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

Trial Summary

What is the purpose of this trial?

Late talkers (LT), representing 10-20% of children under 3, demonstrate hallmark syntax and vocabulary deficits similar to preschoolers with developmental language disorder. While effective and early interventions can mitigate the impact of late talking, not enough is known about its neural basis, yet is needed to inform the design of more individualized interventions. This proposed effort uses neuroimaging, along with behavioral methods, with the goal of better understanding the memory-language mechanisms that underlie learning and late talking, while also considering their association to treatment-related changes in LT.

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 for late talking?

Research shows that early language interventions, including parent-implemented strategies, can help late talkers improve their language skills. Studies found that children receiving these interventions often show better progress in speaking and understanding language compared to those who do not receive such support. ^{1 2 3 4 5}

Is the treatment for language delay safe for humans?

The research articles reviewed do not provide specific safety data for the treatment of language delay in humans. ^{2 3 4 6 7}

How is the Early Intervention for Language Delay treatment different from other treatments for late talking?

This treatment is unique because it involves a parent-implemented approach, where parents actively participate in their child's language development through activities like dialogic book reading, which has shown to improve expressive language skills in both full-term and low-risk preterm late talkers. ^{1 2 3 5 7}

Research Team

Karla N Washington, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

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)

My child was recruited for this trial through personal connections or social media.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

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

Effects in language development of young children with language delay during early intervention. [2023]

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

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

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

Systematic review of the literature on the treatment of children with late language emergence. [2018]

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

Two-Year Outcomes of a Population-Based Intervention for Preschool Language Delay: An RCT. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Parent-Implemented Language Intervention for Late Talkers: An Exploratory Study on Low-Risk Preterm and Full-Term Children. [2023]

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

Systematic review of the literature on characteristics of late-talking toddlers. [2018]

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

A Systematic Review of Interventions for Late Talkers: Intervention Approaches, Elements, and Vocabulary Outcomes. [2022]