Observational study on the health of children in protective services
PEGASE3, Experimental Program of a Standardized Health Protocol Applied to Children Who Benefited From a Child Protection Measure Before the Age of Five: Effectiveness and Efficiency
This study looks at the health and development of children recently placed in protective services in France to see how a special health program helps them compared to those who don’t receive it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 0 Months to 42 Months |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 7 sites (Évreux, France and 6 other locations) |
| Trial ID | NCT06805682 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the health status and developmental needs of children under the care of child protective services in France. It focuses on children who are newly placed in care and assesses their mental and physical health through standardized check-ups. The PEGASE program, funded by the French government, seeks to ensure adequate medical follow-up for these children, addressing both somatic and psychiatric needs. A control cohort will be created to compare outcomes between children receiving the PEGASE program and those who do not.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 42 months old who are newly placed under the supervision of child protective services.
Not a fit: Children whose protective measures have not been confirmed by judicial or administrative decisions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes and better support for children in protective services.
How similar studies have performed: While there is limited data on similar studies, the approach of comprehensive health monitoring for vulnerable children is promising and has shown potential in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Évreux, France and 6 other locations
- Maternal and Child Protection - The Eure Department — Évreux, France, France (Recruiting)
- Departmental institution to support - accompany - educate — Lille, France, France (Recruiting)
- Moselle Departmental Children's Centre — Metz, France, France (Recruiting)
- Maternal and Child Protection — Rouen, France, France (Recruiting)
- Maternal and Child Protection — Saint-Brieuc, France, France (Recruiting)
- Children and Family Home of the Loire — Saint-Genest-Lerpt, France, France (Recruiting)
- Departmental Observatory for Child Protection — Toulon, France, France (Recruiting)
Study contacts
- Principal investigator: Morgane MICHEL, MD — Clinical Epidemiology Unit, Robert Debré Hospital (Assistance Publique - Hôpitaux de Paris)
- Study coordinator: Morgane MICHEL, MD
- Email: morgane.michel@aphp.fr
- Phone: +33 1 57 27 89 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.