Building Sentences With Preschoolers Who Use AAC

NCT ID: NCT03538925

Last Updated: 2024-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-11

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Down Syndrome Speech and Language Disorder Speech Disorders in Children Speech Intelligibility Speech Sound Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Treatment Group

AAC Generative Language Intervention

Group Type EXPERIMENTAL

AAC Generative Language Intervention

Intervention Type BEHAVIORAL

Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention

Standard of Care / Business as Usual

Intervention Type BEHAVIORAL

Parent/Caregiver AAC App Operational Training

Business as Usual

Standard of Care / Business as Usual

Group Type ACTIVE_COMPARATOR

Standard of Care / Business as Usual

Intervention Type BEHAVIORAL

Parent/Caregiver AAC App Operational Training

Interventions

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AAC Generative Language Intervention

Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention

Intervention Type BEHAVIORAL

Standard of Care / Business as Usual

Parent/Caregiver AAC App Operational Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Mexico

OTHER

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FAAST Center at the University of Central Florida

Orlando, Florida, United States

Site Status

University of New Mexico Department of Speech and Hearing Sciences

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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R01DC016321

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1061417

Identifier Type: -

Identifier Source: org_study_id

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