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Addressing Treatment Nonresponders

Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05921227
Enrollment
16
Registered
2023-06-27
Start date
2026-06-30
Completion date
2027-08-31
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Language Development Disorders

Keywords

Late Talkers

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.

Interventions

BEHAVIORALVAULT Phase 6

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

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
University of Arizona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment Effect SizeChange 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 learnedChange 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

MeasureTime frameDescription
Post Treatment RetentionChange 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.

Contacts

Primary ContactMary Alt, PhD
malt@arizona.edu520-626-6180
Backup ContactNora Evans-Reitz, m
nevansreitz@arizona.edu520-626-6885

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026