Technology-Assisted Language Intervention for Hearing Loss-related Language Delay

(TALI Trial)

Not currently recruiting at 1 trial location

Overseen By Laura Lane, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Mild hearing loss, Unilateral hearing loss, Autism, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology-assisted language tool, Technology-assisted Language Intervention (TALI), to improve language development in children who are deaf or hard of hearing. The researchers aim to determine if this technology enhances communication more effectively than standard speech therapy. Children will be randomly assigned to use this new tool alongside their usual therapy or to continue with their current therapy alone. The trial seeks children aged 3 to 10 with moderate to profound hearing loss and language challenges who are already receiving speech therapy. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could significantly enhance language development tools for children.

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 technology is safe for improving language development in children with hearing loss?

Research has shown that Technology-Assisted Language Intervention (TALI) can improve language skills in children who are deaf or hard of hearing. Although specific safety data is not available, this intervention—using software alongside regular speech-language therapy—is generally considered safe. It employs communication technology, which poses less risk than drug treatments.

Studies have not reported negative effects from using TALI. As a technology-based tool, it is likely easy for children to use without major issues. Overall, TALI appears to be a safe method to help children with hearing loss enhance their language skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Technology-Assisted Language Intervention (TALI) because it introduces a tech-savvy approach to tackling language delays due to hearing loss. Unlike traditional speech-language therapy, TALI incorporates augmentative and alternative communication software into the therapy sessions, making the intervention more interactive and engaging for children. This innovative use of technology could potentially enhance language development more effectively than the standard methods, offering a fresh, dynamic way to support kids in their communication journey.

What evidence suggests that Technology-Assisted Language Intervention (TALI) is effective for improving language development in children with hearing loss?

Studies have shown that Technology-assisted Language Intervention (TALI), one of the treatments in this trial, can effectively help children who are deaf or hard of hearing develop their language skills. One study found that children using TALI made significant progress in language, which is crucial for academic success and social interaction. Another study explained that these improvements occur because TALI incorporates visual aids and various communication methods into speech therapy. A structured 24-week program also demonstrated positive results for children with hearing difficulties. Overall, early evidence suggests that TALI is a promising tool for supporting language development in these children. Participants in this trial will receive either TALI or Treatment as Usual, which involves the child's typical speech language therapy without changes to their current care. ^{4 6 7 8 9}

Who Is on the Research Team?

Jareen Meinzen-Derr

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children aged 3-10 with moderate to profound bilateral hearing loss and a language deficit. They must be receiving speech-language therapy, have an IQ within the normal range, and speak English as their primary language. Children with mild or unilateral hearing loss, severe communication disorders like autism, nonverbal IQ below 80, or significant motor impairments cannot participate.

Inclusion Criteria

You have permanent hearing loss in both ears that is moderate to severe.

I am currently undergoing speech-language therapy.

I am between 3 and 10 years old.

Exclusion Criteria

I have slight hearing loss in one ear.

I have major difficulties with movement.

My child has a severe communication disorder, such as autism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children receive either the technology intervention or treatment as usual for language development

24 weeks

Follow-up

Participants are monitored for language development outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Technology-assisted Language Intervention (TALI)
• Treatment as usual

Trial Overview

The study compares two approaches: one uses technology-assisted language intervention tools designed for deaf or hard of hearing children; the other follows standard treatment without these tools. Kids are randomly assigned to either group to see which method better improves their language skills.

How Is the Trial Designed?

Group I: Technology Assisted Language Intervention (TALI) Active Control 1 Intervention

Augmentative and alternative communication software incorporated into active speech-language therapy

Group II: Treatment as Usual Active Control 1 Intervention

Speech language therapy child is typically receiving (no change to current care)

Technology-assisted Language Intervention (TALI) is already approved in United States for the following indications:

Approved in United States as TALI for:

• Language development in deaf or hard of hearing children

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

A study involving 180 children aged 3 to 5 years with mild-to-severe hearing loss found that better aided hearing from hearing aids is significantly associated with improved speech and language development.

The effectiveness of hearing aids was enhanced by the duration of use, indicating that longer experience with hearing aids leads to better outcomes, especially for children with the best aided hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of hearing aids on the speech and language development of children with hearing loss. Tomblin, JB., Oleson, JJ., Ambrose, SE., et al.[2022]

The paper emphasizes the importance of incorporating principles of implicit learning—variability, complexity, and sleep-dependent consolidation—into language treatment designs for children with specific language impairment (SLI) to enhance efficacy.

Current treatments often lack these principles, which are known to positively influence learning in unimpaired learners, suggesting that applying these concepts could lead to more effective interventions for children with SLI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using principles of learning to inform language therapy design for children with specific language impairment. Alt, M., Meyers, C., Ancharski, A.[2022]

The study evaluated the Language ENvironment Analysis (LENA) system as a tool for assessing early communication skills in children with cochlear implants (CIs), involving four children aged 6 to 35 months.

Results showed that LENA's measures, such as conversational turns, significantly predicted vocabulary development, suggesting it could be a valuable resource for early assessment and research on cochlear implant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Communication Abilities in Four Children with Early Bilateral CIs in Clinical and Home Environments with LENA System: A Case Report. Colombani, A., Saksida, A., Pintonello, S., et al.[2022]

Early identification and intervention for children with hearing loss, along with modern hearing technology, can help them achieve speech and language development similar to their hearing peers.

An effective early intervention system is crucial, providing families with comprehensive information and ensuring coordinated support from qualified professionals to optimize outcomes for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Assessment and Intervention: Implications for Pediatric Hearing Loss. Bobsin, LL., Houston, KT.[2015]

Augmented input, which combines verbal modeling and communication devices, showed effectiveness in improving communication skills in about two-thirds of high-quality studies, particularly when used alongside other intervention components like systematic prompting.

The effectiveness of augmented input varied based on participant characteristics such as age and receptive language skills, suggesting that tailored interventions may yield better outcomes, especially for younger individuals with strong language abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Augmented Input Interventions and Exploratory Analysis of Moderators. Chazin, KT., Ledford, JR., Pak, NS.[2023]

The Altered Auditory Input (AAI) technique modifies aspects of speech, such as rate and prosody, to help children with language delays better process language during various activities like play and reading.

Structured listening tasks called Language Webs are used to enhance language processing by providing hierarchical picture identification tasks, aiming to improve both access to existing language knowledge and the learning of new language skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered Auditory Input and Language Webs to Improve Language Processing Skills. McKinnis, S., Thompson, M.[2019]

The technology-assisted language intervention (TALI) significantly improved spoken language outcomes in children who are deaf or hard of hearing (DHH), with participants using longer phrases and more varied vocabulary compared to those receiving standard treatment over a 24-week period.

The use of visual supports in TALI helped DHH children better understand and express language, addressing persistent language delays and potentially enhancing their long-term communication skills and independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Technology-Assisted Language Intervention for Children Who Are Deaf or Hard of Hearing: A Randomized Clinical Trial. Meinzen-Derr, J., Sheldon, R., Altaye, M., et al.[2021]

Children with late-identified mild-moderate hearing loss showed significant initial language delays, particularly in phonological development, but three out of four children made rapid progress and normalized their language skills by 60 months with appropriate interventions.

Despite improvements, these children still faced challenges in specific areas such as morphosyntax and speech intelligibility, indicating that while early communication delays can resolve, there is a risk for ongoing difficulties in certain language aspects due to reduced auditory experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal development of phonology and morphology in children with late-identified mild-moderate sensorineural hearing loss. Moeller, MP., McCleary, E., Putman, C., et al.[2021]

A pilot study involving five children aged 5-10 years with permanent hearing loss showed that using the TouchChat WordPower app on iPads® significantly improved their language skills over a 24-week program, with increased mean length of utterance and vocabulary.

The children demonstrated notable growth in both the total number of words spoken and the variety of different words used, indicating that augmentative communication technology can effectively enhance language development in children who are deaf or hard-of-hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-assisted language intervention for children who are deaf or hard-of-hearing; a pilot study of augmentative and alternative communication for enhancing language development. Meinzen-Derr, J., Wiley, S., McAuley, R., et al.[2018]

Citations

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Children who are deaf and hard of hearing (DHH) often demonstrate pragmatic language difficulties which can impact academic and social outcomes.

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pubs.asha.org/doi/10.1044/2025_JSLHR-24-00589

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Linguistic intervention programs improve the language of children with hearing loss. Most of these interventions include therapies that use visual supports and ...

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Technology-assisted Language Intervention (TALI)

This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for ...

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digitalcommons.usu.edu

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Results from our recent study of TALI (Meinzen-Derr et al.,. 2016) in a 24-week structured intervention in five children with bilateral hearing loss found ...

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clinicaltrials.gov/study/NCT04857255

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This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language ...

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A Technology-Assisted Language Intervention for Children ...

The study objective was to evaluate the impact of the TALI on spoken language outcomes in DHH children. Methods: Children aged 3 to 12 years ...