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Completed

NCT Number: NCT02700113

Investigating Phenotypic Profiles of Children and Adolescents With ASD

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.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston University

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Autism Spectrum Diagnosis

    Time frame: 5 years

    Interview

  2. Adaptive Abilities

    Time frame: 5 years

    Interview

  3. Cognitive Abilities

    Time frame: 5 years

    Interview

  4. Language

    Time frame: 5 years

    Interview

  5. Social Behavior

    Time frame: 5 years

    Interview

  6. Repetitive Behavior

    Time frame: 5 years

    Questionnaire

  7. Sensory Behaviors

    Time frame: 5 years

    Questionnaire

  8. Atypical Behavior

    Time frame: 5 years

    Questionnaire

  9. Psychopathology

    Time frame: 5 years

    Questionnaire

  10. Emotion Regulation

    Time frame: 5 years

    Questionnaire

  11. Handedness

    Time frame: 5 years

    Questionnaire

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

    Time frame: 5 years

    Physiological parameter

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)
  • Northeastern University

Registry information

Official study title

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

Acronym: Phenotyping

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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