AAC Technology for Child Hearing Loss

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

154 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.

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 data supports the idea that AAC Technology for Child Hearing Loss is an effective treatment?

The available research shows that AAC Technology can significantly improve communication skills for children with complex communication needs. For example, one study found that children who received AAC devices, like symbol systems and speech output devices, were able to use them for communication, with some using them frequently. Factors such as early access to the devices and proper training contributed to better outcomes. Additionally, AAC Technology has been shown to enhance the quality of life for individuals with communication disorders by optimizing their ability to communicate. Compared to other communication modes, AAC systems, including speech-generating devices, have been effective in helping children acquire communication skills. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment AAC Technology for Child Hearing Loss?

Research shows that AAC technology can improve communication, language, and literacy skills in children with complex communication needs, enhancing their quality of life. Studies also indicate that early access to AAC devices and proper training can lead to more successful communication outcomes. ^{1 2 3 4 5}

What safety data exists for AAC Technology in treating child hearing loss?

The provided research does not specifically address the safety data for AAC Technology or related communication aids in treating child hearing loss. The studies focus on adverse events related to medications and general pediatric care, not on AAC devices. Therefore, specific safety data for AAC Technology in this context is not available in the given research. ^{6 7 8 9 10}

Is AAC Technology a promising treatment for child hearing loss?

Yes, AAC Technology is a promising treatment for child hearing loss. It helps children with complex communication needs by providing tools to improve their communication, language, and literacy skills. This technology has evolved rapidly, offering better ways for children to express themselves and reach their full potential. ^{1 4 11 12 13}

How is AAC Technology different from other treatments for child hearing loss?

AAC Technology is unique because it provides children with complex communication needs access to communication through devices and methods that supplement or replace spoken language, unlike traditional treatments that focus on improving hearing or speech directly. This technology is particularly beneficial for children with additional disabilities, as it offers alternative ways to develop communication, language, and literacy skills. ^{1 4 11 12 13}

Research Team

Jareen Meinzen-Derr, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

Comparing Interventions With Speech-Generating Devices and Other Augmentative and Alternative Communication Modes: A Meta-Analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Outcome of recommendations for augmentative communication in children. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

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

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

6. Spain pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. [2012]

7. England pubmed.ncbi.nlm.nih.gov

How do parents perceive adverse drug events of their children's anticonvulsant medication? [2018]

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

Drugs associated with adverse events in children and adolescents. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit. [2010]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in children reported by European consumers from 2007 to 2011. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

Augmentative and alternative communication (AAC) in pediatric cochlear implant recipients with complex needs: A scoping review. [2023]

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

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

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

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