Effect of the ALL App on Literacy for Children Who Use AAC

Effects of the Accessible Literacy Learning (ALL) App on Early Literacy Skills by Children Who Use Augmentative and Alternative Communication

The goal of this clinical trial is to test a phonics-based literacy program for children with limited or no speech who use augmentative and alternative communication.

More specifically, this study aims to:

1. Understand if using a literacy app (Accessible Literacy Learning) created to support individuals with limited or no speech, with instruction provided by a service provider, will increase their literacy skills
2. Understand how many trials/how much time it takes to acquire each of the 6 early literacy skill assessed
3. Understand if service providers think the Accessible Literacy Learning app is appropriate for this population that needs many literacy adaptions due to challenges with speech.
4. Understand if any characteristics lead to more learning of the skills, for example, diagnosis or age

Participants will be asked to complete 100 lessons using the app. The lessons will be phonics-based for the intervention group. The comparison group with use the same app and complete 100 lessons, but will only complete lessons in sight word (no phonics).

Study Overview

• Status: Enrolling by invitation
• Conditions: Literacy
• Intervention / Treatment: Behavioral: ALL Phonics Instruction; Behavioral: ALL Sight Word Instruction

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • State College, Pennsylvania, United States, 16803
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Students with CCN can participate if they meet the following criteria:

• 3 to 10 years old
• present with speech and communication skills that did not meet all of their daily communication needs (e.g., have an AAC system; less than 50% intelligible at the single word level to unfamiliar partners if using speech)
• follow one-step directions
• symbolic communicators with use of at least 50 words/signs/picture icons expressively,
• limited literacy skills (i.e., identify less than 26 letter-sound correspondences, 10 words during sound blending, 25 sight words on the screening assessment, and can spell less that 20 words)
• not receiving consistent phonologically-based direct literacy instruction or receiving instruction in less than 2 of the tested skills
• unimpaired or corrected vision and hearing
• access to an iPad

School support personnel (e.g., teachers, speech-pathologists, paraprofessionals) can participate if they meet the following criteria, per self-report:

• Speaks English
• Reads English
• 18 years of age or older
• Spending time directly working with an individual with CCN who needs to learn to read
• Willingness to implement the ALL curriculum and incorporate it into the daily educational plans

Exclusion Criteria:

Students cannot participate if they:

• are under 3 years of age
• do not present with severe speech disorders whereby they could use or benefit from AAC
• can't follow one-step directions
• are not symbolic communicators
• are able to read at the connected text level
• do not speak/understand English
• impaired and uncorrected vision and hearing
• do not have access to an iPad to use the ALL app

Support personnel cannot participate if they:

• do not speak English
• do not understand English
• have impaired vision and hearing that is not corrected and impacts reading and hearing the child they work with
• are not in daily direct contact with someone with CCN
• unwilling to attend trainings related to the ALL app
• unwilling to incorporate the ALL app into daily educational plans

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALL Phonics Instruction; Lessons for the treatment group will be 30-min. long using the ALL app with a known service provider. Lessons will include systematic instruction with four subskills per session (e.g., letter-sounds, sound blending, typing, and sight words). The words and subskills with rotate based on the data collected and the machine learning within the technology. The child will complete 100 lessons. The systematic instruction with subksills (e.g., sound blending, decoding) includes 10 trials per word and an instructional sequence that introduces the skill, two models, six trials of guided practice, and two trials of independent practice with corrective feedback.	Behavioral: ALL Phonics Instruction; The Accessible Literacy Learning (ALL) App is available in the app store and created by TobiiDynavox (an AAC device company). The ALL app is evidence informed and includes pre-made lessons in early phonics/phonological skills including: letter-sounds, sound blending, decoding, phoneme segmentation, sight words, and encoding. The materials made in the app are adapted and created for children with minimal or no speech.
Active Comparator: ALL Sight Word; Lessons for the comparison group will be 30-min. long using the ALL app with a known service provider. Lessons will include systematic instruction with sight words. The child will also complete 100 lessons.No phonics instruction will be provided to this group through the ALL app.	Behavioral: ALL Sight Word Instruction; The Accessible Literacy Learning (ALL) App is available in the app store and created by TobiiDynavox (an AAC device company). The ALL app is evidence informed and includes pre-made lessons in early phonics/phonological skills including: letter-sounds, sound blending, decoding, phoneme segmentation, sight words, and encoding. The materials made in the app are adapted and created for children with minimal or no speech. This group will only use the sight word lessons, as well as the library for sight word books. No phonics instruction will be provided through the app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Scores on the Early Literacy Assessment	We will examine the impact of literacy lessons delivered with the ALL technology on the change in scores on the Early Literacy Assessment (ELA) -specifically change in scores in the areas of letter-sounds, sound blending, phoneme segmentation, decoding, irregular sight words, and encoding.	Through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data from the Feasibility Adoption Acceptability Questionnaire (FAAQ)	To measure the perceptions of implementation variables the Feasibility Adoption Acceptability Questionnaire (FAAQ) will be completed at six timepoints throughout the study. Likert-scale questions (Scale of 1-5) across 10 questions, as well as 2 open responses.	Through study completion, an average of 8 months
Treatment and Acceptability Rating Form - Revised	Pre-post interviews using the Treatment and Acceptability Rating Form-Revised (TARF-R) [20] will examine which components of the ALL technology are perceived as helpful or hindering to progress as well as factors that may support high implementation fidelity.	Through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Jessica Caron, Ph.D., The Pennsylvania State University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: AAC
• Other Study ID Numbers: 00018772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic information, as well as raw scores on literacy assessment measures.
• IPD Sharing Time Frame: After analysis of results (approximately November 2025)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes