Building Sentences With Preschoolers Who Use AAC
Primary Purpose
Down Syndrome, Speech and Language Disorder, Speech Disorders in Children
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AAC Generative Language Intervention
Standard of Care / Business as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome
Eligibility 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
Sites / Locations
- FAAST Center at the University of Central FloridaRecruiting
- University of New Mexico Department of Speech and Hearing SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Group
Business as Usual
Arm Description
AAC Generative Language Intervention
Standard of Care / Business as Usual
Outcomes
Primary Outcome Measures
Aided AAC Utterance Length
Aided AAC sentence length measured in morphemes
Secondary Outcome Measures
Full Information
NCT ID
NCT03538925
First Posted
May 16, 2018
Last Updated
May 13, 2021
Sponsor
University of Central Florida
Collaborators
University of New Mexico, National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03538925
Brief Title
Building Sentences With Preschoolers Who Use AAC
Official Title
Word by Word: Building Sentences With Preschoolers Who Use AAC
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida
Collaborators
University of New Mexico, National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Speech and Language Disorder, Speech Disorders in Children, Speech Intelligibility, Speech Sound Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
AAC Generative Language Intervention
Arm Title
Business as Usual
Arm Type
Active Comparator
Arm Description
Standard of Care / Business as Usual
Intervention Type
Behavioral
Intervention Name(s)
AAC Generative Language Intervention
Intervention Description
Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care / Business as Usual
Intervention Description
Parent/Caregiver AAC App Operational Training
Primary Outcome Measure Information:
Title
Aided AAC Utterance Length
Description
Aided AAC sentence length measured in morphemes
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Binger, PhD
Phone
505-277-4453
Email
cbinger@unm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Kent-Walsh, PhD
Phone
407-823-4800
Email
jkentwalsh@ucf.edu
Facility Information:
Facility Name
FAAST Center at the University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Harrington, MA
Phone
407-882-0465
Email
Nancy.Harrington@ucf.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Kent-Walsh, PhD
Phone
407-823-4800
Email
jkentwalsh@ucf.edu
Facility Name
University of New Mexico Department of Speech and Hearing Sciences
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Bustos, MA
Phone
505-277-4453
Email
abusto22@unm.edu
First Name & Middle Initial & Last Name & Degree
Cathy Binger, PhD
Phone
505-277-4453
Email
cbinger@unm.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Building Sentences With Preschoolers Who Use AAC
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