Building Sentences With Preschoolers Who Use AAC

Word by Word: Building Sentences With Preschoolers Who Use AAC

The focus of this investigation is to compare the effectiveness of the AAC Generative Language Intervention approach to an AAC Standard of Care condition on preschool sentence productions. All children will use existing AAC iPad applications.

Study Overview

• Status: Completed
• Conditions: Down Syndrome; Speech Sound Disorder; Speech Disorders in Children; Speech Intelligibility; Speech and Language Disorder
• Intervention / Treatment: Behavioral: AAC Generative Language Intervention; Behavioral: Standard of Care / Business as Usual

Detailed Description

The central hypothesis is that preschoolers receiving AAC Generative Language Intervention will create longer, more grammatically complete sentences compared with the Standard of Care condition. Specific Aim 1 compares these interventions for preschoolers with severe speech impairments and typical receptive language, and Specific Aim 2 does the same for children with Down syndrome. Specific Aim 3 tests for possible moderation of the intervention effect by age, dynamic assessment scores, sentence type, receptive language abilities, prior AAC use, sex, mental age, and disability. Aims 1 and 2 will be accomplished using randomized controlled trials.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

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
      • FAAST Center at the University of Central Florida
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Department of Speech and Hearing Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Clinical Identification of 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; AAC Generative Language Intervention	Behavioral: AAC Generative Language Intervention; Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention; Behavioral: Standard of Care / Business as Usual; Parent/Caregiver AAC App Operational Training
Active Comparator: Business as Usual; Standard of Care / Business as Usual	Behavioral: Standard of Care / Business as Usual; Parent/Caregiver AAC App Operational Training

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	6 Months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Neurodevelopmental Disorders; Abnormalities, Multiple; Chromosome Disorders; Communication Disorders; Down Syndrome; Language Disorders; Speech Disorders; Speech Sound Disorder
• Other Study ID Numbers: 1061417; R01DC016321 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No