- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07581483
Reciprocal Innovation to Optimize Low-Tech Augmentative and Alternative Communication (AAC) for Individuals (AAC)
Reciprocal Innovation to Optimize Low-Tech Augmentative and Alternative Communication (AAC) for Individuals With Complex Communication Needs and Their Caregivers
Many people with autism and other developmental conditions have difficulty speaking or do not use speech and need other ways to communicate. Augmentative and alternative communication (AAC) includes tools such as picture boards, communication books, and gestures that support communication. In low-resource settings and underserved rural areas in the United States, high-tech AAC devices are often too expensive or difficult to access, and trained specialists are limited.
Low-tech AAC options are more affordable but are often not used successfully because tools may not match the individual's abilities or daily environment, caregivers and providers may lack training, and stigma or low awareness may discourage use. These challenges can lead to AAC abandonment and social isolation.
Rural Virginia and western Kenya face similar barriers, including limited AAC expertise, inconsistent assessment, and insufficient training for families, educators, and community providers. This project uses a shared learning approach that combines western Kenya's experience implementing low-tech AAC in new settings with rural Virginia's expertise in individualized assessment, training, and scalable service delivery. The goal is to better match individuals to appropriate low-tech AAC systems and support communication partners to use them effectively.
Przegląd badań
Status
Warunki
Szczegółowy opis
Many people with autism and related developmental conditions have difficulty speaking or do not use speech at all. These individuals often benefit from augmentative and alternative communication (AAC), which includes tools such as picture boards, communication books, object symbols, and structured communication routines. AAC helps people express needs, make choices, and engage socially.
In low-resource countries and underserved rural areas of the United States, high-tech AAC devices are often not available. These systems can be expensive, require reliable electricity or internet access, and depend on trained specialists who may not be available locally. As a result, families and providers frequently rely on low-tech AAC options, which are more affordable and practical in these settings.
However, low-tech AAC is often not used effectively. Common barriers include stigma around disability, limited awareness of AAC, lack of access to appropriate materials, and poor matching between the communication system, the individual's abilities, and their everyday communication environment. Inconsistent assessment practices and limited training for caregivers, teachers, and other communication partners further reduce successful use. These challenges often lead to AAC being abandoned, leaving individuals socially isolated and unable to communicate effectively.
Rural Virginia and western Kenya face many of the same challenges. In both locations, access to AAC specialists is limited, individualized assessments are inconsistent, and communication partners often receive little or no formal training. Addressing these gaps requires approaches that are scalable, affordable, and culturally responsive. Effective solutions must systematically assess individual abilities and environments, guide selection of appropriate low-tech AAC systems, and support communication partners in using these systems consistently and correctly.
This project uses a reciprocal innovation approach, in which both regions contribute expertise. Western Kenya offers experience in implementing low-tech communication systems in communities that are new to AAC, while rural Virginia contributes experience with individualized assessment, provider training, and scalable technology-based tools. By combining strengths from both settings, the project aims to create solutions that work across diverse contexts.
The overall goal of this study is to develop, validate, and test an automated AAC assessment and implementation system for minimally verbal or non-speaking individuals. This system is designed to improve how well AAC tools match users' abilities and environments and to improve everyday communication outcomes. The project is based on the idea that combining an adaptive computer-based assessment with culturally appropriate low-tech AAC materials and automated training for communication partners will lead to better AAC selection, more consistent use, and lasting improvements in functional communication and participation.
Aim 1 focuses on developing and validating an open-access, computer-based AAC assessment. This assessment will adapt to the individual being assessed and gather information about motor, sensory, cognitive, language, and environmental factors that affect communication. Based on these responses, the tool will generate personalized recommendations for low-tech AAC systems. The study will examine whether the assessment is reliable, valid, works similarly across cultures, and produces recommendations that align with expert clinician judgments in both western Kenya and rural Virginia.
Aim 2 focuses on adapting and standardizing low-tech AAC materials for use across cultures. Using information from the assessment, the research team will develop and adapt AAC tools such as picture boards, object-based symbols, and structured communication routines to ensure they fit local languages, cultures, and daily environments. These materials will be tested and refined with individuals who use AAC and their communication partners to ensure they are easy to use, acceptable, and meaningful in both settings.
Aim 3 consists of a multi-site, parallel-group randomized controlled trial conducted in western Kenya and rural Virginia. Communication partners, including caregivers, teachers, community health workers, and aides, will be randomized to receive either an automated AAC training toolkit or standard AAC support available in their community. The primary outcomes assess implementation outcomes, including communication partner competence, compliance, and fidelity in the use of AAC strategies. Secondary outcomes assess child functional communication, caregiver-child interaction quality, and quality of life. Sustainability of AAC implementation and AAC system retention will be assessed at six-month follow-up.
Overall, this project will produce a tested, open-access AAC assessment and implementation system that reduces reliance on scarce specialists, improves matching between individuals and communication systems, and strengthens communication outcomes. By combining automated assessment, culturally adapted low-tech AAC materials, and scalable training within a reciprocal innovation framework, this research will support more equitable access to effective AAC in both global low-resource settings and underserved rural communities in the United States.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ananda Ombitsa
- Numer telefonu: +254 718 748 223
- E-mail: rananda@ampath.or.ke
Kopia zapasowa kontaktu do badania
- Nazwa: Kristen Cunningham, MPH
- Numer telefonu: 317-278-5675
- E-mail: kricunn@iu.edu
Lokalizacje studiów
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Eldoret, Kenia
- Moi Teaching and Referral Hospital
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Kontakt:
- Ananda Ombista
- Numer telefonu: +254 718 748 223
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Główny śledczy:
- Eren Oyungu, MBChB
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Virginia
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Charlottesville, Virginia, Stany Zjednoczone, 22903
- University of Virginia
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Kontakt:
- Kristen Cunningham, MPH
- Numer telefonu: 317-278-5675
- E-mail: kricunn@iu.edu
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Główny śledczy:
- Mandy Rispoli, PhD
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Główny śledczy:
- Jim Soland, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Communication partners (e.g., caregivers, parents, teachers, community health workers, or aides) aged 18 years or older
- Primary communication partner of a child aged 3 to 14 years
- Child has a documented diagnosis of autism spectrum disorder or a related neurodevelopmental condition
- Child is minimally verbal or non-verbal
- Able to communicate in English (U.S. sites) or English or Swahili (Kenya sites)
- Able and willing to provide informed consent
Exclusion Criteria:
- Communication partners younger than 18 years of age
- Communication partners of children younger than 3 years or older than 14 years
- Communication partners of children who use fluent spoken language
- Inability to communicate in the required study languages
- Inability or unwillingness to provide informed consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Automated AAC Training
Communication partners receive access to an automated AAC system-matching assessment and an automated training toolkit designed to support implementation of personalized low-tech AAC strategies in daily routines.
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This intervention includes a computer-based assessment that identifies individual communication needs and generates personalized recommendations for low-tech augmentative and alternative communication (AAC) strategies.
Recommended AAC materials, such as picture-based boards, object symbols, and communication routines, are culturally adapted for use in western Kenya and rural Virginia.
Communication partners use these recommendations to support consistent and appropriate AAC use in daily activities.
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Aktywny komparator: Standard AAC Support
Communication partners receive standard of care, defined as usual AAC referral pathways and locally available AAC training resources.
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Communication partners receive standard of care, defined as usual AAC referral pathways and locally available AAC training and support resources.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Functional Communication
Ramy czasowe: Baseline, 6 months, and 12 months
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Change in child functional communication, measured by the Communication Matrix total score.
The Communication Matrix assesses intentional communication behaviors across communication functions and modalities.
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Baseline, 6 months, and 12 months
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AAC Implementation Fidelity
Ramy czasowe: Baseline to end of intervention (approximately 12 weeks)
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Fidelity of augmentative and alternative communication (AAC) implementation by communication partners, measured using a standardized AAC fidelity checklist based on recommended system use and communication strategies.
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Baseline to end of intervention (approximately 12 weeks)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Provider Competence
Ramy czasowe: Baseline to end of intervention (approximately 12 weeks)
|
Communication partner knowledge and skills related to AAC implementation, measured using a structured competency assessment.
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Baseline to end of intervention (approximately 12 weeks)
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Provider Compliance
Ramy czasowe: Baseline to end of intervention (approximately 12 weeks)
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Adherence to recommended AAC strategies during daily routines, measured as the proportion of recommended AAC strategies implemented, based on caregiver-reported use across daily activities.
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Baseline to end of intervention (approximately 12 weeks)
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Observed Communication Behaviors
Ramy czasowe: Baseline, 6 months, and 12 months
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Change in observed child communication behaviors, measured using video-recorded communication samples coded with the Communication Complexity Scale (CCS) for a randomly selected subset of participants
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Baseline, 6 months, and 12 months
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Caregiver-Child Interaction Quality
Ramy czasowe: Baseline to end of intervention (approximately 12 weeks)
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Quality of interactions between communication partners and children, measured using structured observational ratings derived from video-recorded interaction samples.
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Baseline to end of intervention (approximately 12 weeks)
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Adaptive Communication Skills
Ramy czasowe: Baseline, 6 months, and 12 months
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Change in adaptive communication skills, measured using the Communication domain of the Vineland Adaptive Behavior Scales.
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Baseline, 6 months, and 12 months
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Child Quality of Life
Ramy czasowe: Baseline, 6 months, and 12 months
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Caregiver-reported child quality of life and participation, measured using a standardized caregiver questionnaire.
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Baseline, 6 months, and 12 months
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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AAC System Retention
Ramy czasowe: 6 months after intervention completion
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Proportion of children continuing to use the recommended AAC system, as reported by communication partners.
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6 months after intervention completion
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Sustainability of AAC Implementation
Ramy czasowe: 6 months after intervention completion
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Continued use of recommended AAC strategies by communication partners, assessed by caregiver report at follow-up.
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6 months after intervention completion
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AAC Use and Dosage
Ramy czasowe: Twice weekly during the 12-week intervention period
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Frequency of AAC use, caregiver implementation dosage, and availability of AAC systems during daily routines, measured using ecological momentary assessment (EMA) delivered via smartphone application.
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Twice weekly during the 12-week intervention period
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Eren Oyungu, MBChB, Moi University
- Główny śledczy: Megan S. McHenry, MD, Indiana University
- Główny śledczy: Mandy Rispoli, PhD, University of Virginia
- Główny śledczy: Jim Solan, PhD, University of Virginia
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AAC
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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