Semantic Support for Language Development in Late-Talking Toddlers

Overseen By Nora Evans-Reitz, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Other diagnoses, Concurrent treatment, Low IQ, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how late-talking toddlers learn new words by teaching words from familiar or less familiar categories. The goal is to determine if children learn better from categories they already know, such as animals or body parts, compared to those they don't know well. The treatment, called VAULT Phase 5, involves a word-learning program designed to boost vocabulary. Children who speak English as their first language, have normal hearing, and struggle with verbal expression might be suitable candidates.

As an unphased trial, this study offers a unique opportunity to contribute to understanding language development in toddlers.

Do I need to stop my child's current medications for this trial?

The trial information does not specify whether your child needs to stop taking current medications.

What prior data suggests that the VAULT word learning treatment is safe for late-talking toddlers?

Research has shown that the VAULT Phase 5 treatment is generally easy for children to handle. In a previous study, caregivers delivered the treatment via telehealth, and no major side effects occurred. This suggests the treatment is safe for toddlers who are late in starting to talk. The VAULT treatment helps children understand word meanings and their relationships, further supporting its safety and suitability for young children. Overall, past experiences with the VAULT approach indicate it is a safe and manageable option for aiding language development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to boost language development in late-talking toddlers. Unlike traditional speech therapy that often uses a broad approach, this trial specifically focuses on teaching toddlers new words from semantic categories they are either familiar with or less familiar with, such as animals or body parts. By tailoring word learning to a child's current understanding, the trial could uncover more effective strategies for expanding vocabulary. This targeted method might reveal how familiarity with certain categories can accelerate language acquisition, potentially leading to more personalized and effective language intervention strategies for toddlers.

What evidence suggests that this trial's treatments could be effective for language development in late-talking toddlers?

Research has shown that the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment can help late-talking toddlers improve their spoken vocabulary. Studies have found that this treatment aids children in learning new words more easily, enhancing their overall language skills. For example, one study found that children in the VAULT program experienced a noticeable increase in the number of words they could say. In this trial, participants will be divided into two groups: one focusing on learning Familiar Words from categories they already understand, and another focusing on Less-Familiar Words from categories they know little about. These findings suggest that VAULT could be a promising way to help toddlers learn words, especially when the words are from familiar categories like animals or body parts. ^{5 6 7 8 9}

Who Is on the Research Team?

Mary Alt, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for late-talking toddlers aged 2-3 who speak English natively, have normal hearing, and score below the 10th percentile on expressive language scales. It's not suitable for children outside this age range or with different linguistic and auditory profiles.

Inclusion Criteria

Native English Speaking

Pass pure tone hearing screening or medical report of normal hearing

MCDI expressive scale <10th percentile

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children receive the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment

8 weeks

16 visits (in-person, 2x/week for 30 minutes each)

Follow-up

Participants are monitored for retention and effectiveness of word learning after treatment

4-6 weeks

Extended Follow-up

Participants are monitored for long-term word learning outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• VAULT Phase 5

Trial Overview

The VAULT Phase 5 intervention is being tested to see if teaching words from familiar categories (like animals) helps late-talking toddlers learn more effectively compared to less familiar word categories.

How Is the Trial Designed?

Group I: Familiar Words Experimental Treatment 1 Intervention

In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand at least several words.

Group II: Less-Familiar Words Active Control 1 Intervention

In this condition, children will learn new words that come from semantic categories (e.g., animals, body parts) from which they currently understand few or no words.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

The scoping review aimed to find practical guidance for establishing a pediatric safety specification in drug development but found no existing articles on the topic, highlighting a gap in the literature.

The review emphasizes that a well-defined pediatric safety specification is crucial for developing protocols that ensure safety monitoring, risk management, and appropriate pharmacokinetic studies in pediatric trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review. Aurich, B., Jacqz-Aigrain, E.[2021]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

Approximately 80% of drugs approved by the FDA in the last 30 years have been labeled with disclaimers for use in children, highlighting a significant gap in pediatric drug safety and efficacy studies.

Recent initiatives by the FDA and the National Institute of Child Health and Human Development aim to increase the number of drugs studied and labeled for children, potentially improving access to safe and effective medications for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of drug approval processes and regulation of medications for children. Kauffman, RE.[2019]

The Pediatric Terminology Harmonization Initiative developed a comprehensive adverse event (AE) terminology specifically for pediatric care, containing over 1000 terms related to pediatric diseases and disorders, to improve international reporting and understanding of AEs.

This new terminology is designed for easy integration with existing biomedical vocabularies and is applicable in various healthcare settings, making it a valuable resource for enhancing pediatric clinical research and safety reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. Gipson, DS., Kirkendall, ES., Gumbs-Petty, B., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8608147/

A Vocabulary Acquisition and Usage for Late Talkers ...

This study examined the efficacy of the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment in a version that manipulated the length of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7213481/

Exploring Input Parameters in an Expressive Vocabulary ...

The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers.

3.

repository.arizona.edu

repository.arizona.edu/bitstream/handle/10150/667906/Mettler_et_al_2023_combined.pdf?sequence=1

VAULT CAREGIVER TELEHEALTH 1 2 3 4 5 6 7 Vocabulary ...

T1 = toddler 1. T2 = toddler 2. T3 = toddler 3. T4 = toddler 4. T5 = toddler 5. Participants' rate of word learning was calculated by (2nd ...

4.

ldbase.org

ldbase.org/system/files/documents/2024-12/VAULT_TALK_Codebook_Guide_Wave1.pdf

Codebook Guide for A Longitudinal Assessment of Late- ...

Data Collection and Usage. Data were collected longitudinally, tracking the development of late-talking toddlers who underwent the VAULT treatment protocol.

5.

asha.figshare.com

asha.figshare.com/articles/journal_contribution/Effect_of_VAULT_treatment_Munro_et_al_2021_/14714733

Effect of VAULT treatment (Munro et al., 2021) - ASHA journals

This study examined the effect of Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment on toddlers' expressive vocabulary and phonology.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10023173/

Vocabulary Acquisition and Usage for Late Talkers

This feasibility study examined a caregiver-implemented telehealth model of the Vocabulary Acquisition and Usage for Late Talkers (VAULT) protocol.

7.

withpower.com

withpower.com/trial/semantic-support-for-language-development-in-late-talking-toddlers-a200e

Semantic Support for Language Development in Late ...

The VAULT Phase 5 treatment is unique because it focuses on enhancing semantic support, which involves understanding the meaning and relationships between words ...

8.

ldbase.org

ldbase.org/datasets/7cf128e3-dd11-4ed3-98f1-078f7a70e199

Dataset: Longitudinal Assessment of Late Talking Toddlers

This dataset contains the data from the overarching project that was collected via the Vocabulary Acquisition and Usage for Late Talkers (VAULT) protocol.

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05921227

NCT05921227 | Addressing Treatment Nonresponders

Children will begin Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment. If, after three sessions, they do not show an initial ...