Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners

NCT07384156 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 251267
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether adding Integrated Decoding and Encoding instruction to the ALLSTAR literacy program improves reading outcomes for students with significant literacy and communication needs. The study will also examine how students' reading skills change over time across instructional conditions. The main questions it aims to answer are: Do students who receive ALLSTAR with Integrated Decoding and Encoding instruction demonstrate greater improvements in literacy outcomes than students who receive ALLSTAR as standard care alone? How do students' literacy skills change from baseline to mid-intervention and post-intervention across the two instructional conditions? Researchers will compare two groups using a randomized controlled trial design. One group will receive 60 lessons of ALLSTAR as the standard of care (ALLSTAR-SC), and the other group will receive 60 lessons of ALLSTAR with the addition of Integrated Decoding and Encoding lessons (ALLSTAR-I\*). Literacy outcomes will be measured using repeated assessment probes at baseline (0 Lessons), after 30-40 lessons, and after 60 lessons to evaluate differences between groups and changes over time in the individuals.

Conditions

Literacy; Communication, Nonverbal

Keywords

literacy; augmentative and alternative communication; nonverbal; Communication; Autism; Intellectual Disabilities

Outcome Measures

Primary Outcomes (1)

• Percent correct on Early Literacy Assessment (ELA)

  Early Literacy Assessment (ELA) is a 120 question measure that covers six literacy skills. It was specifically created for a population with minimal or no speech. The ELA will be used to assess progress in domains of: letter-sound correspondence, sound blending, decoding, grapheme-phoneme typing, and encoding.

  At study completion of the required 60 lessons, an average of 5 months

Secondary Outcomes (1)

• The difference between the two literacy interventions for individuals who have minimal or no speech

  After study completion, an average of 5 months

Other Outcomes (1)

• Qualitative Analysis of Service Provider's Social Validity of the two literacy interventions

  Three times through the course of the study, on average at 0, 10, and 20 weeks.

Study Arms (2)

ALLSTAR-SC

ACTIVE COMPARATOR

The ALL app comes with lessons in early literacy skills, with the materials are pre-made, and tasks are modified to support independent participation by AAC users. By using ALLSTAR as "Standard of Care", the evidence base has the potential to increase by demonstrating related to demonstration that AAC users can learn multiple skills and when provided the opportunity to learn phonics. Intervention with the app includes 50 trials per lesson and an instructional sequence that service providers are trained to implement, including: introducing the skill, two model trials, five trials using guided practice techniques, and three trials of independent practice with corrective feedback. The words and skills will rotate based on lesson number and the automated data collected within the technology. The AAC user will get exposure to four skills per lesson.

Behavioral: ALLSTAR

ALLSTAR-I*

EXPERIMENTAL

In ALLSTAR-I\* condition, this group will receive explicit instruction in encoding and phoneme-grapheme knowledge, adding an integrative decoding and encoding approach within the lessons. Studies have shown that combining instruction on phonological awareness and letter-sound correspondences with word reading and spelling better develops students' word reading and spelling skills. These integrated lessons will be incorporated starting at lesson 20 and will include the features based on a refined intervention including the "Hear, Say, Type, Read, Use" strategy.

Behavioral: ALLSTAR

Interventions

ALLSTAR BEHAVIORAL

The ALL app comes with lessons in early literacy skills, with three tiers of lessons available. Both intervention groups will use ALLSTAR materials, including an implementation binder and the ALL app. Both intervention groups will also receive daily instruction by a trained service provider (\~30 mins. Per day). Additionally, in support of best practices, both groups will receive phonics instruction and use of explicit and systematic instruction for four skills per day and 50 trials per lesson. Lessons will differ based on skills targeted.

ALLSTAR-I*; ALLSTAR-SC

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Have complex communication needs and use AAC,
• are ages 5-12,
• per report can follow two-step directions,
• symbolic communicators with at least 75 words on the CDI and mean length of utterance greater than 2
• can match letters and words with greater than 90% accuracy,
• can identify letter-sound correspondences from a field of 4 with greater than 70% accuracy
• can identify common photographs used to represent words in the study (e.g., touch the picture of a hat, touch hot) with greater than 80% accuracy,
• can sit to work in a minimum of 5 min. intervals
• decoding or encoding at less than 40% accuracy based on parent or provider report and screening results;
• demonstrate functional vision and hearing

You may not qualify if:

• Do not have complex communication needs / can speak and do not need AAC,
• Younger than 5 or older than 12 years of age,
• Can not follow two-step directions,
• Are not symbolic communicators with at least 75 words on the CDI and not combining at least 2 symbols
• Can not match letters and words with \>90% accuracy,
• Can not identify letter-sound correspondences from a field of 4 with greater than 70% accuracy
• Can not identify common photographs used to represent words in the study (e.g., touch the picture of a hat, touch hot) with greater than 80% accuracy,
• Can not attend to work for 5 mins.
• decoding or encoding at more than 40% accuracy based on parent or provider report and screening results;
• Do not have corrected or functional vision and hearing

Sponsors & Collaborators

• Penn State University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Pennsylvania State University

State College, Pennsylvania, 16803, United States

Location

MeSH Terms

Conditions

Literacy; Nonverbal Communication; Communication; Autistic Disorder; Intellectual Disability

Condition Hierarchy (Ancestors)

Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 30 children will receive ALLSTAR - SC (standard use of ALLSTAR) and 30 children will receive ALLSTAR - I (integrated approach)

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: De-identified IPD will be made publicly available through the Open Science Framework (OSF; https://osf.io) in open-access formats (e.g., Excel or CSV files). Data will be accessible without restriction to researchers and the public. The data will be available beginning after publication of the primary study results and will remain available indefinitely. A direct link to the OSF repository will be provided in the ClinicalTrials.gov record in the Available IPD/Information field once the data are posted.

Locations

US (1)