Addressing Treatment Nonresponders

NCT05921227 | Not Yet Recruiting Phase 2

• 2 other identifiers: Late Talker Phase 62R01DC015642-06
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Language Development Disorders

Keywords

Late Talkers

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Post Treatment Retention

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

Study Arms (2)

Alternative Treatment Including Augmentative and Alternative Communication

EXPERIMENTAL

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.

Behavioral: VAULT Phase 6

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

ACTIVE COMPARATOR

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.

Behavioral: VAULT Phase 6

Interventions

VAULT Phase 6 BEHAVIORAL

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

Alternative Treatment Including Augmentative and Alternative Communication; Usual Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Native English Speaking
• Pass pure tone hearing screening or medical report of normal hearing
• years at start of study
• MacArthur-Bates Communicative Development Inventories (MCDI) expressive scale \<10th percentile

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Mary Alt, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Alt, PhD

CONTACT

520-626-6180; malt@arizona.edu

Nora Evans-Reitz, m

CONTACT

520-626-6885; nevansreitz@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 27, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share