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

Literacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05602181
• Other study ID #: 00018772
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

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

• 3 to 8 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

Related Conditions & MeSH terms

• Literacy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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