Prospective Cohort Study of Protected Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-42
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Usual Care
Other interventionChildren will be followed using each CPS participating center's usual practices
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: ESPER1 intervention
Trial outcomes
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.
Time frame
two years of follow-upSecondary outcomes
1
Mental health_ASQ-SE questionnaire
* Standardized ASQ-SE score: in order to compensate for the variability of the total score scales according to age, the score obtained at the different ages will be standardized between 0 and 100 * ASQ-SE questionnaire score dichotomized into success or failure
Time frame
1 and 2 years of follow-up2
Body mass index
Body mass index will be expressed in z-score, as a function of age and sex
Time frame
1 and 2 years of follow-up3
Growth restriction
Percentage of children whose height is below the fifth percentile for their age and sex on a standard growth curve
Time frame
1 and 2 years of follow-up4
Communication skills
Assessed with the ASQ-3 "Communication" subscale score. The ASQ-3 screens for developmental delays on five subscales. The lower the score, the more worrying the child's condition. Like the ASQ-SE, the ASQ-3 questions evolve with the child's age, with a maximum score that varies with age, and alert thresholds available for each questionnaire (at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 42, 48, 54 and 60 months). o The score will be dichotomized into failure (score below the alert threshold defined for their age for initiating or maintaining appropriate management) or success (score above the alert threshold), and standardized between 0 and 100 (similarly to the ASQ-SE)
Time frame
1 and 2 years of follow-upOther outcomes
1
ASQ-3
The percentage of children with ASQ-3 questionnaire score dichotomized into success or failure will be compared between ESPER and other existing French children cohorts after matching the cohorts
Time frame
at inclusion, 1 year and 2 years of follow-up2
BMI
The BMI expressed in z-score, as a function of age and sex will be compared between ESPER and other existing French children cohorts after matching the cohorts
Time frame
at inclusion, 1 year and 2 years of follow-up3
Growth restriction
The percentage of children whose height is below the fifth percentile for their age and sex on a standard growth curve will be compared between ESPER and other existing French children cohorts after matching the cohorts
Time frame
at inclusion, 1 year and 2 years of follow-up4
Care pathway
The percentage of children with complete vaccination protocols will be compared between ESPER and other existing French children cohorts after matching the cohorts
Time frame
at inclusion, 1 year and 2 years of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Saint-Exupéry Association
Collaborator
Source ClinicalTrials.gov