A Phase 2 interventional study of VAULT Phase 6 in Language Development Disorders, sponsored by University of Arizona. Not yet recruiting. Open to participants aged 2 Years to 4 Years. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by University of Arizona · Phase 2, Interventional, and Treatment
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.
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.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 16 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
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Exclusion Criteria:
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.
Behavioral: VAULT Phase 6
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.
Behavioral: VAULT Phase 6
VAULT is an input-based word learning intervention based on principles of statistical learning.
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).
Time frame: 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.
Time frame: Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
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.
Time frame: Change from end of treatment to follow up, which will average 4-6 weeks.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Language Development Disorders →