Skip to main content
Clinical Trials/NCT05921227
NCT05921227
Not Yet Recruiting
Phase 2

Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children

University of Arizona0 sites16 target enrollmentJune 1, 2026

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Language Development Disorders
Sponsor
University of Arizona
Enrollment
16
Primary Endpoint
Treatment Effect Size
Status
Not Yet Recruiting
Last Updated
9 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2026
End Date
August 1, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

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 the treatment.

Secondary Outcomes

  • Post Treatment Retention(Change from end of treatment to follow up, which will average 4-6 weeks.)

Similar Trials