Impact of Early Intervention on the Global Development of Children With Autism Spectrum Disorder in a European French-speaking Population Dr Marie-Maude GEOFFRAY Le Vinatier Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Developmental quotient at the Mullen Scale of Early Learning
研究概览
简要总结
Intervention for autism spectrum disorder (ASD) in European French-speaking countries is often heterogeneous and poorly evaluated. Six French-speaking early intervention units for children with ASD following the Early Start Denver Model (ESDM) have been created since 2011 with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the European French-speaking public health system. In those units, Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery.
The first aim of the investigators study is to evaluate the effectiveness of ESDM intervention 12 hours per week during 2 years on the global development of children with ASD compared to the interventions commonly available in the community.
详细描述
This is a multicenter (4 centers in France, 1 center in Switzerland and 1 center in Belgium), randomized, controlled, single blind trial using a modified Zelen design .It concerns children with ASD aged 18 to 36 months without severe neurological or physical disorder and living in the proximity of one the early intervention units. After diagnostic, Children will be included in a longitudinal cohort with the consent of the parents. Sixty children will be drawn lots among 180 children of the cohort and will be included in a ESDM intervention with the consent of the parents. Two groups will be compared: an experimental group of 60 children receiving 12 hours a week of ESDM intervention delivered by trained therapists during 2 years and a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. Global developmental profiles of all the children will be measured at different time points over the two years through standardized tests such as the Mullen Scale of Early Learning (MSEL), the ADOS-2 and the Vineland Adaptive Behavior Scale. Cost of each intervention will be calculated.
The primary outcome is global development of the child, measured by the developmental quotient with the Mullen after 24 months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 15 months to 36 months
- •Children with autism spectrum disorder (according to international criteria and standardized tests)
- •Children at a DQ of 30 at least at the MSEL
- •Family domiciled within 40 minutes of a early intervention unit (investigator center for the study)
排除标准
- •Severe neurological or physical disorder identified not allowing intensive care
- •Unavailability of the family for regular monitoring of the child by the investigator center
- •Rett Syndrom
结局指标
主要结局
Developmental quotient at the Mullen Scale of Early Learning
时间窗: Change from baseline in developmental quotient at 24 months follow-up
This criterion will be assessed with the Mullen scale of Early Learning (Mullen, 1995) by a psychologist blind of intervention group of the child:
次要结局
- Change at the Brief Observation of Social Communication Change (BOSCC)(At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up)
- Severity of autism symptoms is measured with ADOS 2(Change from baseline in severity score of autism symptoms at 24 months follow-up)
- Sensorial profil(At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2))
- Productive language level assessed with a standardized French productive language developmental scale(change from baseline in number of words at 24 months follow-up (T2))
- Costs associated with interventions(at 24 months follow-up (T2))
- Developement of communication and symbolic behavior(At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up)
- Adaptive behavior score is measured by the composite score of Vineland adaptative behavior scale 2(Change from baseline in adaptative behavior at 24 months follow-up)
- Parent child naturalistic interaction during play(At baseline (inclusion ° T0), at 12 months follow-up (T1), and at 24 months follow-up (T2))