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.

Literacy skills enhance public health outcomes (employment, safety, well-being, and social engagement). Additionally and critically, for individuals who cannot speak and use augmentative and alternative communication (AAC; pointing to pictures, using a speech generating device), literacy skills support precise communication by allowing individuals to spell the exact words they wish to communicate. However, over 90% of AAC users leave high school illiterate. The long-term goal for this project is improve language and literacy outcomes in individuals who use AAC, consequently improving health and well-being outcomes. While recent research underscores the importance of explicit literacy instruction that integrates decoding and encoding, encoding is rarely taught to AAC users, and it is not yet known if this approach will yield better language and literacy outcomes among AAC users. The focus of the current proposal is to teach decoding and encoding using an integrated approach to instruction with an existing literacy curriculum, ALLSTAR. ALLSTAR and approaches using the ALL app have resulted in learning across all AAC users, with large to very large effect sizes observed (Tau-U ranges: .63 - 1.0) and large gains (+44% on pre-post ELA assessment).

The project goal is to: (1) adapt and evaluate the effect of an integrated approach in an AAC literacy intervention on CVC decoding and encoding using an iterative single subject design; (2) evaluate the effect of adding the integrated "spell-to-read" approach to ALLSTAR using an RCT (N=60); and (3) assess the acceptability, feasibility, and adoptability of the literacy lessons by practitioners, in order to understand the barriers and facilitators that influence their uptake, ultimately increasing the use of evidence-based literacy instruction for AAC users. Data measurements related to the respective aims above, include: (1) percent gains and intervention effectiveness, (2) gains on Pre, Mid, and Post scores on Early Literacy Assessment (letter-sounds, sound blending, phoneme segmentation, decoding, irregular sight words, and encoding); and (3) thematic analysis and scores on the Feasibility Adoption Acceptability Questionnaire (FAAQ), completed at three timepoints throughout each study. Our expected outcome is the development of an effective and adoptable literacy intervention for children who use AAC.

The significance of this work is that it will advance a new intervention paradigm for AAC users that capitalizes on an explicit connection between literacy and communication to foster AAC users who can communicate orthographically and ultimately more precisely what they wish to express. This proposal is timely, in that it is responsive to NIDCD's mission and responsive to and collaborative with AAC users. The project has the potential for high clinical impact in changing poor literacy outcomes for a population that is unjustly denied evidence-based literacy instruction.

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;
  • Do not have corrected or functional vision and hearing

De-identified individual participant data (IPD) will be shared. IPD will include de-identified survey and questionnaire responses, coded interview data (themes only, with no direct identifiers), and analyzable outcome data such as pre-post measures of decoding, encoding, and English Language Arts (ELA) performance (e.g., scores and percentage gains). No information that could reasonably identify individual participants will be shared.

Beginning 1 year after publication with no end date

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.