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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Kristen Cunningham, MPH contact

317-278-5675

kricunn@iu.edu

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

Other trials in United States

Kenya1 site
  • Moi Teaching and Referral Hospital

    Eldoret

    Ananda Ombista, +254 718 748 223

    Eren Oyungu, MBChB

Other trials in Kenya

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.

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 groups in NCT07581483
Study groupRoleWhat they receive
Automated AAC TrainingExperimentalCommunication 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 SupportActive comparatorCommunication 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.

  1. 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

  2. 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)
  1. 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)

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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.

  1. First posted12 May 2026
  2. Study start1 Jun 2027 (estimated)
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2032 (estimated)

Resources

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)
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

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.

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