Building Sentences With Preschoolers Who Use AAC

NCT03538925 | Completed Phase 2

• 2 other identifiers: 1061417R01DC016321
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Aided AAC Utterance Length

  Aided AAC sentence length measured in morphemes

  6 Months

Study Arms (2)

Treatment Group

EXPERIMENTAL

AAC Generative Language Intervention

Behavioral: AAC Generative Language Intervention; Behavioral: Standard of Care / Business as Usual

Business as Usual

ACTIVE COMPARATOR

Standard of Care / Business as Usual

Behavioral: Standard of Care / Business as Usual

Interventions

AAC Generative Language Intervention BEHAVIORAL

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

Treatment Group

Standard of Care / Business as Usual BEHAVIORAL

Parent/Caregiver AAC App Operational Training

Business as Usual; Treatment Group

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Clinical Diagnosis of Autism or Social Communication Disorder
• Primary Language Spoken is a Language Other than English

Sponsors & Collaborators

• University of Central Florida: lead
• University of New Mexico: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

FAAST Center at the University of Central Florida

Orlando, Florida, 32826, United States

Location

University of New Mexico Department of Speech and Hearing Sciences

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Down Syndrome; Speech; Language Disorders; Speech Intelligibility; Speech Sound Disorder

Interventions

Standard of Care; Commerce

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Verbal Behavior; Communication; Behavior; Communication Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: May 11, 2018
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)