AutismAACNCT07581483
Reciprocal Innovation to Optimize Low-Tech Augmentative and Alternative Communication (AAC) for Individuals
A study testing Automated AAC Assessment and Low-Tech AAC Implementation Support and Standard AAC Support in people with Autism and Neurodevelopment, run by Indiana University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Autism, Neurodevelopment
- What is being tested?
- Automated AAC Assessment and Low-Tech AAC Implementation Support and Standard AAC Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2027to 1 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
Kristen Cunningham, MPH, 317-278-5675, kricunn@iu.edu
Mandy Rispoli, PhD
Kenya1 site
Moi Teaching and Referral Hospital
Eldoret
Ananda Ombista, +254 718 748 223
Eren Oyungu, MBChB
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Neurodevelopment
- Being tested
- Automated AAC Assessment and Low-Tech AAC Implementation Support, Standard AAC Support
- Keywords
- Communication Needs, Neurodevelopmental Conditions, Minimally Verbal, Non-Verbal Communication
- Medical subject headings
- Autistic Disorder, Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated AAC Assessment and Low-Tech AAC Implementation SupportBehavioural
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.
Standard AAC SupportBehavioural
Communication partners receive standard of care, defined as usual AAC referral pathways and locally available AAC training and support resources.
| Study group | Role | What they receive |
|---|---|---|
| Automated AAC Training | Experimental | 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. Receives: Behavioral: Automated AAC Assessment and Low-Tech AAC Implementation Support |
| Standard AAC Support | Active comparator | Communication partners receive standard of care, defined as usual AAC referral pathways and locally available AAC training resources. Receives: Behavioral: Standard AAC Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Communication
Change in child functional communication, measured by the Communication Matrix total score. The Communication Matrix assesses intentional communication behaviors across communication functions and modalities.
Measured: Baseline, 6 months, and 12 months
AAC Implementation Fidelity
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.
Measured: Baseline to end of intervention (approximately 12 weeks)
Secondary outcomes (6)
Provider Competence
Communication partner knowledge and skills related to AAC implementation, measured using a structured competency assessment.
Measured: Baseline to end of intervention (approximately 12 weeks)
Provider Compliance
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.
Measured: Baseline to end of intervention (approximately 12 weeks)
Observed Communication Behaviors
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
Measured: Baseline, 6 months, and 12 months
Caregiver-Child Interaction Quality
Quality of interactions between communication partners and children, measured using structured observational ratings derived from video-recorded interaction samples.
Measured: Baseline to end of intervention (approximately 12 weeks)
Adaptive Communication Skills
Change in adaptive communication skills, measured using the Communication domain of the Vineland Adaptive Behavior Scales.
Measured: Baseline, 6 months, and 12 months
Child Quality of Life
Caregiver-reported child quality of life and participation, measured using a standardized caregiver questionnaire.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi Univeristy, University of Virginia
- Responsible party
- Principal investigator, Megan Song McHenry, Indiana University
- Investigators
- Eren Oyungu, MBChB, Principal investigator, Moi UniversityMegan S. McHenry, MD, Principal investigator, Indiana UniversityMandy Rispoli, PhD, Principal investigator, University of VirginiaJim Solan, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581483
- Sponsor's protocol ID
- AAC
- Acronym
- AAC
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reciprocal Innovation to Optimize Low-Tech Augmentative and Alternative Communication (AAC) for Individuals With Complex Communication Needs and Their Caregivers
- ClinicalTrials.gov ID
- NCT07581483
- Acronym / sponsor ID
- AAC / AAC
- Conditions
- Autism, Neurodevelopment
- Keywords
- Communication Needs, Neurodevelopmental Conditions, Minimally Verbal, Non-Verbal Communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Moi Univeristy, University of Virginia
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Automated AAC Training | Experimental | Behavioral: Automated AAC Assessment and Low-Tech AAC Implementation SupportCommunication 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. |
| Standard AAC Support | Active comparator | Behavioral: Standard AAC SupportCommunication partners receive standard of care, defined as usual AAC referral pathways and locally available AAC training resources. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated AAC Assessment and Low-Tech AAC Implementation SupportThis 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. | Behavioural | Automated AAC Training |
| Standard AAC SupportCommunication partners receive standard of care, defined as usual AAC referral pathways and locally available AAC training and support resources. | Behavioural | Standard AAC Support |
Primary outcome
Functional Communication
Time frame: Baseline, 6 months, and 12 months
Change in child functional communication, measured by the Communication Matrix total score. The Communication Matrix assesses intentional communication behaviors across communication functions and modalities.
AAC Implementation Fidelity
Time frame: Baseline 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.
6 secondary outcomes
Provider Competence
Time frame: Baseline to end of intervention (approximately 12 weeks)
Provider Compliance
Time frame: Baseline to end of intervention (approximately 12 weeks)
Observed Communication Behaviors
Time frame: Baseline, 6 months, and 12 months
Caregiver-Child Interaction Quality
Time frame: Baseline to end of intervention (approximately 12 weeks)
Adaptive Communication Skills
Time frame: Baseline, 6 months, and 12 months
Child Quality of Life
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Related trials for Autism
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eren Oyungu, MBChB principal investigator
Moi University
Megan S. McHenry, MD principal investigator
Indiana University
Mandy Rispoli, PhD principal investigator
University of Virginia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated AAC Assessment and Low-Tech AAC Implementation Support and Standard AAC Support in people with Autism and Neurodevelopment, run by Indiana University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ananda Ombitsa (+254 718 748 223, rananda@ampath.or.ke), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Communication (time frame: Baseline, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.