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NCT Number: NCT05921227

Addressing Treatment Nonresponders

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.

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Key information

Conditions

Language Development Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VAULT Phase 6

Behavioral

VAULT is an input-based word learning intervention based on principles of statistical learning.

Primary outcomes

  1. 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).

  2. 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

  1. Post Treatment Retention

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

    We will use probe data or specific words and parental report to determine how many of the words the child retained from treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Alt, PhD

CONTACT

[email protected]

520-626-6180

Nora Evans-Reitz, m

CONTACT

[email protected]

520-626-6885

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2023
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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