NCT02700074

Brief Summary

The main goal of our study is to find out why some people with Autism Spectrum Disorder (ASD) do not develop verbal abilities or remain minimally-verbal throughout adolescence and adulthood. Current research focuses on investigating brain differences related to processing sounds and initiating speech in adolescents and young adults with ASD varying in language skills, compared to adolescents who do not have ASD, in order to clarify whether atypical processes of auditory perception, perceptual organization and/or neural oscillation patterns may explain why some individuals with ASD fail to acquire functional speech.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

February 24, 2016

Last Update Submit

January 22, 2020

Conditions

Outcome Measures

Primary Outcomes (15)

  • Autism Spectrum Diagnosis

    Interview

    5 years

  • Adaptive Behaviors

    Interview

    5 years

  • Cognitive Abilities

    Interview

    5 years

  • Language Abilities

    Interview and Questionnaire

    5 years

  • Social Behavior

    Interview

    5 years

  • Repetitive Behavior

    Questionnaire

    5 years

  • Sensory Behavior

    Questionnaire

    5 years

  • Atypical Behavior

    Questionnaire

    5 years

  • Psychopathology

    Questionnaire

    5 years

  • Emotion Regulation

    Questionnaire

    5 years

  • Handedness

    Questionnaire

    5 years

  • Brain measures of structural and functional connectivity in key nodes of the speech production network

    In particular between the supplementary motor area (SMA) and ventral premotor cortex (vPMC), a set of nodes in the speech network that is critical for the initiation of speech motor programs. High resolution MRI brain scans collected from adolescents with ASD who vary in their language ability from minimally verbal to normal (and a typical control group). Measures of structural anatomical connectivity based on Diffusion Tensor Imaging (DTI) data and functional connectivity based on resting state functional connectivity MRI.

    5 years

  • Electrophysiological measures and neural oscillatory patterns of the perception, organization and analysis of auditory scenes.

    Physiological parameter

    5 years

  • 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

  • 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

Study Arms (4)

Minimally Verbal

Minimally verbal adolescents with Autism Spectrum Disorder

Other: No Intervention

Verbal Impaired

Language impaired adolescents with ASD

Other: No Intervention

Verbal Normal

Language normal adolescents with ASD

Other: No Intervention

Typically Developing

Typically developing adolescent controls

Other: No Intervention

Interventions

Intervention is not a part of this study.

Minimally VerbalTypically DevelopingVerbal ImpairedVerbal Normal

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Between the ages of 14 and 21
  • Minimally verbal (which is defined as having fewer than 10 words/phrases used communicatively during the Autism Diagnostic Observation Schedule (ADOS) assessment
  • Demonstrated minimal progress in speech acquisition despite having participated in speech therapy for at least 18 months
  • Diagnosis of Autism Spectrum Disorder (ASD)
  • Verbal but language impaired (defined as more than 1.25 standard deviation below the mean on the clinical evaluation of language fundamentals - Fourth edition (CELF-4))
  • Has normal language scores (on the CELF-4)
  • Is typically developing with no history of psychiatric or neurological disorders

You may not qualify if:

  • Has contraindications to having a magnetic resonance imaging (MRI) scan (e.g. electronic/ferromagnetic implant, clips, stents, existing or planned major dental work)
  • Has a history of significant neurological diseases
  • Has a history of sensory impairment (e.g., hearing impairment)
  • Has a history of disorders other than ASD
  • Is currently taking antipsychotic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related 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.

    PMID: 24124067BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Helen Tager-Flusberg, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 7, 2016

Study Start

February 1, 2015

Primary Completion

May 31, 2019

Study Completion

August 30, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations