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Investigating Phenotypic Profiles of Children and Adolescents With ASD (Phenotyping)

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ClinicalTrials.gov Identifier: NCT02700113
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : January 19, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Northeastern University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Helen B. Tager-Flusberg, Boston University

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.

Condition or disease Intervention/treatment
Autism Spectrum Disorders Other: No intervention

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.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Investigating Phenotypic Profiles of Minimally Verbal Children and Adolescents With ASD/Profiles of Abilities in Children and Adolescents With ASD
Study Start Date : November 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ASD
There is only one group; minimally verbal individuals with Autism Spectrum Disorder aged 4 to 17 years.
Other: No intervention
Intervention is not a part of this study. This is a behavioral phenotyping study of minimally verbal individuals with Autism Spectrum Disorder.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700113


Contacts
Contact: Helen Tager-Flusberg, PhD 1-617-358-5910 htagerf@bu.edu
Contact: Brittany Dorer, M.Ed 1-617-358-5912 bdorer@bu.edu

Locations
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Helen Tager-Flusberg, PhD    617-358-5910    htagerf@bu.edu   
Contact: Brittany Dorer, M.Ed    6173585912    bdorer@bu.edu   
Principal Investigator: Helen Tager-Flusberg, PhD         
Sub-Investigator: Daniela Plesa-Skwerer, PhD         
Sponsors and Collaborators
Boston University Charles River Campus
National Institutes of Health (NIH)
Northeastern University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Helen Tager-Flusberg, PhD Boston University

Additional Information:
Publications:
Responsible Party: Helen B. Tager-Flusberg, Professor, Boston University
ClinicalTrials.gov Identifier: NCT02700113     History of Changes
Other Study ID Numbers: 3646E
P50DC013027 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders