Not Yet RecruitingPhase 1/2

Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners

United States60 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range

5 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * • 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; * D…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent correct on Early Literacy Assessment (ELA)

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

Trial details

NCT IDNCT07384156

SponsorPenn State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-02-28

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