Addressing Treatment Nonresponders

University of Arizona

Status and phase: Begins enrollment in 5 months; Phase 2

Conditions: Language Development Disorders

Treatments: Behavioral: VAULT Phase 6

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05921227

Late Talker Phase 6

2R01DC015642-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 2 to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Alternative Treatment Including Augmentative and Alternative Communication

Experimental group

Description:

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.

Treatment:

Behavioral: VAULT Phase 6

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

Active Comparator group

Description:

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.

Treatment:

Behavioral: VAULT Phase 6