VOCAB + for Developmental Delay

(VOCAL+ Trial)

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mariana Silva

Disqualifiers: Sensory impairments, Autism, Traumatic brain injury

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain word features and spellings affect vocabulary learning in children with low oral language skills. The goal is to enhance how efficiently these children learn new words over a 12-week period. Every participant will receive the same treatment, VOCAB +, a vocabulary enhancement program focusing on real words rather than made-up ones. Children who may be suitable typically score 85 or lower on a common language skills test and are in or have just finished third grade, without any sensory impairments or diagnoses such as autism or traumatic brain injury. As an Early Phase 1 trial, this study aims to understand how the vocabulary enhancement program functions in children, offering participants a chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this method is safe for children with low oral language levels?

Research on VOCAB + has not yet provided specific safety data for this treatment. As this is a new study, detailed safety information might not be available. Since VOCAB + is being tested in an early-phase study, it remains in the initial stages of safety evaluation. Early-phase trials typically focus on understanding the treatment's effects on people, including any side effects.

Early-phase studies are generally designed to monitor participants closely, ensuring that any potential risks are identified quickly. Participants often report how they feel, and researchers watch for any unexpected effects.

For those considering joining this trial, the research team will closely monitor safety, support participants, and address any concerns during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

VOCAB + is unique because it specifically targets developmental delay by enriching vocabulary skills, a novel approach compared to traditional therapies that focus on broader developmental areas. Most treatments for developmental delay emphasize behavioral interventions or general cognitive therapies, but VOCAB + zeroes in on language acquisition as a key to overall development. Researchers are excited because this targeted strategy could lead to faster and more significant improvements in language and cognitive skills, potentially transforming how developmental delays are addressed.

What evidence suggests that VOCAB + might be an effective treatment for developmental delay?

Studies have shown that vocabulary programs can greatly enhance spoken vocabulary in children with developmental delays. For instance, children in communication support programs often use more target vocabulary words. Although some programs have shown small decreases in skills like understanding and using words, the overall research trend remains positive. These programs often use simple tests, such as naming pictures, to measure success. This evidence suggests that focusing on vocabulary can aid children with low language skills in improving their language development. Participants in this trial will receive the VOCAB + intervention, which aims to build on these positive outcomes. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children with developmental delays and low oral language levels. It's designed to explore how they learn new vocabulary based on different word characteristics and the presence of written words.

Inclusion Criteria

My CELF score is 85 or lower and I am in or just finished third grade.

Exclusion Criteria

Diagnosis of autism

I have a diagnosed sensory impairment.

I have been diagnosed with a traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a vocabulary intervention focusing on word characteristics and orthography

12 weeks

Follow-up

Participants are monitored for vocabulary retention and learning efficiency after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VOCAB +

Trial Overview

The study tests 'VOCAB +', a method that looks at the impact of word traits like sound patterns, along with whether seeing the words written down helps kids remember them better. All participants will experience each variation over a 12-week period.

How Is the Trial Designed?

Group I: Single group Assignment Experimental Treatment 1 Intervention

There are no subgroups in this study. All participants will receive the intervention.

Who Is Running the Clinical Trial?

Mariana Silva

Lead Sponsor

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Published Research Related to This Trial

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]

Big data (BD) in pediatric medication safety research offers significant opportunities to enhance the safety and health of children, especially as legislation has increased the number of pediatric trials over the past 20 years.

Traditional clinical trials often fail to represent the general pediatric population or detect rare safety signals, but BD can address these limitations by utilizing digitized medical records and large databases to provide more comprehensive safety data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Big Data in the Assessment of Pediatric Medication Safety. McMahon, AW., Cooper, WO., Brown, JS., et al.[2020]

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]

There is a significant lack of knowledge regarding the long-term health impacts of novel targeted and immunotherapy agents used in children with cancer, despite advancements in understanding the toxicities of traditional treatments like surgery, radiation, and chemotherapy.

The ACCELERATE initiative aims to create an international registry to collect long-term follow-up data on these therapies, which will help ensure safety, support regulatory requirements, and guide treatment decisions for pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. Kieran, MW., Caron, H., Winther, JF., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8702839/

Spoken Vocabulary Outcomes of Toddlers With ...

Participation in AAC intervention resulted in significantly more spoken target vocabulary words and no statistically significant differences in speech sound ...

2.

pubs.asha.org

pubs.asha.org/doi/abs/10.1044/2020_AJSLP-20-00093

Spoken Vocabulary Outcomes of Toddlers With ...

AAC intervention resulted in significantly more spoken target vocabulary words, with no significant difference in speech sound errors compared to spoken ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0021992423000266

Effects in language development of young children with ...

A few children showed a decrease in language skills, namely in receptive syntax (1%), receptive vocabulary (3%) and expressive vocabulary (2%).

4.

frontiersin.org

frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2025.1517311/full

Vocabulary interventions for children with developmental ...

The most common outcome measure was expressive target-word tests, such as picture naming and word definitions. Interventions explicitly ...

5.

kutestkids.com

kutestkids.com/blog/statistics-on-speech-delay-outcomes

Impactful Statistics on Speech Delay Outcomes

15.6% of 3-year-olds have SSD, 1 in 12 (3-17) have speech/language issues, 8% have language impairment, and 30-60% have reading/spelling issues.

6.

withpower.com

withpower.com/trial/early-phase-1-developmental-child-delay-1-2025-5d136

VOCAB + for Developmental Delay · Info for Participants

What safety data exists for VOCAB + or similar treatments in humans? There is ongoing research to improve the safety of medications in children, including ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0145213423004362

Developmental trajectories of speech and language in ...

Data were collected at six-month intervals between the ages of 3 and 5.5 years using psychometrically robust tools. Neglected and control groups were ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8156743/

Developmental Language Disorder: Early Predictors, Age for ...

Those children (10%), who were unable to cooperate in the screening at age 2;5, had an increased risk for DLD and should be carefully monitored. 3.2.3. Q1: ...