Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners
Part of paid clinical trials in State College, Pennsylvania.
- Sponsor
- Penn State University
- Study ID
- NCT07384156
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Communication, Nonverbal
- Literacy
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 12 Years
- Healthy Volunteers
- Not accepted
Interventions
- ALLSTAR — BEHAVIORALThe 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 Details
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.
Key Dates
- Start date
- Mar 1, 2026
- Status verified
- Jan 2026
- Primary completion
- Feb 28, 2031
- Completion
- Feb 28, 2031
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: ALLSTAR-SCThe 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.
- Experimental: ALLSTAR-I*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.
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 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Pennsylvania State University | State College | Pennsylvania | 16803 | - |
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