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临床试验/NCT02700113
NCT02700113已完成不适用

Investigating Phenotypic Profiles of Minimally Verbal Children and Adolescents With ASD/Profiles of Abilities in Children and Adolescents With ASD

Boston University Charles River Campus1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Autism Spectrum Diagnosis

研究概览

简要总结

The purpose of this study is to provide a detailed description of language and cognitive profiles found among children and adolescents diagnosed with autism spectrum disorders (ASD). Participants with ASD ages 4-17;12 years who have limited verbal skills will be given comprehensive behavioral assessments to collect data that will advance our understanding of language-related processes in individuals with ASD, the knowledge of which will help in designing future interventions for this population.

详细描述

About 25% to 30% of children with ASD fail to acquire spoken language. This group of children and adolescents with ASD has been neglected in research conducted over the past 2 decades, in part because the field lacks the tools to assess them, and they often pose significant behavioral challenges that preclude their participation in research studies. Among the ~70% individuals with ASD who have spoken language skills, about 50% are language impaired; the remaining group have normal language scores on standardized tests. To date, studies of brain and cognitive mechanisms that underlie this heterogeneity in ASD remain limited. The goal of this study, which is part of the Autism Center of Excellence, is to provide a detailed description of phenotypic profiles found among minimally verbal individuals diagnosed with ASD. Participants with ASD ages 4 to 18 will be given comprehensive assessments, including standardized assessments of language, nonverbal cognitive abilities and adaptive functioning. Assessments will also include experimental tasks based on using eye-tracking, touch screen and electrophysiology technology (EEG), parent-report measures and parent-child interaction measures. The eye-tracking and touch screen assessments will target receptive language, word learning mechanisms, and social attention deployment to visual and auditory stimuli. The EEG/ERP assessments will target auditory processing and organization, with specific focus on mismatch negativity (MMN) markers of auditory processing. Based on these comprehensive assessments the investigators aim to generate a description of the cognitive-behavioral phenotypes common to minimally verbal autistic individuals. The investigators will also investigate age-related patterns in the development of behavioral phenotypes and the role of symptom severity in shaping phenotypic profiles in this population. The investigators expect that their findings will provide valuable insights into the etiology of profound expressive language deficits in a significant proportion of the ASD population and will lead to identifying subphenotypes within the minimally verbal population.

研究设计

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

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will be included if they have a formal diagnosis of ASD, are 4-18 years old, and have a very small repertoire of spoken words or fixed phrases that are used communicatively, and that are restricted to limited contexts and functions (e.g. requests with familiar adults).

排除标准

  • have a history of significant neurological diseases, TBI, sensory impairment (e.g., significant visual or hearing impairment)
  • English is not the primary language spoken in the household.

结局指标

主要结局

Autism Spectrum Diagnosis

时间窗: 5 years

Interview

Cognitive Abilities

时间窗: 5 years

Interview

Sensory Behaviors

时间窗: 5 years

Questionnaire

Atypical Behavior

时间窗: 5 years

Questionnaire

Electrophysiological Measures and Neural Oscillatory Patterns of Perception, Organization, and Analysis of Auditory scenes

时间窗: 5 years

Physiological parameter

Indices of electrodermal activity (EDA) measured wirelessly with the Q sensor (a small wearable device designed to work in real-world environments in an untethered, unobtrusive way).

时间窗: 5 years

Physiological parameter

Language

时间窗: 5 years

Interview

Social Behavior

时间窗: 5 years

Interview

Repetitive Behavior

时间窗: 5 years

Questionnaire

Emotion Regulation

时间窗: 5 years

Questionnaire

Adaptive Abilities

时间窗: 5 years

Interview

Indices of social attention deployment measured by unobtrusively recording participants' eye-movements during the passive viewing of brief realistic video-clips.

时间窗: 5 years

Physiological parameter

Psychopathology

时间窗: 5 years

Questionnaire

Handedness

时间窗: 5 years

Questionnaire

次要结局

未报告次要终点

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helen B. Tager-Flusberg

Professor

Boston University

研究点 (1)

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