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Reciprocal Innovation to Optimize Low-Tech Augmentative and Alternative Communication (AAC) for Individuals

Reciprocal Innovation to Optimize Low-Tech Augmentative and Alternative Communication (AAC) for Individuals With Complex Communication Needs and Their Caregivers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07581483
Acronym
AAC
Enrollment
500
Registered
2026-05-12
Start date
2027-06-01
Completion date
2032-06-01
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Neurodevelopment

Keywords

Communication Needs, Neurodevelopmental Conditions, Minimally Verbal, Non-Verbal Communication

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALAutomated AAC Assessment and Low-Tech AAC Implementation Support

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.

BEHAVIORALStandard AAC Support

Communication partners receive standard of care, defined as usual AAC referral pathways and locally available AAC training and support resources.

Sponsors

Indiana University
Lead SponsorOTHER
Moi Univeristy
CollaboratorOTHER
University of Virginia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be blinded to intervention status when scoring fidelity and communication outcomes.

Intervention model description

This is a multi-site, stepped-wedge randomized trial conducted in western Kenya and rural Virginia. Communication partners are assigned to sequential intervention start times based on recruitment timing. All participants eventually receive the intervention and serve as their own controls, with outcomes compared during the waiting period prior to intervention initiation and after intervention receipt.

Eligibility

Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AAC Implementation FidelityBaseline to end of intervention (approximately 12 weeks)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.
Functional CommunicationBaseline, 6 months, and 12 monthsChange in child functional communication, measured by the Communication Matrix total score. The Communication Matrix assesses intentional communication behaviors across communication functions and modalities.

Secondary

MeasureTime frameDescription
Provider ComplianceBaseline to end of intervention (approximately 12 weeks)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.
Observed Communication BehaviorsBaseline, 6 months, and 12 monthsChange 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
Caregiver-Child Interaction QualityBaseline to end of intervention (approximately 12 weeks)Quality of interactions between communication partners and children, measured using structured observational ratings derived from video-recorded interaction samples.
Child Quality of LifeBaseline, 6 months, and 12 monthsCaregiver-reported child quality of life and participation, measured using a standardized caregiver questionnaire.
Adaptive Communication SkillsBaseline, 6 months, and 12 monthsChange in adaptive communication skills, measured using the Communication domain of the Vineland Adaptive Behavior Scales.
Provider CompetenceBaseline to end of intervention (approximately 12 weeks)Communication partner knowledge and skills related to AAC implementation, measured using a structured competency assessment.

Countries

Kenya, United States

Contacts

CONTACTAnanda Ombitsa
rananda@ampath.or.ke+254 718 748 223
CONTACTKristen Cunningham, MPH
kricunn@iu.edu317-278-5675
PRINCIPAL_INVESTIGATOREren Oyungu, MBChB

Moi University

PRINCIPAL_INVESTIGATORMegan S. McHenry, MD

Indiana University

PRINCIPAL_INVESTIGATORMandy Rispoli, PhD

University of Virginia

PRINCIPAL_INVESTIGATORJim Solan, PhD

University of Virginia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026