Long-term Efficacy of Early Intervention With Early Start Denver Model (ESDM) on the Severity of Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- ADOS (Autism Diagnostic Observation Schedule )
研究概览
简要总结
The aim of this study is to assess the efficiency of early treatment for ASD children 5 years after initial treatment.
The early treatment implemented was 12 hours per week of ESDM versus treatment as usual during 2 years. This was done as an RCT, called IDEA. Children will now be included in IDEA-2 SCOLA, a three year follow up study.
详细描述
180 children with ASD, younger than 3 years old, were included in the IDEA RCT. Children were allocated to the ESDM treatment group or the treatment as usual group. The aim of IDEA-2 is to follow-up this population for 3 years after the initial 2 years of intervention, that is, 5 years after initial inclusion to IDEA.
Investigators hypothesize that children who received ESDM 12 hours per week will have a significant decrease of autism symptoms and will have a better scholastic level 5 years after initial inclusion to IDEA.
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)
盲法说明
randomization will follow that of the IDEA study
入排标准
- 年龄范围
- 39 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion in the initial IDEA trail
- •Requiring less than 40 minutes travel to the assessment center
排除标准
- •Impossibility of coming in for assessment
- •Exclusion from IDEA
结局指标
主要结局
ADOS (Autism Diagnostic Observation Schedule )
时间窗: 3 YEARS
Autism Diagnostic Observation Schedule is a semi-structured, standardized, observational tool, which measures core autism symptoms, that is to say reciprocal sociocommunicative interaction, and repetitive and restrictive behaviors. This assessment will be administered by an assessor blind to the allocation group.
次要结局
- VABS (Vineland Adaptive Behavior Scales)(3 YEARS)
- Parental self-assentiment(3 YEARS)
- Wechsler (Wechsler Intelligence Scale for Children)(3 YEARS)
- PPVT ( Peabody Picture Vocabulary Test )(3 YEARS)