LiteracyPhase 1/2NCT07384156
Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners
A Phase 1/2 study testing ALLSTAR in people with Literacy and Communication, Nonverbal, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Literacy, Communication, Nonverbal
- What is being tested?
- ALLSTAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 28 Feb 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- • 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Pennsylvania State University
State College, Pennsylvania, 16803
About this study
Official title: Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners: Investigating Effective Instructional Strategies
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.
Read the detailed description
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.
- Conditions
- Literacy, Communication, Nonverbal
- Being tested
- ALLSTAR
- Keywords
- literacy, augmentative and alternative communication, nonverbal, Communication, Autism, Intellectual Disabilities
- Medical subject headings
- Literacy, Nonverbal Communication, Communication, Autistic Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLSTARBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ALLSTAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Scores from the Early Literacy Assessment (ELA) will be analyzed in this secondary outcome measure to look at the difference between the two interventions. The ELA has 120 questions. The total scores on ELA between the two interventions will be compared using independent t-tests and Cohens D.
Measured: After study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion28 Feb 2031 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 children will receive ALLSTAR - SC (standard use of ALLSTAR) and 30 children will receive ALLSTAR - I (integrated approach)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jessica Caron, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384156
- Sponsor's protocol ID
- 251267
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners: Investigating Effective Instructional Strategies
- ClinicalTrials.gov ID
- NCT07384156
- Acronym / sponsor ID
- 251267
- Conditions
- Literacy, Communication, Nonverbal
- Keywords
- literacy, augmentative and alternative communication, nonverbal, Communication, Autism, Intellectual Disabilities
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 28 Feb 2031 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 30 children will receive ALLSTAR - SC (standard use of ALLSTAR) and 30 children will receive ALLSTAR - I (integrated approach)
| Arm | Type | Receives |
|---|---|---|
| ALLSTAR-SC | Active comparator | Behavioral: ALLSTARThe 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. |
| ALLSTAR-I* | Experimental | Behavioral: ALLSTARIn 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (10 listed)
- • Do not have complex communication needs / can speak and do not need AAC,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLSTARThe 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. | Behavioural | ALLSTAR-I*, ALLSTAR-SC |
Primary outcome
Percent correct on Early Literacy Assessment (ELA)
Time frame: At study completion of the required 60 lessons, an average of 5 months
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.
1 secondary outcome
The difference between the two literacy interventions for individuals who have minimal or no speech
Time frame: After study completion, an average of 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALLSTAR in people with Literacy and Communication, Nonverbal, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent correct on Early Literacy Assessment (ELA) (time frame: At study completion of the required 60 lessons, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.