Autism Spectrum DisorderPALSNCT05707923
How Simplified Language Affects Comprehension and Learning in Young Autistic Children
A study testing Linguistic simplification in people with Autism Spectrum Disorder, run by Michigan State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Linguistic simplification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Existing or suspected autism spectrum disorder, confirmed through ADOS-2
- English as primary language
- 1-4 years old
Who cannot join
- Known genetic condition (e.g., Down syndrome, fragile X)
- Cerebral palsy
- Acquired brain injury
- Uncorrected vision or hearing impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan State University
East Lansing, Michigan, 48824
Courtney Venker, PhD, 5178842259, cvenker@msu.edu
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Linguistic simplification
- Keywords
- language, autism, intervention, processing, learning, early childhood, treatment, early intervention, telegraphic, language input, looking-while-listening, eye tracking, comprehension, neurodevelopmental disorders
- Medical subject headings
- Autism Spectrum Disorder, Language, Autistic Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linguistic simplificationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Utterance Type | Experimental | This study uses a within-participant experimental manipulation. All participants will be exposed to all utterance types (across trials). Receives: Behavioral: Linguistic simplification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single assessment per task; total duration less than 10 minutes per task
Secondary outcomes (1)
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).
Measured: Single assessment; total duration less than 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jun 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Courtney E. Venker, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707923
- Sponsor's protocol ID
- 4584124
- Other IDs
- R01DC020165
- Acronym
- PALS
- Status last verified
- Jun 2026
- First submitted
- 3 Jan 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.