Down SyndromePhase 2NCT03538925
Building Sentences With Preschoolers Who Use AAC
A Phase 2 study testing AAC Generative Language Intervention in people with Down Syndrome and Speech and Language Disorder, run by University of Central Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Speech and Language Disorder, Speech Disorders in Children
- 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
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2018to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Clinical Diagnosis of Autism or Social Communication Disorder
- Primary Language Spoken is a Language Other than English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico Department of Speech and Hearing Sciences
Albuquerque, New Mexico, 87131
FAAST Center at the University of Central Florida
Orlando, Florida, 32826
About this study
Official title: Word by Word: Building Sentences With Preschoolers Who Use AAC
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.
Read the detailed description
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
- Down Syndrome, Speech and Language Disorder, Speech Disorders in Children, Speech Intelligibility, Speech Sound Disorder
- Being tested
- AAC Generative Language Intervention, Standard of Care / Business as Usual
- Medical subject headings
- Down Syndrome, Speech, Language Disorders, Speech Intelligibility, Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAC Generative Language InterventionBehavioural
Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention
Standard of Care / Business as UsualBehavioural
Parent/Caregiver AAC App Operational Training
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | AAC Generative Language Intervention Receives: Behavioral: AAC Generative Language Intervention; Behavioral: Standard of Care / Business as Usual |
| Business as Usual | Active comparator | Standard of Care / Business as Usual Receives: Behavioral: Standard of Care / Business as Usual |
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: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start11 May 2018
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538925
- Sponsor's protocol ID
- 1061417
- Other IDs
- R01DC016321
- Status last verified
- Jan 2024
- First submitted
- 16 May 2018
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Word by Word: Building Sentences With Preschoolers Who Use AAC
- ClinicalTrials.gov ID
- NCT03538925
- Acronym / sponsor ID
- 1061417
- Conditions
- Down Syndrome, Speech and Language Disorder, Speech Disorders in Children, Speech Intelligibility, Speech Sound Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- University of New Mexico, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 11 May 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 May 2018 (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 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: AAC Generative Language Intervention, Behavioral: Standard of Care / Business as UsualAAC Generative Language Intervention |
| Business as Usual | Active comparator | Behavioral: Standard of Care / Business as UsualStandard of Care / Business as Usual |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
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 InterventionParent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention | Behavioural | Treatment Group |
| Standard of Care / Business as UsualParent/Caregiver AAC App Operational Training | Behavioural | Business as Usual, Treatment Group |
Primary outcome
Aided AAC Utterance Length
Time frame: 6 Months
Aided AAC sentence length measured in morphemes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AAC Generative Language Intervention in people with Down Syndrome and Speech and Language Disorder, run by University of Central Florida at 2 sites 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: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aided AAC Utterance Length (time frame: 6 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 8 Jan 2024.