NCT06512168

Brief Summary

The focus of the current study is to systematically investigate the psychometric properties of a range of aided language measures, which are based on the Graphic Symbol Utterance and Sentence Development Framework (Binger \& Kent-Walsh).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Apr 2025Mar 2028

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

July 16, 2024

Last Update Submit

May 13, 2025

Conditions

Keywords

Augmentative and Alternative CommunicationComplex Communication NeedsAssistive TechnologyAAC

Outcome Measures

Primary Outcomes (1)

  • Aided AAC Utterance Length

    Aided AAC Sentence Length Measured in Morphemes

    24 Months

Study Arms (1)

Treatment Group

EXPERIMENTAL

AAC Generative Language Intervention

Behavioral: AAC Generative Language Intervention

Interventions

Aided AAC Language Input/Output Intervention

Treatment Group

Eligibility Criteria

Age42 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical Identification of Down Syndrome or Cerebral Palsy + 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida - Innovative Center

Orlando, Florida, 32826, United States

RECRUITING

MeSH Terms

Conditions

Down SyndromeCerebral PalsyApraxiasSpeech Sound DisorderSpeechLanguage Disorders

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesPsychomotor DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsCommunication DisordersNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Central Study Contacts

Jennifer Kent-Walsh, PhD

CONTACT

Cathy Binger, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pegasus Professor & Associate Dean of Research

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

NICHD Data and Specimen Hub

Locations