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Recruiting Observational

Prospective Cohort Study of Protected Children

NCT06805682 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-02-18
Last updated
2026-04-13

Condition(s) studied

Mental Health ConditionsPhysical Health StatusChild Development

Investigational drug(s) / intervention(s)

Usual Care

Usual Care: Children will be followed using each CPS participating center's usual practices

Study summary

A significant number of children are abused or neglected every year. This exposure is associated with short- and long-term consequences for their mental and somatic health. In France, 308,000 minors are benefiting from at least one child protective service or measure. There are few data on the health status of this population, and how it is evolving. Against this backdrop, interventions are needed to address the many needs of these children early and comprehensively, both in the short and long term.

The PEGASE program, funded by the French government under Article 51, aims to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS). An evaluation of the program's effectiveness and efficiency is needed to inform public decision-making on the appropriateness of extending it to all children under CPS's care. This requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program, the ESPER cohort (Prospective cohort study of protected children), which will enable us to carry out a comparative evaluation of the PEGASE program, as well as to provide information on the health of children followed by the CPS at the time of their placement and its evolution over time, data which are rare in France.

The main objective is to evaluate the effectiveness of the PEGASE program on the evolution of the mental health of children followed by the CPS after 2 years of follow-up.

Eligibility

Sex
ALL
Min age
0 Months
Max age
42 Months
Healthy volunteers
No
Inclusion Criteria: * Child under the supervision of child protective services, * Arriving for the first time in a participating center, * Less than 42 months old (i.e. 3 and a half years), * Non-opposition of the holders of parental authority (in the event of impossibility to obtain the non-opposition of both holders of parental authority, the non-opposition of one of them will be obtained). Exclusion Criteria: • Children whose child protection measure has not been confirmed by a judicial or administrative decision.

Primary outcome measure(s)

  • Mental health — two years of follow-up
    The primary endpoint is the ASQ-SE questionnaire score after two years of follow-up, dichotomized into: 1/ Failure: the child is above the alert threshold defined for his/her age, indicating the need to initiate or maintain adapted care; 2/ Success: the child is below the age-defined alert threshold (i.e. "within the norm" for his or her age). The ASQ-SE assesses socio-emotional development, a reflection of mental health in young children. The higher the score, the more worrying the child's condition. As socio-emotional development evolves with age, nine questionnaires are available, depending on the child's age: 2, 6, 12, 18, 24, 30, 36, 48 and 60 months. The questionnaire is made up of around 36 items (the number of items varies according to the age of the child) and is associated with a score (the total score is a function of the number of items, and therefore differs according to age) and alert thresholds.

Trial sites (7)

FacilityCityRegionStatus
Maternal and Child Protection - The Eure Department Évreux France Recruiting
Departmental institution to support - accompany - educate Lille France Recruiting
Moselle Departmental Children's Centre Metz France Recruiting
Maternal and Child Protection Rouen France Recruiting
Maternal and Child Protection Saint-Brieuc France Recruiting
Children and Family Home of the Loire Saint-Genest-Lerpt France Recruiting
Departmental Observatory for Child Protection Toulon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06805682 on ClinicalTrials.gov ↗ ← All trials in France