Addressing Treatment Nonresponders

Language Development Disorders Clinical Trial

Official title:

Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05921227
• Other study ID #: Late Talker Phase 6
• Secondary ID: 2R01DC015642-06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2025
• Est. completion date: August 2027

Study information

• Verified date: June 2023
• Source: University of Arizona
• Contact: Mary Alt, PhD
• Phone: 520-626-6180
• Email: malt[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: August 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

Inclusion Criteria:

• Native English Speaking

• Pass pure tone hearing screening or medical report of normal hearing

• 2-3 years at start of study

• MacArthur-Bates Communicative Development Inventories (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.

Related Conditions & MeSH terms

• Language Development Disorders

Intervention

Behavioral:
• VAULT Phase 6
VAULT is an input-based word learning intervention based on principles of statistical learning.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Institute on Deafness and Other Communication Disorders (NIDCD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline through treatment, which will average an 8-week time frame.
Primary	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.	Change from Initial Evaluation through Follow-up, which will average a 6-month time frame.
Secondary	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.	Change from end of treatment to follow up, which will average 4-6 weeks.