Down SyndromeMALDNCT06512168
Measuring Aided Language Development
A study testing AAC Generative Language Intervention in people with Down Syndrome and Cerebral Palsy, run by University of Central Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 42 to 60 months
- Conditions the study is for
- Down Syndrome, Cerebral Palsy, Apraxia of Speech
- What is being tested?
- AAC Generative Language Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Clinical Diagnosis of Autism or Social Communication Disorder
- Primary Language Spoken is A Language Other than English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida - Innovative Center
Orlando, Florida, 32826
Nancy Harrington, MA, (407) 882-0465, nancy.harrington@ucf.edu
About this study
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).
Read the detailed description
Our central hypotheses are: (1) psychometrically sound measures can be established to capture growth within and across different dimensions of language acquisition, and (2) some elicitation contexts will be better than others at capturing aided language growth. Specific Aim 1 identifies valid measures to characterize aided language progress. Aim 1A uses existing data to document the psychometric properties of a range of aided language measures for preschoolers at the early stages of aided communication acquisition who have received 4 months of aided language intervention. Aim 1B analyzes language progression for high-performing aided communicators who will receive 24 months of intervention; this allows for investigation across all phases of early aided language acquisition. Specific Aim 2 identifies elicitation contexts that demonstrate the most productive aided language use. Achievement of the aims will result in measures that demonstrate strong reliability, differentiate growth for different populations, describe different dimensions of language growth, and are clinically feasible.
- Conditions
- Down Syndrome, Cerebral Palsy, Apraxia of Speech, Speech Sound Disorder, Speech Disorders in Children, Speech and Language Disorder
- Being tested
- AAC Generative Language Intervention
- Keywords
- Augmentative and Alternative Communication, Complex Communication Needs, Assistive Technology, AAC
- Medical subject headings
- Down Syndrome, Cerebral Palsy, Apraxias, Speech Sound Disorder, Speech, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAC Generative Language InterventionBehavioural
Aided AAC Language Input/Output Intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | AAC Generative Language Intervention Receives: Behavioral: AAC Generative Language Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aided AAC Utterance Length
Aided AAC Sentence Length Measured in Morphemes
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Apr 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of New Mexico, University of Wisconsin, Milwaukee
- Responsible party
- Principal investigator, Jennifer Kent-Walsh, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512168
- Sponsor's protocol ID
- AWD00006137
- Other IDs
- 1R01DC021160-01A1
- Acronym
- MALD
- Status last verified
- May 2025
- First submitted
- 16 Jul 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NICHD Data and Specimen Hub
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Aided Language Development
- ClinicalTrials.gov ID
- NCT06512168
- Acronym / sponsor ID
- MALD / AWD00006137
- Conditions
- Down Syndrome, Cerebral Palsy, Apraxia of Speech, Speech Sound Disorder, Speech Disorders in Children, Speech and Language Disorder
- Keywords
- Augmentative and Alternative Communication, Complex Communication Needs, Assistive Technology, AAC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of New Mexico, University of Wisconsin, Milwaukee
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Our central hypotheses are: (1) psychometrically sound measures can be established to capture growth within and across different dimensions of language acquisition, and (2) some elicitation contexts will be better than others at capturing aided language growth. Specific Aim 1 identifies valid measures to characterize aided language progress. Aim 1A uses existing data to document the psychometric properties of a range of aided language measures for preschoolers at the early stages of aided communication acquisition who have received 4 months of aided language intervention. Aim 1B analyzes language progression for high-performing aided communicators who will receive 24 months of intervention; this allows for investigation across all phases of early aided language acquisition. Specific Aim 2 identifies elicitation contexts that demonstrate the most productive aided language use. Achievement of the aims will result in measures that demonstrate strong reliability, differentiate growth for different populations, describe different dimensions of language growth, and are clinically feasible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: AAC Generative Language InterventionAAC Generative Language Intervention |
Who may qualify
- Ages
- 42 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Clinical Diagnosis of Autism or Social Communication Disorder
- Primary Language Spoken is A Language Other than English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAC Generative Language InterventionAided AAC Language Input/Output Intervention | Behavioural | Treatment Group |
Primary outcome
Aided AAC Utterance Length
Time frame: 24 Months
Aided AAC Sentence Length Measured in Morphemes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. NICHD Data and Specimen Hub
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAC Generative Language Intervention in people with Down Syndrome and Cerebral Palsy, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Kent-Walsh, PhD (407-823-4800, Jkentwalsh@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aided AAC Utterance Length (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.