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?

This trial explores whether new techniques added to the ALLSTAR literacy program can help children with significant literacy and communication needs improve their reading skills. It compares the standard ALLSTAR lessons with an enhanced version that includes Integrated Decoding and Encoding instruction, focusing on understanding and using letter sounds more effectively. The study tracks progress at different stages to determine which method works better. Children who use AAC (alternative communication devices), can follow simple directions, and have basic literacy skills might be suitable for this study. As a Phase 1/Phase 2 trial, this research aims to understand how the new techniques work and measure their effectiveness in an initial group, offering participants a chance to contribute to groundbreaking literacy advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ALLSTAR literacy program, currently under testing in this clinical trial, is generally well-received. This trial is in its early stages and focuses on the program's safety for participants. Although no detailed reports of negative effects specific to ALLSTAR exist, the early stage means researchers are closely monitoring for any possible side effects.

The trial includes two groups: one using standard ALLSTAR lessons and the other receiving additional Integrated Decoding and Encoding instruction. So far, no specific data indicates harmful effects for either group. The main goal is to improve reading skills, and the program is designed to be supportive and educational. Participants can feel assured that researchers prioritize safety in these studies.12345

Why are researchers excited about this trial?

Researchers are excited about the ALLSTAR Program because it offers a fresh approach to teaching literacy skills to AAC (Augmentative and Alternative Communication) users. Unlike standard methods that often rely on static lessons and limited interaction, ALLSTAR utilizes an interactive app with dynamic lessons that adapt based on user progress. The ALLSTAR-I* arm further enhances learning by integrating a comprehensive strategy called "Hear, Say, Type, Read, Use," which combines phonological awareness with hands-on activities. This innovative method aims to accelerate learning and improve reading and spelling skills more effectively than traditional approaches.

What evidence suggests that this trial's treatments could be effective for improving literacy outcomes?

Research has shown that the ALLSTAR literacy program helps students with significant reading and communication challenges improve their reading skills. In this trial, participants will be assigned to different treatment arms. The ALLSTAR-I* approach, one of the study arms, includes special lessons on breaking down and building words and has boosted students' ability to read and spell words. Studies have demonstrated that teaching students to recognize sounds in words and match them with letters improves these skills. Previous research suggests that these combined lessons can be more effective than traditional methods. Therefore, the ALLSTAR-I* might lead to better reading results than the standard ALLSTAR program, which is another arm in this trial.13678

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+

Citations

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