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临床试验/NCT03517163
NCT03517163已完成不适用

The Boston Outcomes of Autism in Toddlers Study

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
225
试验地点
1
主要终点
Cognitive Level

研究概览

简要总结

The purpose of this research study is to learn more about the outcomes of children who received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is interested in whether an early diagnosis can help children with their cognitive, language, social, and behavioral abilities.

详细描述

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in domains of social communication and restrictive and repetitive behavior. There is general agreement, in light of knowledge around optimal periods of neural plasticity, that ASD should be diagnosed as early as possible since young toddlers are at a critical stage in early development when intervention is theoretically most effective. The rate of persistence of an ASD diagnosis is heavily debated.Therefore this study attempts:

  1. To determine the rate of persistence of Autism Spectrum Disorder (ASD) diagnosis and functional outcomes, as defined by cognitive level, adaptive functioning, language skills, persistence of ASD symptoms, and classroom placement at kindergarten age, among children who received a DSM-5 ASD diagnosis at < 36 months.
  2. To evaluate predictors of rate of persistence and functional outcomes among kindergarten grade level children ages 5-7 years, who received an ASD diagnosis as toddlers.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Autism Spectrum Disorder as a toddler through DSM-5 at Boston Children's Hospital
  • Enrolled in or just finished Kindergarten

排除标准

  • Individuals with known genetic disorders including, but not limited to, Fragile X syndrome, Down syndrome, Tuberous Sclerosis Complex and those with 16 p deletions/duplications.

结局指标

主要结局

Cognitive Level

时间窗: 3 years (Age of diagnosis to Kindergarten Age)

Play-based assessment in which a child's cognitive level is determined. (Differential Ability Scales - Second Edition)

Adaptive Functioning

时间窗: 3 years (Age of diagnosis to Kindergarten Age)

Parent report on the child's current adaptive functioning (Vineland Adaptive Behavior Scales-3)

ASD Symptomatology

时间窗: 3 years (Age of diagnosis to Kindergarten Age)

The severity of ASD symptoms in the child (Autism Diagnostic Observation Schedule and Autism Diagnostic Interview-Revised)

Language Level

时间窗: 3 years (Age of diagnosis to Kindergarten Age)

Play-based assessment in which a child's language level is determined.Preschool Language Scale - Fifth Edition

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Harstad

Pediatrician

Boston Children's Hospital

研究点 (1)

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