NCT02700113

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

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

November 1, 2014

Completed
1.3 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

June 1, 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

4.6 years

First QC Date

February 24, 2016

Last Update Submit

January 22, 2020

Conditions

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (14)

  • Autism Spectrum Diagnosis

    Interview

    5 years

  • Adaptive Abilities

    Interview

    5 years

  • Cognitive Abilities

    Interview

    5 years

  • Language

    Interview

    5 years

  • Social Behavior

    Interview

    5 years

  • Repetitive Behavior

    Questionnaire

    5 years

  • Sensory Behaviors

    Questionnaire

    5 years

  • Atypical Behavior

    Questionnaire

    5 years

  • Psychopathology

    Questionnaire

    5 years

  • Emotion Regulation

    Questionnaire

    5 years

  • Handedness

    Questionnaire

    5 years

  • Electrophysiological Measures and Neural Oscillatory Patterns of 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 (1)

ASD

There is only one group; minimally verbal individuals with Autism Spectrum Disorder aged 4 to 17 years.

Other: No intervention

Interventions

No interventionOTHER

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

ASD

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

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 ONLY
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

November 1, 2014

Primary Completion

June 1, 2019

Study Completion

August 30, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)