Language Development DisordersPhase 2NCT05921227
Addressing Treatment Nonresponders
A Phase 2 study testing VAULT Phase 6 in people with Language Development Disorders, run by University of Arizona.
Trial summary
The goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- VAULT Phase 6
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Aug 2027
- Phase
- Phase 2
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Native English Speaking
- Pass pure tone hearing screening or medical report of normal hearing
- 2-3 years at start of study
- MacArthur-Bates Communicative Development Inventories (MCDI) expressive scale <10th percentile
Who cannot join
- Parental report of other diagnoses
- Enrolled in concurrent treatment elsewhere
- Nonverbal IQ <75 as measured by the Bayley Scales
- Parents unable to consistently bring child to treatment sessions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children
The goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.
Read the detailed description
Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.
- Conditions
- Language Development Disorders
- Being tested
- VAULT Phase 6
- Keywords
- Late Talkers
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAULT Phase 6Behavioural
VAULT is an input-based word learning intervention based on principles of statistical learning.
| Study group | Role | What they receive |
|---|---|---|
| Alternative Treatment Including Augmentative and Alternative Communication | Experimental | Once children are shown to not respond to the usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment, they will be placed in this arm, which will train them to use an Augmentative and Alternative Communication device as an additional means to use to 'say' a word. Receives: Behavioral: VAULT Phase 6 |
| Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment | Active comparator | Children who do appear to respond to treatment will continue with the full course of usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) intervention. Receives: Behavioral: VAULT Phase 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effect Size
The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).
Measured: Change from baseline through treatment, which will average an 8-week time frame.
Number/Rate of words learned
The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment and measured during, immediately following, and 4-6 weeks after the treatment.
Measured: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary outcomes (1)
Post Treatment Retention
We will use probe data or specific words and parental report to determine how many of the words the child retained from treatment.
Measured: Change from end of treatment to follow up, which will average 4-6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- All participants will start in the traditional Vocabulary Acquisition and Usage for Late Talkers (VAULT) model. Those who do not respond to treatment early on will be moved to the Augmentative and Alternative Communication Device arm of the treatment.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Mary Alt, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921227
- Sponsor's protocol ID
- Late Talker Phase 6
- Other IDs
- 2R01DC015642-06
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2023
- Last updated
- 30 Jul 2025
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children
- ClinicalTrials.gov ID
- NCT05921227
- Acronym / sponsor ID
- Late Talker Phase 6
- Conditions
- Language Development Disorders
- Keywords
- Late Talkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Jun 2023 (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 goal of this clinical trial is to see if providing late talking toddlers who are not responding to the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment with a different way of communicating will help them improve their word learning. Participants will start with VAULT word learning treatment. If, in the first few sessions, it looks like they won't respond well, they will be provided with a Big Mack Augmentative and Alternative Communication device (a button that says a word when you press it) to use for their responses. The investigators will see if this modification will help with word learning.
Detailed description
Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial response to treatment, they will be provided with a Big Mack Augmentative and Alternative Communication device which will allow them to 'say' the treatment words with the device. Treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). The investigators will measure word learning across time tracking both spoken productions and productions made with the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- All participants will start in the traditional Vocabulary Acquisition and Usage for Late Talkers (VAULT) model. Those who do not respond to treatment early on will be moved to the Augmentative and Alternative Communication Device arm of the treatment.
| Arm | Type | Receives |
|---|---|---|
| Alternative Treatment Including Augmentative and Alternative Communication | Experimental | Behavioral: VAULT Phase 6Once children are shown to not respond to the usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment, they will be placed in this arm, which will train them to use an Augmentative and Alternative Communication device as an additional means to use to 'say' a word. |
| Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment | Active comparator | Behavioral: VAULT Phase 6Children who do appear to respond to treatment will continue with the full course of usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) intervention. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Native English Speaking
- Pass pure tone hearing screening or medical report of normal hearing
- 2-3 years at start of study
- MacArthur-Bates Communicative Development Inventories (MCDI) expressive scale <10th percentile
Key exclusion criteria (4 listed)
- Parental report of other diagnoses
- Enrolled in concurrent treatment elsewhere
- Nonverbal IQ <75 as measured by the Bayley Scales
- Parents unable to consistently bring child to treatment sessions.
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 |
|---|---|---|
| VAULT Phase 6VAULT is an input-based word learning intervention based on principles of statistical learning. | Behavioural | Alternative Treatment Including Augmentative and Alternative Communication, Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment |
Primary outcome
Treatment Effect Size
Time frame: Change from baseline through treatment, which will average an 8-week time frame.
The investigators will count the number of spontaneous and probed productions of target and control words and calculate a treatment effect size (d).
Number/Rate of words learned
Time frame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
The investigators will measure the number of words learned and rate of words learned as reported by the parent on the MCDI starting prior to treatment and measured during, immediately following, and 4-6 weeks after the treatment.
1 secondary outcome
Post Treatment Retention
Time frame: Change from end of treatment to follow up, which will average 4-6 weeks.
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 30 Jul 2025.
- 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.
Mary Alt, PhD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAULT Phase 6 in people with Language Development Disorders, run by University of Arizona.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Mary Alt, PhD (520-626-6180, malt@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Effect Size (time frame: Change from baseline through treatment, which will average an 8-week time frame.). The study lists 2 primary outcomes in all. 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 30 Jul 2025.