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Clinical Trials/NCT02700113
NCT02700113
Completed
Not Applicable

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 site in 1 country72 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorders
Sponsor
Boston University Charles River Campus
Enrollment
72
Locations
1
Primary Endpoint
Autism Spectrum Diagnosis
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
August 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Boston University Charles River Campus
Responsible Party
Principal Investigator
Principal Investigator

Helen B. Tager-Flusberg

Professor

Boston University

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Autism Spectrum Diagnosis

Time Frame: 5 years

Interview

Cognitive Abilities

Time Frame: 5 years

Interview

Sensory Behaviors

Time Frame: 5 years

Questionnaire

Atypical Behavior

Time Frame: 5 years

Questionnaire

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

Time Frame: 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).

Time Frame: 5 years

Physiological parameter

Language

Time Frame: 5 years

Interview

Social Behavior

Time Frame: 5 years

Interview

Repetitive Behavior

Time Frame: 5 years

Questionnaire

Emotion Regulation

Time Frame: 5 years

Questionnaire

Adaptive Abilities

Time Frame: 5 years

Interview

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

Time Frame: 5 years

Physiological parameter

Psychopathology

Time Frame: 5 years

Questionnaire

Handedness

Time Frame: 5 years

Questionnaire

Study Sites (1)

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