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

23 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate how word characteristics (e.g., phonotactic probability) and orthography affect vocabulary by children with low oral language levels. The investigators will use a 2 x 2 within-subjects factorial design where every participant receives the treatment. This 12-week study aims to improve vocabulary learning efficiency for children with low oral language levels. The study's findings will uniquely contribute to the field in that this is the first research study using real words instead of nonwords while combining word learning research with vocabulary learning.

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 data supports the effectiveness of the treatment VOCAB + for developmental delay?

Research shows that language interventions, including parent-coached programs and operant procedures, can improve vocabulary and communication skills in children with developmental delays. These findings suggest that similar treatments like VOCAB + may also be effective in enhancing language development in these children. ^{1 2 3 4 5}

What safety data exists for VOCAB + or similar treatments in humans?

There is ongoing research to improve the safety of medications in children, including the use of big data to better understand medication effects and long-term safety. Additionally, efforts are being made to collect long-term safety data on new therapies, which can help guide treatment decisions and inform safety labeling. ^{6 7 8 9 10}

How does the VOCAB + treatment differ from other treatments for developmental delay?

VOCAB + is unique because it uses operant procedures to improve vocabulary in developmentally delayed children, focusing on generalizing learned words to untrained vocabulary. This approach is different from traditional methods as it emphasizes behavioral techniques and caregiver involvement to enhance language skills in home settings. ^{4 5 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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. England pubmed.ncbi.nlm.nih.gov

Early Intervention for Children with Intellectual Disabilities: An Update. [2022]

2. Israel pubmed.ncbi.nlm.nih.gov

[Epidemiology of developmental disorders in children in Tel Aviv]. [2006]

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

Randomized comparison of augmented and nonaugmented language interventions for toddlers with developmental delays and their parents. [2010]

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

An operant procedure for improving vocabulary definition performances in developmentally delayed children. [2019]

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

Language and cognitive development: a systematic behavioral program and technology for increasing the language and cognitive skills of developmentally disabled and at-risk preschool children. [2011]

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

Big Data in the Assessment of Pediatric Medication Safety. [2020]

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

A global approach to long-term follow-up of targeted and immune-based therapy in childhood and adolescence. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Comparison of two methods of presenting risk information to patients about the side effects of medicines. [2022]

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

Development of a Pediatric Adverse Events Terminology. [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

The Challenge of Rich Vocabulary Instruction for Children With Developmental Language Disorder. [2021]

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

Generalizing spontaneous language in developmentally delayed children via a visual cue procedure using caregivers as therapists. [2017]

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

Classification of developmental delays. [2022]