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NCT03538925 Clinical Trial

Building Sentences With Preschoolers Who Use AAC

Down Syndrome Clinical Trial

Official title:
Word by Word: Building Sentences With Preschoolers Who Use AAC

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03538925
Other study ID # 1061417
Secondary ID R01DC016321
Status Completed
Phase Phase 2
First received
Last updated
Start date May 11, 2018
Est. completion date December 31, 2023

Study information
Verified date January 2024
Source University of Central Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 4 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• AAC Generative Language Intervention
Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention
• Standard of Care / Business as Usual
Parent/Caregiver AAC App Operational Training

Locations
Country Name City State
United States University of New Mexico Department of Speech and Hearing Sciences Albuquerque New Mexico
United States FAAST Center at the University of Central Florida Orlando Florida

Sponsors (3)
Lead Sponsor Collaborator
University of Central Florida National Institute on Deafness and Other Communication Disorders (NIDCD), University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aided AAC Utterance Length Aided AAC sentence length measured in morphemes 6 Months
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