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RecruitingNCT06512168MALDUpdated May 16, 2025

Measuring Aided Language Development

An interventional study of AAC Generative Language Intervention in Down Syndrome, Cerebral Palsy and Apraxia of Speech, sponsored by University of Central Florida. Recruiting at 1 site in United States. Open to participants aged 42 Months to 60 Months. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by University of Central Florida · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
42 Months to 60 Months
Sex
All
01

Study summary

The focus of the current study is to systematically investigate the psychometric properties of a range of aided language measures, which are based on the Graphic Symbol Utterance and Sentence Development Framework (Binger \& Kent-Walsh).

Read the detailed description

Our central hypotheses are: (1) psychometrically sound measures can be established to capture growth within and across different dimensions of language acquisition, and (2) some elicitation contexts will be better than others at capturing aided language growth. Specific Aim 1 identifies valid measures to characterize aided language progress. Aim 1A uses existing data to document the psychometric properties of a range of aided language measures for preschoolers at the early stages of aided communication acquisition who have received 4 months of aided language intervention. Aim 1B analyzes language progression for high-performing aided communicators who will receive 24 months of intervention; this allows for investigation across all phases of early aided language acquisition. Specific Aim 2 identifies elicitation contexts that demonstrate the most productive aided language use. Achievement of the aims will result in measures that demonstrate strong reliability, differentiate growth for different populations, describe different dimensions of language growth, and are clinically feasible.

02

Conditions studied

  • Down Syndrome
  • Cerebral Palsy
  • Apraxia of Speech
  • Speech Sound Disorder
  • Speech Disorders in Children
  • Speech and Language Disorder

Keywords

  • Augmentative and Alternative Communication
  • Complex Communication Needs
  • Assistive Technology
  • AAC
03

In context

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

This study's planned enrollment of 60 is above the median of 37 across 286 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

University of Central Florida is the lead sponsor of 104 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical Identification of Down Syndrome or Cerebral Palsy + Significant Speech Impairment
  • Must Speak English as a Primary Language
  • Must Be Able to Express At Least 25 Words (using any communication mode)
  • Must Be Able to Accurately Select Picture Symbols on iPad Communication App with at Least 50% Accuracy
  • Vision and Hearing within Functional Limits or Corrected to be within Functional Limits for Study Activities

Exclusion criteria

Exclusion Criteria:

  • Clinical Diagnosis of Autism or Social Communication Disorder
  • Primary Language Spoken is A Language Other than English
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    AAC Generative Language Intervention

    Behavioral: AAC Generative Language Intervention

Interventions

  • BehavioralAAC Generative Language Intervention

    Aided AAC Language Input/Output Intervention

06

What researchers measure

Primary outcomes

  1. Aided AAC Utterance Length

    Aided AAC Sentence Length Measured in Morphemes

    Time frame: 24 Months

07

Study locations

1 of 1 sites recruiting
  • University of Central Florida - Innovative Center
    Orlando, Florida 32826, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — NICHD Data and Specimen Hub

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06512168
Responsible party
Jennifer Kent-Walsh (Pegasus Professor & Associate Dean of Research, University of Central Florida) — Principal investigator
First posted
Jul 22, 2024
Start date
Apr 1, 2025
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
May 16, 2025

Study contacts

Jennifer Kent-Walsh, PhD
Contact
Jkentwalsh@ucf.edu
407-823-4800
Cathy Binger, PhD
Contact
cbinger@unm.edu
505-277-4453

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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