- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05707923
How Simplified Language Affects Comprehension and Learning in Young Autistic Children (PALS)
April 16, 2025 updated by: Courtney E. Venker, Michigan State University
How Single-Word and Telegraphic Simplification Affects Language Processing and Word Learning in Young Children With Autism Spectrum Disorder
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Courtney Venker, PhD
- Phone Number: 5178842259
- Email: cvenker@msu.edu
Study Locations
-
-
Michigan
-
East Lansing, Michigan, United States, 48824
- Recruiting
- Michigan State University
-
Contact:
- Courtney Venker, PhD
- Phone Number: 5178842259
- Email: cvenker@msu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Utterance Type
This study uses a within-participant experimental manipulation.
All participants will be exposed to all utterance types (across trials).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gaze location on Looking-While-Listening (LWL) tasks
Time Frame: Single assessment per task; total duration less than 10 minutes per task
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gaze location in Teaching Phase of Study 2b (Fast Mapping)
Time Frame: Single assessment; total duration less than 10 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
January 3, 2023
First Submitted That Met QC Criteria
January 31, 2023
First Posted (Actual)
February 1, 2023
Study Record Updates
Last Update Posted (Actual)
April 20, 2025
Last Update Submitted That Met QC Criteria
April 16, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4584124
- R01DC020165 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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