Addressing Treatment Nonresponders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-08-31

Brief Summary

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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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Detailed Description

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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

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Language Development Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

All participants will start in the traditional Vocabulary Acquisition and Usage for Late Talkers (VAULT) model. Those who do not respond to treatment early on will be moved to the Augmentative and Alternative Communication Device arm of the treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

The children and their caregivers will not be told which condition they are assigned to. However, the Augmentative and Alternative Communication device is quite obvious, so although caregivers will not be explicitly told, it is likely they will be aware their child is in that arm.

Study Groups

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Alternative Treatment Including Augmentative and Alternative Communication

Once children are shown to not respond to the usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment, they will be placed in this arm, which will train them to use an Augmentative and Alternative Communication device as an additional means to use to 'say' a word.

Group Type EXPERIMENTAL

VAULT Phase 6

Intervention Type BEHAVIORAL

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

Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment

Children who do appear to respond to treatment will continue with the full course of usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) intervention.

Group Type ACTIVE_COMPARATOR

VAULT Phase 6

Intervention Type BEHAVIORAL

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

Interventions

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VAULT Phase 6

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No