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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05707923
Other study ID # 4584124
Secondary ID R01DC020165
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date May 31, 2027

Study information

Verified date November 2023
Source Michigan State University
Contact Courtney Venker, PhD
Phone 5178842259
Email cvenker@msu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with ASD. The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with ASD (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with ASD will process full, grammatical utterances faster and more accurately than single-word or telegraphic utterances. Aim 2 will test the hypothesis that full, grammatical utterances will support word learning better than telegraphic or single-word utterances. Aim 3 will test the hypothesis that language and cognitive skills significantly moderate the effects of linguistic simplification on language processing and word learning in young children with ASD.


Recruitment information / eligibility

Status Recruiting
Enrollment 104
Est. completion date May 31, 2027
Est. primary completion date May 31, 2027
Accepts healthy volunteers No
Gender All
Age group 1 Year to 4 Years
Eligibility Inclusion Criteria: - Existing or suspected autism spectrum disorder, confirmed through ADOS-2 - English as primary language - 1-4 years old Exclusion Criteria: - Known genetic condition (e.g., Down syndrome, fragile X) - Cerebral palsy - Acquired brain injury - Uncorrected vision or hearing impairment

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Linguistic simplification
Children will participate in screen-based language processing and word learning tasks in which they hear utterances with different types and amounts of linguistic simplification (i.e., a within-group manipulation).

Locations

Country Name City State
United States Michigan State University East Lansing Michigan

Sponsors (2)

Lead Sponsor Collaborator
Michigan State University National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gaze location on Looking-While-Listening (LWL) tasks LWL involves a child looking at a screen with two images, one on each side of the screen, while being provided an auditory cue that includes the name of the target image. The primary outcome is a dichotomous variable indicating whether the child is fixated on the target image or the distracter image; gaze directed at neither image will be considered missing. It will be determined whether gaze is to the left or right image, using trained coders who are blind to target side. Gaze location will be observed every 33 ms from 300 ms after onset to 2000 ms after target word onset, for a total of 51 observations per trial. Analyses will focus on differences across trial types and child characteristics in the trajectory of gaze location over the course of the trial. Single assessment per task; total duration less than 10 minutes per task
Secondary Gaze location in Teaching Phase of Study 2b (Fast Mapping) A secondary outcome measure will be gaze location during the Teaching Phase of the Fast Mapping task (Study 2b). The variable is a dichotomous variable indicating whether the child is fixated on the novel image (only a single image is presented in each trial during the Teaching Phase) or not. It will be determined whether gaze is directed to the novel image, as our prior attempts to manually code single-object trials have not been successful. Only children who successfully calibrate and provide adequate automatic eye-tracking data in the Fast Mapping task will be included. Gaze location will be observed every 33 ms during the Teaching Trials. Analyses will focus on differences across trial types (single-word vs. full, grammatical teaching utterances). Single assessment; total duration less than 10 minutes
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