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Investigating Phenotypic Profiles of Children and Adolescents With ASD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02700113
Acronym
Phenotyping
Enrollment
72
Registered
2016-03-07
Start date
2014-11-30
Completion date
2019-08-30
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorders

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.

Interventions

OTHERNo intervention

Intervention is not a part of this study. This is a behavioral phenotyping study of minimally verbal individuals with Autism Spectrum Disorder.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Northeastern University
CollaboratorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
Boston University Charles River Campus
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Autism Spectrum Diagnosis5 yearsInterview
Adaptive Abilities5 yearsInterview
Cognitive Abilities5 yearsInterview
Language5 yearsInterview
Social Behavior5 yearsInterview
Repetitive Behavior5 yearsQuestionnaire
Sensory Behaviors5 yearsQuestionnaire
Atypical Behavior5 yearsQuestionnaire
Psychopathology5 yearsQuestionnaire
Emotion Regulation5 yearsQuestionnaire
Handedness5 yearsQuestionnaire
Electrophysiological Measures and Neural Oscillatory Patterns of Perception, Organization, and Analysis of Auditory scenes5 yearsPhysiological parameter
Indices of social attention deployment measured by unobtrusively recording participants' eye-movements during the passive viewing of brief realistic video-clips.5 yearsPhysiological 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).5 yearsPhysiological parameter

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026