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Building Sentences With Preschoolers Who Use AAC

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ClinicalTrials.gov Identifier: NCT03538925
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
University of New Mexico
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Central Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Down Syndrome Speech and Language Disorder Speech Disorders in Children Speech Intelligibility Speech Sound Disorder Behavioral: AAC Generative Language Intervention Behavioral: Standard of Care / Business as Usual Phase 2

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Word by Word: Building Sentences With Preschoolers Who Use AAC
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

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




Primary Outcome Measures :
  1. Aided AAC Utterance Length [ Time Frame: 6 Months ]
    Aided AAC sentence length measured in morphemes



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Ages Eligible for Study:   3 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538925


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

Locations
United States, Florida
FAAST Center at the University of Central Florida Recruiting
Orlando, Florida, United States, 32826
Contact: Nancy Harrington, MA    407-882-0465    Nancy.Harrington@ucf.edu   
Contact: Jennifer Kent-Walsh, PhD    407-823-4800    jkentwalsh@ucf.edu   
United States, New Mexico
University of New Mexico Department of Speech and Hearing Sciences Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Aimee Bustos, MA    505-277-4453    abusto22@unm.edu   
Contact: Cathy Binger, PhD    505-277-4453    cbinger@unm.edu   
Sponsors and Collaborators
University of Central Florida
University of New Mexico
National Institute on Deafness and Other Communication Disorders (NIDCD)

Responsible Party: University of Central Florida
ClinicalTrials.gov Identifier: NCT03538925     History of Changes
Other Study ID Numbers: 1061417
R01DC016321 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Down Syndrome
Language Disorders
Speech Disorders
Speech Sound Disorder
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Communication Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders