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

NCT07581483 | Not Yet Recruiting

• 1 other identifier: AAC
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 2

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.

Conditions

Autism; Neurodevelopment

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to end of intervention (approximately 12 weeks)

Secondary Outcomes (6)

• Provider Competence

  Baseline to end of intervention (approximately 12 weeks)

• Provider Compliance

  Baseline to end of intervention (approximately 12 weeks)

• Observed Communication Behaviors

  Baseline, 6 months, and 12 months

• Caregiver-Child Interaction Quality

  Baseline to end of intervention (approximately 12 weeks)

• Adaptive Communication Skills

  Baseline, 6 months, and 12 months

Other Outcomes (3)

• AAC System Retention

  6 months after intervention completion

• Sustainability of AAC Implementation

  6 months after intervention completion

• AAC Use and Dosage

  Twice weekly during the 12-week intervention period

Study Arms (2)

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.

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.

Behavioral: Standard AAC Support

Interventions

Standard AAC Support BEHAVIORAL

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

Standard AAC Support

Automated AAC Assessment and Low-Tech AAC Implementation Support BEHAVIORAL

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.

Automated AAC Training

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Moi Univeristy: collaborator
• University of Virginia: collaborator

Study Sites (2)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

MeSH Terms

Conditions

Autistic Disorder; Nonverbal Communication

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Eren Oyungu, MBChB

  Moi University

  PRINCIPAL INVESTIGATOR

• Megan S. McHenry, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Mandy Rispoli, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Jim Solan, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ananda Ombitsa

CONTACT

+254 718 748 223; rananda@ampath.or.ke

Kristen Cunningham, MPH

CONTACT

317-278-5675; kricunn@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to intervention status when scoring fidelity and communication outcomes.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2032
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1); KE (1)