- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05921214
The Effect of Semantic Support on Word Learning
July 9, 2026 updated by: University of Arizona
Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary Alt, PhD
- Phone Number: 520-626-6180
- Email: malt@arizona.edu
Study Contact Backup
- Name: Nora Evans-Reitz, MS
- Phone Number: 520-626-6885
- Email: nevansreitz@arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- Recruiting
- University of Arizona
-
Contact:
- Nora Evans-Reitz, M.S.
- Phone Number: 520-626-6885
- Email: nevansreitz@arizona.edu
-
Contact:
- Cecilia Figueroa, M.S.
- Phone Number: 520-626-6885
- Email: cecilm@arizona.edu
-
Principal Investigator:
- Mary Alt, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
This is an input-based vocabulary learning treatment based on principles of statistical learning.
|
|
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.
|
This is an input-based vocabulary learning treatment based on principles of statistical learning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Change from baseline through treatment, which will average an 8-week time frame.
|
|
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 treatment.
|
Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post Treatment Retention
Time Frame: Change from end of treatment to follow up, which will average 4-6 weeks.
|
The investigators will use probe data and parental report to determine how many words the child retained from treatment.
|
Change from end of treatment to follow up, which will average 4-6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary Alt, PhD, University of Arizona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
June 26, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
July 13, 2026
Last Update Submitted That Met QC Criteria
July 9, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Late Talker Phase 5
- 2R01DC015642-06 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.