ClinicalTrials.gg
Not yet recruitingNCT07581483AACUpdated May 12, 2026

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

An interventional study of Automated AAC Assessment and Low-Tech AAC Implementation Support and Standard AAC Support in Autism and Neurodevelopment, sponsored by Indiana University. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Indiana University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
3 Years to 14 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Autism
  • Neurodevelopment

Keywords

  • Communication Needs
  • Neurodevelopmental Conditions
  • Minimally Verbal
  • Non-Verbal Communication
03

In context

Autistic Disorder

1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.

This study's planned enrollment of 500 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Automated AAC Assessment and Low-Tech AAC Implementation Support

  • Active comparator
    Standard AAC Support

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

    Behavioral: Standard AAC Support

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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline to end of intervention (approximately 12 weeks)

Secondary outcomes

  1. Provider Competence

    Communication partner knowledge and skills related to AAC implementation, measured using a structured competency assessment.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline, 6 months, and 12 months

Other outcomes

  1. AAC System Retention

    Proportion of children continuing to use the recommended AAC system, as reported by communication partners.

    Time frame: 6 months after intervention completion

  2. Sustainability of AAC Implementation

    Continued use of recommended AAC strategies by communication partners, assessed by caregiver report at follow-up.

    Time frame: 6 months after intervention completion

  3. AAC Use and Dosage

    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.

    Time frame: Twice weekly during the 12-week intervention period

07

Study locations

2 sites
  • University of Virginia
    Charlottesville, Virginia 22903, United States
    • Kristen Cunningham, MPH · Contactkricunn@iu.edu · 317-278-5675
    • Mandy Rispoli, PhD · Principal investigator
    • Jim Soland, PhD · Principal investigator
  • Moi Teaching and Referral Hospital
    Eldoret, Kenya
    • Ananda Ombista · Contact+254 718 748 223
    • Eren Oyungu, MBChB · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2027; primary completion for Jun 2030, 36 months later.

Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 36 months is above that.

Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2026
First posted
May 12, 2026
StartEst.
Jun 1, 2027
Primary completionEst.
Jun 1, 2030
CompletionEst.
Jun 1, 2032
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07581483
Lead sponsor
Indiana University
Collaborators
Moi Univeristy, University of Virginia
Responsible party
Megan Song McHenry (Associate Professor, Indiana University) — Principal investigator
First posted
May 12, 2026
Start date
Jun 1, 2027 (estimated)
Primary completion
Jun 1, 2030 (estimated)
Completion
Jun 1, 2032 (estimated)
Last update
May 12, 2026

Study contacts

Ananda Ombitsa
Contact
rananda@ampath.or.ke
+254 718 748 223
Kristen Cunningham, MPH
Contact
kricunn@iu.edu
317-278-5675
Eren Oyungu, MBChB
principal investigator · Moi University
Megan S. McHenry, MD
principal investigator · Indiana University
Mandy Rispoli, PhD
principal investigator · University of Virginia
Jim Solan, PhD
principal investigator · University of Virginia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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