Measuring Aided Language Development (MALD)

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).

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Down Syndrome; Apraxia of Speech; Speech Sound Disorder; Speech Disorders in Children; Speech and Language Disorder
• Intervention / Treatment: Behavioral: AAC Generative Language Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cathy Binger, PhD; Phone Number: 505-277-4453; Email: cbinger@unm.edu
• Study Contact Backup: Name: Jennifer Kent-Walsh, PhD; Phone Number: 407-823-4800; Email: Jkentwalsh@ucf.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32826
      • Recruiting
      • University of Central Florida - Innovative Center
      • Contact: Nancy Harrington, MA; Phone Number: (407) 882-0465; Email: nancy.harrington@ucf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; AAC Generative Language Intervention	Behavioral: AAC Generative Language Intervention; Aided AAC Language Input/Output Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aided AAC Utterance Length	Aided AAC Sentence Length Measured in Morphemes	24 Months

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD); University of Wisconsin, Milwaukee; University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Assistive Technology; AAC; Augmentative and Alternative Communication; Complex Communication Needs
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Congenital Abnormalities; Neurodevelopmental Disorders; Abnormalities, Multiple; Brain Damage, Chronic; Intellectual Disability; Chromosome Disorders; Psychomotor Disorders; Communication Disorders; Cerebral Palsy; Language Disorders; Speech Disorders; Down Syndrome; Apraxias; Speech Sound Disorder
• Other Study ID Numbers: AWD00006137; 1R01DC021160-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NICHD Data and Specimen Hub

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