Language Development DisordersPhase 2NCT05921188
The Effect of Prior Learning on Word Learning
A Phase 2 study testing VAULT Phase 4 in people with Language Development Disorders, run by University of Arizona at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. 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 4
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 6 Jun 2025
- 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 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 of age at start of study
- MCDI expressive scales <10th percentile
Who cannot join
- Parental reports 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
1 site in 1 country.
About this study
Official title: Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children
The goal of this clinical trial is to compare two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. The investigators see which group learns more, to understand if choosing words that let children use the knowledge they already have helps with learning.
Read the detailed description
Late talking toddlers will be assigned to be in the More Familiar Sounds condition or the Less Familiar Sounds condition. Both groups will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/week for 30 minutes per session) using their words. The investigators will compare learning within children (taught words v. control words that are not explicitly taught) to make sure the learning that is happening is due to the treatment and not just maturation. The investigators will compare across groups to see if the group treated with More Familiar Sounding words learns more than the group treated with Less Familiar Sounding words.
- Conditions
- Language Development Disorders
- Being tested
- VAULT Phase 4
- 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 4Behavioural
Children will receive an input-based word learning treatment that is designed based on principles of statistical learning.
| Study group | Role | What they receive |
|---|---|---|
| More Familiar Sounds | Experimental | Children in this condition will learn new words whose sounds are more like the sounds in the words the child already understands. Receives: Behavioral: VAULT Phase 4 |
| Less Familiar Sounds | Active comparator | Children in this condition will learn new words whose sounds are less like the sounds in the words the child already understands. Receives: Behavioral: VAULT Phase 4 |
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 the 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
The investigators will use probe data 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 start1 Jun 2023
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will use treatment effect sizes to compare children to themselves (treatment v. control) and across groups (More Familiar Sounds v. Less Familiar Sounds).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 participants (actual)
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
- NCT05921188
- Sponsor's protocol ID
- Late Talker Phase 4
- Other IDs
- 2R01DC015642-06
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2023
- Last updated
- 27 Jun 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Treatment Parameters That Maximize Language Treatment Efficacy for Children
- ClinicalTrials.gov ID
- NCT05921188
- Acronym / sponsor ID
- Late Talker Phase 4
- Conditions
- Language Development Disorders
- Keywords
- Late Talkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- 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 compare two treatment conditions for late talking toddlers. In 8 weeks of word learning treatment, toddlers will be taught words that sound more like the words they already know or sound less like the words they already know. The investigators see which group learns more, to understand if choosing words that let children use the knowledge they already have helps with learning.
Detailed description
Late talking toddlers will be assigned to be in the More Familiar Sounds condition or the Less Familiar Sounds condition. Both groups will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/week for 30 minutes per session) using their words. The investigators will compare learning within children (taught words v. control words that are not explicitly taught) to make sure the learning that is happening is due to the treatment and not just maturation. The investigators will compare across groups to see if the group treated with More Familiar Sounding words learns more than the group treated with Less Familiar Sounding words.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The investigators will use treatment effect sizes to compare children to themselves (treatment v. control) and across groups (More Familiar Sounds v. Less Familiar Sounds).
| Arm | Type | Receives |
|---|---|---|
| More Familiar Sounds | Experimental | Behavioral: VAULT Phase 4Children in this condition will learn new words whose sounds are more like the sounds in the words the child already understands. |
| Less Familiar Sounds | Active comparator | Behavioral: VAULT Phase 4Children in this condition will learn new words whose sounds are less like the sounds in the words the child already understands. |
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 of age at start of study
- MCDI expressive scales <10th percentile
Key exclusion criteria (4 listed)
- Parental reports 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 4Children will receive an input-based word learning treatment that is designed based on principles of statistical learning. | Behavioural | Less Familiar Sounds, More Familiar Sounds |
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 the 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
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 27 Jun 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. This study is not recruiting at the moment.
Mary Alt, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VAULT Phase 4 in people with Language Development Disorders, run by University of Arizona 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 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: finished, as of the sponsor's last update on 27 Jun 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.
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?
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 27 Jun 2025.