NCT06805682 Prospective Cohort Study of Protected Children
| NCT ID | NCT06805682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Mental Health Conditions |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2029-02-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2025-02-18 with a primary completion date of 2029-02-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Morgane MICHEL, MD
PRINCIPAL INVESTIGATOR
Clinical Epidemiology Unit, Robert Debré Hospital (Assistance Publique - Hôpitaux de Paris)
Frequently Asked Questions
Who can join the NCT06805682 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 42 Months, studying Mental Health Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06805682 currently recruiting?
Yes, NCT06805682 is actively recruiting participants. Contact the research team at morgane.michel@aphp.fr for enrollment information.
Where is the NCT06805682 trial being conducted?
This trial is being conducted at Évreux, France, Lille, France, Metz, France, Rouen, France and 3 additional locations.
Who is sponsoring the NCT06805682 clinical trial?
NCT06805682 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Morgane MICHEL, MD at Clinical Epidemiology Unit, Robert Debré Hospital (Assistance Publique - Hôpitaux de Paris). The trial plans to enroll 220 participants.