ClinicalTrials.gg
RecruitingNCT05921214Updated Jul 13, 2026

The Effect of Semantic Support on Word Learning

An interventional study of VAULT Phase 5 in Language Development Disorders, sponsored by University of Arizona. Recruiting at 1 site in United States. Open to participants aged 2 Years to 4 Years. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University of Arizona · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
2 Years to 4 Years
Sex
All
01

Study summary

The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.

Read the detailed description

Children will be assigned to either the familiar or less-familiar word group. All children will receive 8 weeks of Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment (2x/wk for 30 minutes each session). The investigators will measure how well children learn the words they are taught as well as the words that are in the environment, but not explicitly taught (control words). This will help us know if their learning is due to treatment or maturation. The investigators will compare children to themselves (taught words v. control words) to ensure that the overall treatment is working. Then, the investigators will compare children in the familiar word group to children in the less-familiar word group to see which group learns more overall.

02

Conditions studied

  • Language Development Disorders

Keywords

  • Late Talkers
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's planned enrollment of 32 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Native English Speaking
  • Pass pure tone hearing screening or medical report of normal hearing
  • 2-3 Years of age
  • MCDI expressive scale \<10th percentile

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Familiar Words

    In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand at least several words.

    Behavioral: VAULT Phase 5

  • Active comparator
    Less-Familiar Words

    In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand few or no words.

    Behavioral: VAULT Phase 5

Interventions

  • BehavioralVAULT Phase 5

    This is an input-based vocabulary learning treatment based on principles of statistical learning.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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 treatment.

    Time frame: 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 words the child retained from treatment.

    Time frame: Change from end of treatment to follow up, which will average 4-6 weeks.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 17 months after the start.

Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 17 months is below that.

Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2023
First posted
Jun 27, 2023
StartActual
Jun 10, 2025
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 1, 2026
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05921214
Responsible party
Sponsor
First posted
Jun 27, 2023
Start date
Jun 10, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jul 13, 2026

Study contacts

Mary Alt, PhD
Contact
malt@arizona.edu
520-626-6180
Nora Evans-Reitz, MS
Contact
nevansreitz@arizona.edu
520-626-6885
Mary Alt, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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