AAC Technology for Child Hearing Loss

Not currently recruiting at 1 trial location

Overseen By Jareen Meinzen-Derr, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Nonverbal IQ <60, Autism, others

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

Approved in 3 Jurisdictions 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 aims to evaluate how well augmentative and alternative communication (AAC) technology aids language development in children who are deaf or hard of hearing. Some children will use AAC technology alongside their regular speech and language therapy, while others will continue with their usual care. Suitable candidates have permanent hearing loss, a language gap, and are already receiving speech-language therapy. The goal is to determine if this technology significantly improves their language skills. As an unphased trial, this study provides a unique opportunity for participants to contribute to pioneering research that could enhance language development strategies for children with hearing loss.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 AAC technology is safe for enhancing language development in children who are deaf or hard of hearing?

Research shows that augmentative and alternative communication (AAC) technology is generally safe for children. This includes tools like tablet software that assist in communication. Studies have found that children with hearing loss tolerate AAC well, with no reports of serious side effects from these aids.

AAC tools often support language development in children with various communication needs. While children might need time to adapt to the technology, evidence supports its safety. The study is in the "not applicable" phase, focusing on understanding AAC's effectiveness rather than proving its safety. This typically indicates that the technology is already considered safe based on past experiences or approvals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AAC Technology for child hearing loss because it introduces a fresh approach by integrating augmentative and alternative communication software into speech-language therapy using iPads. Unlike traditional therapies that typically rely on verbal and auditory methods, this technology-assisted intervention provides a visual and interactive platform, which can be especially beneficial for children who struggle with conventional communication methods. This innovative use of technology aims to enhance engagement and improve communication skills, offering a potentially more effective and engaging way to support children with hearing loss.

What evidence suggests that AAC technology is effective for enhancing language development in children with hearing loss?

Research has shown that augmentative and alternative communication (AAC) technology can improve language skills in children who are deaf or hard of hearing. AAC includes tools like speech-generating devices and touchscreen programs, which facilitate communication. In this trial, one group of participants will receive technology-assisted language intervention, incorporating AAC software delivered on iPads into speech-language therapy. Studies have found that children using AAC tools, such as the Picture Exchange Communication System (PECS), often develop better communication skills. Early results suggest that incorporating AAC in speech therapy can enhance language development more effectively than traditional methods alone. This technology complements regular therapies, providing children with additional ways to express themselves and connect with others. ^{2 6 7 8 9}

Who Is on the Research Team?

Jareen Meinzen-Derr, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children with a language gap and documented permanent bilateral hearing loss of any severity who are already receiving speech-language therapy. It excludes those whose primary language isn't English, have significant motor impairments, nonverbal IQ below 60, or severe communication disorders like autism.

Inclusion Criteria

Identified with a language gap

I am currently undergoing speech-language therapy.

I have permanent hearing loss in both ears.

Exclusion Criteria

Primary language other than English

My child has a severe communication disorder like autism.

I have major difficulties with movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AAC technology with speech-language therapy or continue with usual care

24 weeks

Follow-up

Participants are monitored for language development outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AAC Technology
• Usual Care

Trial Overview The study tests if using augmentative and alternative communication (AAC) technology can improve language development in deaf or hard-of-hearing children. Participants will either receive AAC tech alongside their usual speech therapy or continue with their current care without the tech.

How Is the Trial Designed?

Group I: Technology-assisted language intervention Experimental Treatment 1 Intervention

This intervention will incorporate augmentative and alternative communication software delivered on iPads into speech-language therapy

Group II: usual care Active Control 1 Intervention

This group will be usual care children are already receiving.

AAC Technology is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as AAC Technology for:

• Language development in children who are deaf or hard of hearing

Approved in United States as AAC Technology for:

• Language development in children who are deaf or hard of hearing
• Communication assistance for individuals with autism, cerebral palsy, and other speech disorders

Approved in Canada as AAC Technology for:

• Language development in children who are deaf or hard of hearing
• Communication assistance for individuals with speech disorders

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Published Research Related to This Trial

In a survey of 150 parents of children on anticonvulsant treatment, 63.3% expressed fears about adverse drug events (ADE), particularly concerning serious issues like liver injury, while 86% reported experiencing less severe ADE such as sedation and abnormal behavior.

Despite the fears of life-threatening ADE, the actual experienced ADE had significant negative impacts on the children's daily lives and development, highlighting a gap between parental concerns and the realities of treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do parents perceive adverse drug events of their children's anticonvulsant medication? Bach, VA., Neininger, MP., Spindler, UP., et al.[2018]

In a study of 740 patients in a pediatric intensive care unit (PICU), systematic enquiry identified 80% of adverse events, including serious ones, while voluntary reporting mainly captured insignificant and minor events, highlighting the limitations of each method.

A total of 524 adverse events were recorded, with systematic enquiry detecting 405 events and voluntary reporting only capturing 166, indicating that relying solely on voluntary reporting may miss critical incidents in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit. Silas, R., Tibballs, J.[2010]

A total of 240 adverse drug reaction (ADR) reports were analyzed from children in Europe, revealing that the majority of reports came from infants under 1 year and teenage girls, highlighting a significant concern for drug safety in these age groups.

Serious ADRs were predominantly related to nervous system disorders, and vaccines and anti-infectives accounted for a significant portion of the reports, indicating the need for careful monitoring of these medications in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in children reported by European consumers from 2007 to 2011. Aagaard, L., Hansen, EH.[2021]

A systematic review of 14 randomized controlled trials involving 666 children found that Augmentative and Alternative Communication (AAC) interventions are effective for children with severe speech and language disorders.

The study highlights the need for more diverse research methods beyond just randomized controlled trials to generate solid evidence on the positive effects of AAC, and emphasizes the importance of integrating this knowledge into the broader medical community for better clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of interventions to supplement spoken communication for children with limited speech or language skills. Costantino, MA., Bonati, M.[2021]

AAC technologies can significantly enhance communication for young children with complex communication needs, providing them with essential tools for language and literacy development.

The paper emphasizes the need for ongoing research to improve AAC technologies and interventions, aiming to maximize the developmental potential of these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAC technologies for young children with complex communication needs: state of the science and future research directions. Light, J., Drager, K.[2022]

AAC technology is crucial for individuals with significant communication disorders, helping to improve their quality of life by optimizing communication despite motor limitations.

Innovations in AAC components can enhance language performance, which is essential in the matching process of individuals to appropriate communication technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in augmentative and alternative communication as quality-of-life technology. Hill, K.[2009]

A total of 78,623 adverse event reports were analyzed from the FDA database, with serious outcomes occurring in 40% of children and 43% of adolescents, highlighting the significant risk associated with medications in these age groups.

Central nervous system stimulants and analgesics were the most commonly reported drugs in children, while adolescents reported more cases involving tumor necrosis factor blockers and atypical antipsychotics, indicating different medication safety profiles and adverse event types based on age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs associated with adverse events in children and adolescents. Lee, WJ., Lee, TA., Pickard, AS., et al.[2014]

The study identified 23 existing outcome measures used in Augmentative and Alternative Communication (AAC) services, but none adequately cover the comprehensive objectives of AAC provision, highlighting a gap in current assessment methods.

To address this gap, the AAC Therapy Outcome Measure (AAC TOM) was developed, incorporating principles from the International Classification of Functioning (ICF-WHO) and is currently being trialed in UK AAC services to better reflect the impact of service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing the therapy outcome measure for AAC services in the context of a review of other measures. Enderby, P.[2019]

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

A scoping review of 29 studies involving 378 pediatric cochlear implant recipients with additional disabilities highlighted the potential of augmentative and alternative communication (AAC) to support language development in this population.

Despite the promising role of AAC, particularly high-tech options, there is a notable gap in research specifically focusing on their implementation and effectiveness in pediatric cochlear implant users, indicating a need for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmentative and alternative communication (AAC) in pediatric cochlear implant recipients with complex needs: A scoping review. Richlin, BC., Chow, K., Cosetti, MK.[2023]

Augmentative and alternative communication (AAC) methods have significantly advanced in the last decade, improving support for children with developmental and intellectual disabilities who have limited speech.

The article highlights the importance of empirical research and technological innovations in enhancing AAC, while also identifying key issues and future growth areas in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of research and practice in augmentative and alternative communication for children with developmental/intellectual disabilities. Wilkinson, KM., Hennig, S.[2022]

In a study of 35 children with severe motor disorders, augmentative communication systems were provided, with 18 symbol systems and 7 speech output devices being used for communication after 15-18 months.

Successful outcomes in using these aids were linked to factors such as receiving the equipment early, having adequate training, and the child being older than 6 years at the time of assessment, highlighting the need for better professional guidance and planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of recommendations for augmentative communication in children. Ko, ML., McConachie, H., Jolleff, N.[2019]

A meta-analysis of 19 studies involving 66 young children with complex communication needs found that speech-generating devices (SGDs) and picture exchange systems were equally effective for teaching children to request in structured settings.

Children showed a preference for SGDs over manual sign language, indicating that while both AAC methods can be effective, SGDs may enhance the learning experience for some children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Interventions With Speech-Generating Devices and Other Augmentative and Alternative Communication Modes: A Meta-Analysis. Pak, NS., Bailey, KM., Ledford, JR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7891685/

A Technology-Assisted Language Intervention for Children ... Audiograms and audiologic histories, including hearing-device use (hearing aids and cochlear implants), were reviewed from medical records. Language ...

2. asha.org asha.org/practice-portal/professional-issues/augmentative-and-alternative-communication/?srsltid=AfmBOorxrAJ9IAeb_LT6KfDbbf322DWJugbT7BAmIpHpOdqy5q_HFB7j

Augmentative and Alternative Communication (AAC) A survey of U.K. service providers conducted by Judge et al. (2017) reported an average of 0.0155% of individuals known to be using powered communication aids ( ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587623001775

Augmentative and alternative communication (AAC) in ... High-tech AAC typically utilizes electronic devices while low-tech AAC incorporates non-electronically powered physical aids [6]. Recent studies have ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8009928/

Augmentative and Alternative Communication for Children ... ... communication aids. Language, Speech & Hearing Services in Schools ... augmentative and alternative communication (AAC) outcomes for children with ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587619302897

Enhancing language in children who are deaf/hard-of- ... ... AAC included a Picture Exchange Communication System (PECS), Voice Output Communication Aids (VOCA), and touchscreen programs such as TouchChat® HD. Various ...

6. apps.asha.org apps.asha.org/EvidenceMaps/Maps/LandingPage/990772a6-9cd8-4203-a76c-6ccd91eac874

Augmentative and Alternative Communication (AAC) ... hearing aids and hearing aid technologies for individuals with a hearing loss. Another section discusses the effectiveness of assistive ...

7. publications.aap.org publications.aap.org/pediatrics/article/156/1/e2025072216/202154/Prescribing-Assistive-Technology-Focus-on-Children

Prescribing Assistive Technology: Focus on Children With ... Table 1 describes examples of the variety of AAC currently available. Low-tech strategies describe aids that do not require the use of batteries ...

8. mdpi.com mdpi.com/2227-7102/15/2/170

Assistive Technology and Alternative and Augmentative ... AAC refers not only to aided and unaided systems of communication, but also to various strategies and techniques that use symbols and low- and high-tech aids to ...

9. nasenjournals.onlinelibrary.wiley.com nasenjournals.onlinelibrary.wiley.com/doi/full/10.1111/1471-3802.12680

The research status of augmentative and alternative ... The above data show that in the existing studies, AAC intervention tools mainly focus on applying low-technology communication aids (such as ...