NCT05921227

Addressing Treatment Nonresponders

Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Language Development Disorders

Interventions

Type	Name	Description
BEHAVIORAL	VAULT Phase 6	VAULT is an input-based word learning intervention based on principles of statistical learning.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2023-06-27
• Last updated: 2025-07-30