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How Simplified Language Affects Comprehension and Learning in Young Autistic Children (PALS)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Linguistic simplification
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring language, autism, intervention, processing, learning, early childhood, treatment, early intervention, telegraphic, language input, looking-while-listening, eye tracking, comprehension, neurodevelopmental disorders

Eligibility Criteria

1 Year - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michigan State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Utterance Type

Arm Description

This study uses a within-participant experimental manipulation. All participants will be exposed to all utterance types (across trials).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 3, 2023
Last Updated
May 8, 2023
Sponsor
Michigan State University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT05707923
Brief Title
How Simplified Language Affects Comprehension and Learning in Young Autistic Children
Acronym
PALS
Official Title
How Single-Word and Telegraphic Simplification Affects Language Processing and Word Learning in Young Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
language, autism, intervention, processing, learning, early childhood, treatment, early intervention, telegraphic, language input, looking-while-listening, eye tracking, comprehension, neurodevelopmental disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Utterance Type
Arm Type
Experimental
Arm Description
This study uses a within-participant experimental manipulation. All participants will be exposed to all utterance types (across trials).
Intervention Type
Behavioral
Intervention Name(s)
Linguistic simplification
Intervention Description
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).
Primary Outcome Measure Information:
Title
Gaze location on Looking-While-Listening (LWL) tasks
Description
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.
Time Frame
Single assessment per task; total duration less than 10 minutes per task
Secondary Outcome Measure Information:
Title
Gaze location in Teaching Phase of Study 2b (Fast Mapping)
Description
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).
Time Frame
Single assessment; total duration less than 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Venker, PhD
Phone
5178842259
Email
cvenker@msu.edu
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Venker, PhD
Phone
517-884-2259
Email
cvenker@msu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Dataset will include eye-gaze data, assessment scores, and transcriptions. De-identified analyzed data will be shared with other scientists for non-commercial research purposes in accordance with Michigan State University policy. Pending informed consent, de-identified data will be uploaded to the National Database for Autism Research, and transcripts will be shared with ASDBank. Scientific resources generated will be made available prior to publication if the work is different from our purposes. Following publication, resources will be made available to the broader scientific community on request. Findings and de-identified data will be shared through a variety of avenues, including scientific and clinical conferences, webinars, newsletters and scholarly manuscripts. Identifiable data may be shared if a family provides consent. All peer-reviewed manuscripts will be submitted to NIH's PubMed Central, to be made available at least 12 months after the official publication date.

Learn more about this trial

How Simplified Language Affects Comprehension and Learning in Young Autistic Children

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