LiteracyNCT05602181
Effect of the ALL App on Literacy for Children Who Use AAC
A study testing ALL Phonics Instruction and ALL Sight Word Instruction in people with Literacy, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Literacy
- What is being tested?
- ALL Phonics Instruction and ALL Sight Word Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
State College, Pennsylvania, 16803
About this study
Official title: 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:
Read more
- 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
- Understand how many trials/how much time it takes to acquire each of the 6 early literacy skill assessed
- 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.
- 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).
- Conditions
- Literacy
- Being tested
- ALL Phonics Instruction, ALL Sight Word Instruction
- Keywords
- AAC
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALL Phonics InstructionBehavioural
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 InstructionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ALL Phonics Instruction | Experimental | 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. Receives: Behavioral: ALL Phonics Instruction |
| ALL Sight Word | Active comparator | 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. Receives: Behavioral: ALL Sight Word Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 8 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Oct 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Caron, Penn State University
- Investigators
- Jessica Caron, Ph.D., Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602181
- Sponsor's protocol ID
- 00018772
- Status last verified
- Jun 2024
- First submitted
- 10 Oct 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic information, as well as raw scores on literacy assessment measures.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Accessible Literacy Learning (ALL) App on Early Literacy Skills by Children Who Use Augmentative and Alternative Communication
- ClinicalTrials.gov ID
- NCT05602181
- Acronym / sponsor ID
- 00018772
- Conditions
- Literacy
- Keywords
- AAC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Understand how many trials/how much time it takes to acquire each of the 6 early literacy skill assessed
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALL Phonics Instruction | Experimental | Behavioral: ALL Phonics InstructionLessons 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. |
| ALL Sight Word | Active comparator | Behavioral: ALL Sight Word InstructionLessons 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. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALL Phonics InstructionThe 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. | Behavioural | ALL Phonics Instruction |
| ALL Sight Word InstructionThe 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. | Behavioural | ALL Sight Word |
Primary outcome
Change from Baseline Scores on the Early Literacy Assessment
Time frame: Through study completion, an average of 8 months
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.
2 secondary outcomes
Data from the Feasibility Adoption Acceptability Questionnaire (FAAQ)
Time frame: Through study completion, an average of 8 months
Treatment and Acceptability Rating Form - Revised
Time frame: Through study completion, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Yes. Demographic information, as well as raw scores on literacy assessment measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Caron, Ph.D. principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALL Phonics Instruction and ALL Sight Word Instruction in people with Literacy, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Scores on the Early Literacy Assessment (time frame: Through study completion, an average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.