Clinical trial NCT05602181: Effect of the ALL App on Literacy for Children Who Use AAC
Official title: Effects of the Accessible Literacy Learning (ALL) App on Early Literacy Skills by Children Who Use Augmentative and Alternative Communication
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Literacy
Keywords: AAC
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Scores on the Early Literacy Assessment
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
measure: Data from the Feasibility Adoption Acceptability Questionnaire (FAAQ)
timeFrame: Through study completion, an average of 8 months
measure: Treatment and Acceptability Rating Form - Revised
timeFrame: Through study completion, an average of 8 months
Other outcomes:
Locations:
city: State College
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Jessica Caron, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: