Addressing Treatment Nonresponders

Sponsor

University of Arizona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05921227

Collaborator

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

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Language Development Disorders	Behavioral: VAULT Phase 6	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

Double (Participant, Care Provider)

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.

Primary Purpose:

Treatment

Official Title:

Identification of Treatment Parameters the Maximize Language Treatment Efficacy for Children

Anticipated Study Start Date :

Jun 1, 2025

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: VAULT Phase 6 VAULT is an input-based word learning intervention based on principles of statistical learning.
Active Comparator: 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.	Behavioral: VAULT Phase 6 VAULT is an input-based word learning intervention based on principles of statistical learning.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: VAULT Phase 6

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

Active Comparator: 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.

Behavioral: VAULT Phase 6

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

Outcome Measures

Primary Outcome Measures

Treatment Effect Size [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).
Number/Rate of words learned [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 Outcome Measures

Post Treatment Retention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 4 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Mary Alt, PhD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arizona

ClinicalTrials.gov Identifier:

NCT05921227

Other Study ID Numbers:

Late Talker Phase 6
2R01DC015642-06

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Arizona

Late Talkers

Additional relevant MeSH terms:

Language Development Disorders

Study Results

No Results Posted as of Jun 27, 2023