NCT05525962

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2022Sep 2027

First Submitted

Initial submission to the registry

June 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2027

Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

June 23, 2022

Last Update Submit

April 8, 2024

Conditions

Keywords

childpreschooladolescentpsychiatrypsychologyChild Protective Servicessocial scienceschild protectionsocial servicespsychiatric disordersattachementdevelopmental trajectories

Outcome Measures

Primary Outcomes (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.

    At inclusion

  • 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.

    1 year after inclusion

  • 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.

    After 2 years

Secondary Outcomes (54)

  • Description of cognitive abilities

    At inclusion

  • Presence of an attachement psychopathological disorder

    At inclusion

  • Presence of a Borderline-Personality-Disorder

    At inclusion

  • Presence of an emotional and behavioral; self-regulation Disorder

    At inclusion

  • Presence of an emotional and behavioral; self-regulation Disorder

    At inclusion

  • +49 more secondary outcomes

Interventions

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

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Minor (0 to 16 years old) arriving for the first time in child protective system and present full time

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

IDEFHI

Canteleu, France

RECRUITING

Foyer Départementale de l'Enfance

Évreux, France

RECRUITING

Centre infantile Raymond Lerch

Le Havre, France

RECRUITING

Centre hospitalier du Belvédère

Mont-Saint-Aignan, France

RECRUITING

Fondation les Nids

Mont-Saint-Aignan, France

RECRUITING

MeSH Terms

Conditions

Child BehaviorDevelopmental DisabilitiesAdolescent BehaviorNeurodevelopmental DisordersChild Behavior DisordersMental Disorders

Interventions

Weights and MeasuresNeuropsychological Tests

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Priscille GERARDIN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

September 2, 2022

Study Start

September 29, 2022

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

September 29, 2027

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations