Who is sponsoring NCT03538925?

NCT03538925 is sponsored by University of Central Florida.

What drugs are being tested in NCT03538925?

Interventions in NCT03538925: AAC Generative Language Intervention, Standard of Care / Business as Usual.

What condition does NCT03538925 study?

NCT03538925 studies Down Syndrome, Speech and Language Disorder, Speech Disorders in Children, Speech Intelligibility, Speech Sound Disorder.

Is NCT03538925 still recruiting?

NCT03538925 is currently completed. Last updated 8 January 2024.

Last reviewed 2024-01-08 · How we verify

NCT03538925

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Building Sentences With Preschoolers Who Use AAC

Completed Phase 2 Last updated 8 January 2024

What this trial tests

Phase 2 trial testing AAC Generative Language Intervention in Down Syndrome in 70 participants. Completed in 31 December 2023.

Timeline

11 May 2018

Primary endpoint
30 June 2023

31 December 2023

Quick facts

Lead sponsor	University of Central Florida
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	70
Start date	11 May 2018
Primary completion	30 June 2023
Estimated completion	31 December 2023
Sites	2 locations across United States

Drugs / interventions tested

AAC Generative Language Intervention
Standard of Care / Business as Usual

Conditions studied

Down Syndrome — all drugs for Down Syndrome →
Speech and Language Disorder — all drugs for Speech and Language Disorder →
Speech Disorders in Children — all drugs for Speech Disorders in Children →
Speech Intelligibility — all drugs for Speech Intelligibility →

Sponsor

University of Central Florida

Who can join

Adults 3 to 4, any sex, with Down Syndrome or Speech and Language Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Generative Language Intervention for Young Children With Down Syndrome Using Augmentative and Alternative Communication: A Randomized Controlled Trial.
Kent-Walsh J, Harrington N, Hahs-Vaughn D, Binger C. · · 2025 · cited 1× · PMID 40587257 · DOI 10.1044/2025_lshss-24-00117

Verify or expand the search:

Other trials of AAC Generative Language Intervention

Trials testing the same drug.

NCT06512168 — Measuring Aided Language Development · NA · recruiting

Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

NCT07416201 — Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy · recruiting
NCT07484464 — Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome · NA · recruiting
NCT07428863 — Effects of Jump Rope on Navicular Drop in Down Syndrome · NA · recruiting
NCT07260136 — Cervical Spine Abnormalities in Down Syndrome · active not recruiting
NCT07248449 — Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises · NA · recruiting

Other University of Central Florida trials

Trials by the same sponsor.

NCT07203430 — Biopsychosocial Factors and Muscle Morphology After a Resistance Exercise · NA · completed
NCT07214883 — UCF MammoChat: Image Repository · recruiting
NCT06999057 — Quadriceps Motor Unit Adaptation to Simulated Knee Injury · NA · not yet recruiting
NCT06979713 — Yoga, Education, and Nidra (YEN) for Chronic Low Back Pain: A Pilot Study on Pain Modulation, Well-Being, and Sleep · NA · not yet recruiting
NCT06512168 — Measuring Aided Language Development · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03538925 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Central Florida
Last refreshed: 8 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03538925.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing