Actively Recruiting

Age: 0Months - 42Months
All Genders
ID06805682

PEGASE3: Evaluating a Standardized Health Program for Children Under Five in Child Protective Care

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-13

220

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

S

Saint-Exupéry Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to study the health and development of children who are taken into care by child protective services (CPS) and to evaluate the PEGASE program designed to provide regular, standardized medical follow-ups, including mental and physical health assessments. The study focuses on children under CPS care who are not enrolled in the PEGASE program, creating a control group called the ESPER cohort. The goal is to compare health outcomes and program effectiveness over time, with a special focus on mental health after two years. Children in the ESPER cohort are followed using the usual care practices of their CPS centers without the additional PEGASE standardized assessments. The study collects data at the time of placement and then at one and two years later through questionnaires and health records, including developmental assessments using standardized tools like ASQ-SE and ASQ-3. The program includes children less than 42 months old at their first entry into the center and involves a follow-up period of two years. Participating children will have health and developmental data collected at baseline, one year, and two years, either in person or by phone if no longer in care. Information includes mental health, physical growth, communication and motor skills, school integration, and care pathways. The primary outcome is mental health after two years, with secondary outcomes covering various developmental and health measures and a cost-effectiveness evaluation. The study plans to enroll 220 children over 24 months, with each child followed for 24 months.

CONDITIONS

Brief Title

Prospective Cohort Study of Protected Children

Who Can Participate

Age: 0Months - 42Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child under the supervision of child protective services
  • First time arrival in a participating child protective center
  • Child is less than 42 months old (under 3 and a half years)
  • Non-opposition from holders of parental authority for participation
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and initial data collection

Monitoring

Duration - 24 months

Participants who are under the supervision of child protective services are observed while receiving usual care in participating centers. Health, developmental, and school integration data are collected to assess their evolution over time.

3 visits (in-person or by telephone) at inclusion, 1 year, and 2 years for questionnaires and data collection

Trial Site Locations

Total: 7 locations

1

Maternal and Child Protection - The Eure Department

Évreux, France, France, 27000

Actively Recruiting

2

Departmental institution to support - accompany - educate

Lille, France, France, 59000

Actively Recruiting

3

Moselle Departmental Children's Centre

Metz, France, France, 57050

Actively Recruiting

4

Maternal and Child Protection

Rouen, France, France, 76100

Actively Recruiting

5

Maternal and Child Protection

Saint-Brieuc, France, France, 22000

Actively Recruiting

6

Children and Family Home of the Loire

Saint-Genest-Lerpt, France, France, 42530

Actively Recruiting

7

Departmental Observatory for Child Protection

Toulon, France, France, 83000

Actively Recruiting

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Research Team

M

Morgane MICHEL, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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