NCT06951516

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 Down syndrome (DS). The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with DS (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 DS will process grammatical utterances faster and more accurately than telegraphic or single-word utterances. Aim 2 will test the hypothesis that overall, children will demonstrate better word learning in the grammatical compared to the single-word and telegraphic conditions. Aim 3 will test the hypothesis that receptive language and nonverbal cognitive abilities will be significant moderators, such that children with stronger linguistic and cognitive skills will show the greatest benefit from grammatical input but children with lower linguistic and cognitive scores will perform similarly across conditions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jan 2025May 2027

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

April 16, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

Down syndromelanguage developmentlanguage processinglanguage input

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • Gaze location in Teaching Phase of Study 2b (Fast Mapping)

    Baseline

Study Arms (1)

Utterance Type

EXPERIMENTAL

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

Behavioral: Linguistic simplification

Interventions

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).

Utterance Type

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Down syndrome
  • English as primary language
  • years old

You may not qualify if:

  • Acquired brain injury
  • Cerebral palsy
  • Uncorrected vision or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Courtney Venker, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Venker, PhD

CONTACT

Jennifer Johnson, M.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2025

First Posted

April 30, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations