Randomized Pragmatic, Cluster, Stepped-wedge Trial of Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services for Care Before 1 Year of Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,400
- 试验地点
- 1
- 主要终点
- Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one
研究概览
简要总结
This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome
详细描述
This prospective cohort study is performed at several Maternal and Child Protection Services in France. It aims to early detect infants under 12 months of age with a developmental gap compared to that expected for their age.
The first consultation will occur at the same time as the infant's usual medical follow-up at the Maternal and Child Protection Service (usually vaccination in the fourth month and developmental examination at nine months). Two strategies will be evaluated during this visit to assess the infant's neurodevelopmental characteristics. In the first one, a health professional will assess the infant's neurodevelopmental characteristics through routine practice evaluations, such as motor skills, vocalizations, babbling, and social interactions. In the second one, the PREAUT grid will be used for screening of screening for autism spectrum disorder.
Patients with abnormal results in these evaluations would be referred to a specialized center early for advice and treatment if necessary. We will consider an early referral as the referral of infants to an adapted consultation within the month following the first consultation. Also, these patients will be assessed using the State-Trait Anxiety Inventory-Form Y and T and the QUALIN score.
After 12 months of follow-up, data regarding the received treatments of patients who were addressed to a specialized center will be performed.
At 24 and 36 months of follow-up, all the included patients will be assessed with the Modified Checklist for Autism in Toddlers, Revised with Follow-up instrument (M-CHAT-R/F) ,and the IDE ( the French version of the Child Development Inventory). In case of an abnormal result of the M-CHAT-R/F, the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) will be administered. In case of an abnormal result of the IDE, the Brunet-Lézine scale will be administered.
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
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants between 4 and 9 months of age followed up in the participating Maternal and Child Protection Services for the fourth and ninth-month mandatory vaccinations
- •Availability of a personnel telephone for at least one parent
- •Information to the parents for data collection and the active follow-up of the child until 36 months and express consent to participate in the research
- •Affiliation to a social security system or benefiting from the Medical assistance of the state
- •Mastery of a minimum of French according to the principal investigator or the presence of a French-speaking relative
排除标准
- •Infant with a severe neurological pathology such as encephalopathy
- •Refusal to participate in the study
结局指标
主要结局
Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one
时间窗: At 2 years of age
次要结局
- Measurement of the parents' psychological state at the time of the child's referral to the Medical psychological center(At a Medical-psychological center and at 2 and 3 years of age)
- Effectiveness of two screening strategies on the occurrence severity of Autism Spectrum Disorders (ASD) and Neurodevelopmental Disorders (NDD)(At 2 and 3 years of age)
- Predictive performance of the PREAUT grid (at four months and nine months) compared to the usual diagnosis(At 2 and 3 years of age)
- Association between ASD-NDD diagnosis and neonatal or familial risk factors(At 2 and 3 years of age of child's referral to the Medical psychological center)
- Quality of life assessed by the QUALIN score(At inclusion in Maternal and Child Protection Services or at Medical-psychological center and at 2 and 3 years of age)
- Impact on the family life (IOFS) of a child diagnosed with risk of Autism Spectrum and Neurodevelopmental Disorders(At 2 and 3 years of age)
- Evaluation of the implementation of the new model of systematic screening of infants in Maternal and Child Protection Services and systematic referral to the Medical-psychological center(Through study completion, an average of 4 years)
- Evaluation of the implementation of infant care in the Medical-psychological center(Through study completion, an average of 4 years)
- Qualitative study of the incentives and obstacles of the screening and early referral strategy with the Maternal and Child Protection Service's workers(Through study completion, an average of 4 years)
- Qualitative study of the screening and early referral strategy with parents(Through study completion, an average of 4 years)
- Description of the practice of identification by the Maternal and Child Protection Services and referral to the Medical-psychological center(At the inclusion, at the end of inclusion and at the late visit)
- Description of the care pathway in the two groups(At 4 years of the child)