ALLSTAR Program for Literacy

Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Penn State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for children aged 5-12 with communication challenges who use AAC. They must be able to match letters and words, follow directions, have a basic vocabulary and understanding of letter sounds, recognize common pictures, and focus for short periods. Children with decoding or encoding skills below 40% are eligible.

Inclusion Criteria

I use tools to help me communicate.
I am between the ages of 5 and 12.
I can see and hear well enough for daily activities.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial literacy skills assessment using the Early Literacy Assessment (ELA)

1 week
1 visit (in-person)

Treatment

Participants receive 60 lessons of ALLSTAR literacy program, with or without Integrated Decoding and Encoding instruction

20 weeks
Weekly sessions

Mid-Intervention Assessment

Assessment of literacy skills after 30-40 lessons using the ELA

1 week
1 visit (in-person)

Post-Intervention Assessment

Final assessment of literacy skills after 60 lessons using the ELA

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in literacy skills and the acceptability of the intervention

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ALLSTAR

Trial Overview

The study tests if adding Integrated Decoding and Encoding to the ALLSTAR literacy program helps improve reading for kids with significant needs in literacy and communication. It's a randomized controlled trial comparing standard ALLSTAR (ALLSTAR-SC) against ALLSTAR plus extra lessons (ALLSTAR-I*).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ALLSTAR-I*Experimental Treatment1 Intervention
Group II: ALLSTAR-SCActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials
380
Recruited
131,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+