Investigating Phenotypic Profiles of Children and Adolescents With ASD

Autism Spectrum Disorders Clinical Trial

— Phenotyping  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700113
• Other study ID #: 3646E
• Secondary ID: P50DC013027
• Status: Completed
• Start date: November 2014
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2020
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 30, 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), Northeastern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tager-Flusberg H, Kasari C. Minimally verbal school-aged children with autism spectrum disorder: the neglected end of the spectrum. Autism Res. 2013 Dec;6(6):468-78. doi: 10.1002/aur.1329. Epub 2013 Oct 7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autism Spectrum Diagnosis	Interview	5 years
Primary	Adaptive Abilities	Interview	5 years
Primary	Cognitive Abilities	Interview	5 years
Primary	Language	Interview	5 years
Primary	Social Behavior	Interview	5 years
Primary	Repetitive Behavior	Questionnaire	5 years
Primary	Sensory Behaviors	Questionnaire	5 years
Primary	Atypical Behavior	Questionnaire	5 years
Primary	Psychopathology	Questionnaire	5 years
Primary	Emotion Regulation	Questionnaire	5 years
Primary	Handedness	Questionnaire	5 years
Primary	Electrophysiological Measures and Neural Oscillatory Patterns of Perception, Organization, and Analysis of Auditory scenes	Physiological parameter	5 years
Primary	Indices of social attention deployment measured by unobtrusively recording participants' eye-movements during the passive viewing of brief realistic video-clips.	Physiological parameter	5 years
Primary	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).	Physiological parameter	5 years

External Links

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