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

(TALI Trial)

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

114 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual

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 Technology-Assisted Language Intervention (TALI) for hearing loss-related language delay?

Research shows that the Technology-Assisted Language Intervention (TALI) helps improve spoken language outcomes in children who are deaf or hard of hearing by using communication technology in speech-language therapy. This approach supports language learning and can help children with hearing loss achieve language milestones similar to their hearing peers. ^{1 2 3 4 5}

Is Technology-Assisted Language Intervention (TALI) safe for humans?

The available research does not specifically address the safety of Technology-Assisted Language Intervention (TALI) in humans, but it focuses on its use for language development in children who are deaf or hard of hearing. ^{1 3 6 7 8}

How is the Technology-Assisted Language Intervention (TALI) treatment different from other treatments for language delay related to hearing loss?

TALI is unique because it uses augmentative and alternative communication technology to support language learning in children who are deaf or hard of hearing, integrating this technology into a speech-language therapy model, which is different from traditional methods like hearing aids that focus on improving hearing ability. ^{1 2 3 5 9}

Research Team

Jareen Meinzen-Derr

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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.

Primary language other than English

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

A Technology-Assisted Language Intervention for Children Who Are Deaf or Hard of Hearing: A Randomized Clinical Trial. [2021]

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

Communication Assessment and Intervention: Implications for Pediatric Hearing Loss. [2015]

3. England 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. [2018]

4. Switzerland 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. [2022]

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

The influence of hearing aids on the speech and language development of children with hearing loss. [2022]

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

Using principles of learning to inform language therapy design for children with specific language impairment. [2022]

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

A Systematic Review of Augmented Input Interventions and Exploratory Analysis of Moderators. [2023]

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

Altered Auditory Input and Language Webs to Improve Language Processing Skills. [2019]

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

Longitudinal development of phonology and morphology in children with late-identified mild-moderate sensorineural hearing loss. [2021]