Early Intervention for Language Delay

Recruiting at 1 trial location

Overseen By Nicole Bazzocchi, MhSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Not LT, MRI criteria, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 to 8 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to assist young children who are late talkers by examining how their brains function during language learning. Children in the trial will either receive immediate intervention to address late talking or receive help later. Researchers will use special brain scans and activities to observe changes in language learning over time. Children between 18 and 30 months old, who primarily speak English and are enrolled at specific locations, may be suitable candidates for this trial. As an unphased trial, it offers parents a unique opportunity to contribute to groundbreaking research that could enhance their child's language development.

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 intervention is safe for children with language delay?

Research has shown that programs designed to help late talkers, such as those teaching parents how to support their child's language skills, are generally safe and well-received. These programs primarily instruct parents on methods to aid their child's language development. They have been successfully used to manage language delays without significant safety concerns.

While detailed safety data from clinical trials may not be available, these programs focus on guidance and activities rather than medicine or medical procedures, indicating a low risk of issues. The emphasis is on improving grammar, vocabulary, and communication through structured support, which is unlikely to cause harm.

For those considering joining a trial, this type of program focuses on learning and support, making it a generally safe choice for children and parents. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this early intervention for language delay because it takes a unique two-pronged approach. Unlike traditional speech therapy, which often focuses solely on direct interaction with the child, this treatment actively involves parents through adult learning to enhance their ability to support their child's language development. By combining parental education with direct support for late-talking children, the intervention aims to improve grammar, vocabulary, and functional communication in just 6 to 8 weeks. This holistic method could potentially lead to faster and more sustainable improvements than current options, making it a promising new path for helping children with language delays.

What evidence suggests that this trial's treatments could be effective for late talking?

This trial will compare an intervention program for late talking with a waitlist control group. Research has shown that assisting children who begin talking later than usual can be very effective. One study found that speech and language therapy significantly improves vocabulary in these children. Another study confirmed that parental involvement also boosts language development in late talkers. These methods focus on enhancing grammar, vocabulary, and everyday communication. While many late talkers eventually catch up independently, early intervention can accelerate progress and reduce language difficulties. ^{6 7 8 9 10}

Who Is on the Research Team?

Karla N Washington, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for children aged 18-30 months who are late talkers and primarily English-speaking without vision issues. They must be enrolled at a participating facility, have no MRI contraindications like metal implants or claustrophobia, and not be in special education due to ability or behavior.

Inclusion Criteria

Child does not have any uncorrected vision challenges

Child does not have any contraindications to magnetic resonance imaging (i.e., intracranial metal implants, claustrophobia)

Child is enrolled at one of the participating facilities

Exclusion Criteria

Standard magnetic resonance imaging exclusion criteria

Child does not meet criteria for LT or typical development

Gestational age less than 37 weeks or greater than 42 weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive an intervention program addressing late talking, including parent coaching and direct therapy for children, over 6 to 8 weeks.

6 to 8 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for treatment-related changes in language function and structural connectivity.

8 to 9 weeks

3 visits (in-person)

Open-label extension (optional)

Participants may continue to receive intervention after the main study period.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Intervention to address late talking

Trial Overview

The study aims to understand the brain and behavioral aspects of late talking in toddlers using neuroimaging techniques and behavioral assessments. It seeks to identify memory-language mechanisms that could inform tailored interventions for language development disorders.

How Is the Trial Designed?

Group I: Intervention to address late talking Experimental Treatment 1 Intervention

half the participants receive an intervention program addressing late talking. The intervention is comprised of adult learning (to teach parents) and direct support for children who are late talkers. The intervention occurs over 6 to 8 weeks and is designed to improve grammar, vocabulary, and functional communication

Group II: Waitlist controls Active Control 1 Intervention

half the participants are waitlist controls who receive intervention at a later date, after the study has ended

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Holland Bloorview Kids Rehabilitation Hospital

Collaborator

Trials

69

Recruited

14,100+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Published Research Related to This Trial

Interventions for children aged 24-36 months with late language emergence showed significant improvements in language skills, with medium to large effect sizes reported in good-quality studies involving 275 participants.

Focused stimulation and modeling of single words were particularly effective treatment strategies, suggesting that targeted approaches can enhance language development in late talkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the literature on the treatment of children with late language emergence. Cable, AL., Domsch, C.[2018]

A parent-implemented dialogic book reading intervention significantly improved expressive language skills in 31-month-old late talkers, with more children in the intervention group recovering from their language delays compared to the control group.

Both low-risk preterm and full-term children benefited from the intervention, with notable increases in the production of complete sentences and overall vocabulary growth, suggesting this approach is effective and cost-efficient for enhancing language development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parent-Implemented Language Intervention for Late Talkers: An Exploratory Study on Low-Risk Preterm and Full-Term Children. Zuccarini, M., Suttora, C., Bello, A., et al.[2023]

Late talking in toddlers can lead to significant long-term impacts on socialization and school readiness, highlighting the need for early intervention rather than a wait-and-see approach.

Parent-implemented interventions can effectively address the risks associated with late talking and enhance protective factors, utilizing existing interprofessional practice frameworks in early intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late Talkers: Why the Wait-and-See Approach Is Outdated. Capone Singleton, N.[2022]

A randomized trial involving 200 children with language delays at age 4 showed that while mean language scores normalized by age 6, there was no significant treatment effect on receptive or expressive language skills after the intervention.

The intervention did improve phonological awareness skills, but it came at a high cost, with intervention families spending an average of AU$4276 more than control families, suggesting that while the program was feasible, its long-term benefits must be carefully considered against its expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Year Outcomes of a Population-Based Intervention for Preschool Language Delay: An RCT. Wake, M., Levickis, P., Tobin, S., et al.[2015]

Late-talking toddlers are at a higher risk for ongoing language-learning difficulties, making early intervention crucial for their development.

The review emphasizes the need for a broader understanding of language delays in these children, suggesting that factors like social-emotional development and family language stimulation play significant roles beyond just vocabulary delays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the literature on characteristics of late-talking toddlers. Desmarais, C., Sylvestre, A., Meyer, F., et al.[2018]

A systematic review of 34 intervention studies involving 1,207 late talkers (ages 18 to 42 months) found that all intervention approaches (direct, indirect, and hybrid) led to improvements in expressive vocabulary in 93% of the studies.

Indirect and hybrid approaches included parent training, which may enhance the effectiveness of interventions, while direct approaches did not, highlighting the importance of considering the type of intervention when selecting strategies for individual children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Interventions for Late Talkers: Intervention Approaches, Elements, and Vocabulary Outcomes. Carson, L., Baker, E., Munro, N.[2022]

A study involving 183 children with Language Delay showed that both younger (< 3 years) and older (≥ 3 years) children made significant improvements in receptive and expressive language skills during early language intervention.

Younger children demonstrated greater progress in all language domains compared to older children, suggesting that earlier intervention may be more beneficial, although the reasons for this difference remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects in language development of young children with language delay during early intervention. Vermeij, BAM., Wiefferink, CH., Knoors, H., et al.[2023]

Citations

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Late Language Emergence

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