 ans : Rosenberg self-assessment scale - (RSE)
  • Presence of one or multisensory hallucinations [ Time Frame: 2 years after inclusion ]
    - 6 -18 ans: Multisensory Hallucinations Scale for Children (MHASC)
  • Mentalization capacities [ Time Frame: 2 years after inclusion ]
    12 to 18 years old using the Reflective Functioning Questionnaire (RFQ 20)
  • Presence of eating disorder [ Time Frame: 2 years after inclusion ]
    2 -18 : SCOFF questionnaire
  • 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)
  • Analyses of adverse life events [ Time Frame: 2 years after inclusion ]
    - UCLA Child/Adolescent PTSD Reaction Index (PTSD-UCLA)
  • Analyses of adverse life events [ Time Frame: 2 years after inclusion ]
    - 11 - 18 years old: Childhood Trauma Questionnaire (CTQ)
  • Analyses of global functionning [ Time Frame: 2 years after inclusion ]
    Using the global assessment functionning
  • Analyses of global functionning [ Time Frame: 2 years after inclusion ]
    Using the Ages & Stages Questionnaires Version 3 (ASQ3)
  • Description of care pathway [ Time Frame: 2 years after inclusion ]
    using a socio-demographic report (scolarship, medical care and environnement)
  • Presence of depressive symptoms [ Time Frame: 2 years after inclusion ]
    12-18 years old: Columbia-Suicide Severity Rating Scale (C-SSRS)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
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.
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Behavior, Child
  • Child Development
  • Child Development Disorder
  • Adolescent Development
  • Adolescent Behavior
  • Child Mental Disorder
  • Child Behavior Disorders
  • Adolescent - Emotional Problem
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 30, 2022)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 29, 2027
Estimated Primary Completion Date September 29, 2027   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 16 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Cécile Pourcher 02 32 88 82 65 ext 60892 cecile.pourcher@chu-rouen.fr
Contact: Priscille GERARDIN
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT05525962
Other Study ID Numbers 2021/0219/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University Hospital, Rouen
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Rouen
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Rouen
Verification Date April 2024