Prospective Cohort Study of Protected Children

NCT06805682 | Recruiting

• 3 other identifiers: APHP230596PREPS-22-00582024-A00953-44
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 7

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.

Conditions

Mental Health Conditions; Physical Health Status; Child Development

Keywords

Child Protective Services; Child Development; Mental health; Cohort study; Comparative study

Outcome Measures

Primary Outcomes (1)

• Mental health

  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.

  two years of follow-up

Secondary Outcomes (12)

• Mental health_ASQ-SE questionnaire

  1 and 2 years of follow-up

• Body mass index

  1 and 2 years of follow-up

• Growth restriction

  1 and 2 years of follow-up

• Communication skills

  1 and 2 years of follow-up

• Gross motor development

  1 and 2 years of follow-up

Other Outcomes (5)

• ASQ-3

  at inclusion, 1 year and 2 years of follow-up

• BMI

  at inclusion, 1 year and 2 years of follow-up

• Growth restriction

  at inclusion, 1 year and 2 years of follow-up

Study Arms (1)

ESPER

Children under the care of child protective services and followed using usual practices

Other: Usual Care

Interventions

Usual Care OTHER

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

ESPER

Eligibility Criteria

• Age: 0 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children from the control cohort will be included in the participating services of 7 French departments (the territorial level responsible for CPS in France) not participating in the PEGASE program. The child protection measure can be exercised either in an institution, a foster family or an open environment service.

You may qualify if:

• 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).

You may not qualify if:

• Children whose child protection measure has not been confirmed by a judicial or administrative decision.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Saint-Exupéry Association: collaborator

Study Sites (7)

Maternal and Child Protection - The Eure Department

Évreux, France, 27000, France

RECRUITING

Departmental institution to support - accompany - educate

Lille, France, 59000, France

RECRUITING

Moselle Departmental Children's Centre

Metz, France, 57050, France

RECRUITING

Maternal and Child Protection

Rouen, France, 76100, France

RECRUITING

Maternal and Child Protection

Saint-Brieuc, France, 22000, France

RECRUITING

Children and Family Home of the Loire

Saint-Genest-Lerpt, France, 42530, France

RECRUITING

Departmental Observatory for Child Protection

Toulon, France, 83000, France

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Morgane MICHEL, MD

  Clinical Epidemiology Unit, Robert Debré Hospital (Assistance Publique - Hôpitaux de Paris)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgane MICHEL, MD

CONTACT

+33 1 57 27 89 68; morgane.michel@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 3, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): February 17, 2029
• Study Completion (Estimated): February 17, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)