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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.

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 data supports the effectiveness of the VAULT treatment for language development in late-talking toddlers?

The VAULT treatment has been shown to effectively increase the spoken vocabulary of late-talking toddlers, with an average treatment effect size of almost 1.0 compared to no treatment. Additionally, toddlers in the study increased their expressive vocabulary by an average of 16 words per week, and parents found the treatment acceptable. ^{1 2 3 4 5}

Is the treatment Semantic Support for Language Development in Late-Talking Toddlers safe for children?

The research articles provided do not contain specific safety data for the treatment Semantic Support for Language Development in Late-Talking Toddlers or its related names like VAULT Phase 5. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How is the VAULT Phase 5 treatment different from other treatments for late-talking toddlers?

The VAULT Phase 5 treatment is unique because it focuses on enhancing semantic support, which involves understanding the meaning and relationships between words, to aid language development in late-talking toddlers. This approach is different from other treatments that may not specifically target the semantic aspects of language acquisition. ^{11 12 13 14 15}

Research Team

Mary Alt, PhD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vocabulary Acquisition and Usage for Late Talkers: The Feasibility of a Caregiver-Implemented Telehealth Model. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Vocabulary Acquisition and Usage for Late Talkers Treatment Efficacy Study: The Effect of Input Utterance Length and Identification of Responder Profiles. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Risk and Protective Factors for Late Talking: An Epidemiologic Investigation. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Exploring Input Parameters in an Expressive Vocabulary Treatment With Late Talkers. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Vocabulary Acquisition and Usage for Late Talkers Treatment: Effect on Expressive Vocabulary and Phonology. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Development of a Pediatric Adverse Events Terminology. [2019]

7. Switzerland 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. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Paediatric Clinical Trial Characteristics and Activity Over 23 Years-Impact of the European Paediatric Regulation on a Single French Clinical Research Center. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

11. United States pubmed.ncbi.nlm.nih.gov

Difference or delay? Syntax, semantics, and verb vocabulary development in typically developing and late-talking toddlers. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Sensitivity to Semantic Relationships in U.S. Monolingual English-Speaking Typical Talkers and Late Talkers. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Implicit meaning in 18-month-old toddlers. [2014]

14. United States pubmed.ncbi.nlm.nih.gov

Lexico-semantic structure in vocabulary and its links to lexical processing in toddlerhood and language outcomes at age three. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Lexical-semantic immaturities manifesting as grammatical disorders: evidence from a child language sample. [2009]