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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 7
- 主要终点
- Mental health
研究概览
简要总结
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.
详细描述
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, making child abuse a real challenge for society, both on an individual level, in terms of equal opportunities, and on a collective level, from a public health and economic point of view. In France, 308,000 minors benefit from at least one child protection service or measure. There are few data available on the health status of this population and its evolution over time, but they all point to the poor health status of children when first placed into care, with a particularly high prevalence of mental disorders, a low proportion of children benefiting from an initial health check-up, and poor quality of medical follow-up once in care.
In this context, interventions are needed to address early and comprehensively the many needs of children put into care, both in the short and long term. In particular, early detection and reduced delays in the initiation of appropriate medical care appear to have positive long-term effects, reducing medico-social needs. As such, the PEGASE program, which is funded by the French government under Article 51, was developed to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS).
Children in the PEGASE program are monitored with regular, standardized check-ups, with an initial standardized check-up when the child enters the care facility followed by 20 regular assessments at fixed ages up to the age of 7. Most of these assessments are reinforced in PEGASE by the systematic use of standardized scales to identify potential disorders and developmental delays, so that the necessary care can be implemented at an early stage.
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 in care. As there is no control group in the PEGASE program, this requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program. This is 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 taken into care by the CPS at the time of their placement, and on its evolution over time, data which are rare in France.
The primary 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Children whose child protection measure has not been confirmed by a judicial or administrative decision.
研究组 & 干预措施
ESPER
Children under the care of child protective services and followed using usual practices
干预措施: Usual Care (Other)
结局指标
主要结局
Mental health
时间窗: two years of follow-up
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.
次要结局
- 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)
- Fine motor development(1 and 2 years of follow-up)
- Care pathway(1 and 2 years of follow-up)
- School integration(1 and 2 years of follow-up)
- Cost-effectiveness(2 years of follow-up)
- Developmental gains associated with the generalization of the program(extrapolation at 5 years after hypothetical generalization)
- Children's health at admission(measured at study inclusion)
- Costs associated with the generalization of the program(extrapolation at 5 years after hypothetical generalization)