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NCT07384156 · ClinicalTrials.gov registry record · Phase 1
Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners
A Phase 1 study, sponsored by Penn State University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT07384156: Clinical Trial Phase 1 study, sponsored by Penn State University.
NCT07384156 is a Phase 1 study that has not yet begun recruiting, run by Penn State University. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07384156, a Phase 1 study, has not yet begun recruiting, sponsored by Penn State University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- BEHAVIORAL ALLSTAR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-01 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 1 |
What is known before NCT07384156 opens enrollment
NCT07384156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which ALLSTAR is the first listed.
NCT07384156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07384156 about?
NCT07384156 is a clinical study titled "Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners". 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 t...
What is the current status of trial NCT07384156?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-03-01. Estimated completion is 2031-02-28.
What interventions are being tested in trial NCT07384156?
The interventions under investigation include: ALLSTAR (BEHAVIORAL).
Who is sponsoring clinical trial NCT07384156?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07384156's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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