Enhancing Orthographic Communication and Literacy Outcomes for AAC Learners
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age5-12
SponsorPenn State University
About this trial
The goal of this clinical trial is to determine whether adding Integrated Decoding and Encoding instruction to the ALLSTAR literacy program improves reading outcomes for students with significant literacy and communication needs. The study will also examine how students' reading skills change over time across instructional conditions.
The main questions it aims to answer are:
Do students who receive ALLSTAR with Integrated Decoding and Encoding instruction demonstrate greater improvements in literacy outcomes than students who receive ALLSTAR as standard care alone? How do students' literacy skills change from baseline to mid-intervention and post-intervention across the two instructional conditions? Researchers will compare two groups using a randomized controlled trial design. One group will receive 60 lessons of ALLSTAR as the standard of care (ALLSTAR-SC), and the other group will receive 60 lessons of ALLSTAR with the addition of Integrated Decoding and Encoding lessons (ALLSTAR-I\*). Literacy outcomes will be measured using repeated assessment probes at baseline (0 Lessons), after 30-40 lessons, and after 60 lessons to evaluate differences between groups and changes over time in the individuals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have complex communication needs and use AAC,
are ages 5-12,
per report can follow two-step directions,
symbolic communicators with at least 75 words on the CDI and mean length of utterance greater than 2
Disqualifiers
• Do not have complex communication needs / can speak and do not need AAC,
Younger than 5 or older than 12 years of age,
Can not follow two-step directions,
Are not symbolic communicators with at least 75 words on the CDI and not combining at least 2 symbols
Trial design
Design model
Parallel
Treatments tested in this trial
ALLSTAR
BehavioralThe ALL app comes with lessons in early literacy skills, with three tiers of lessons available. Both intervention groups will use ALLSTAR materials, including an implementation binder and the ALL app. Both intervention groups will also receive daily instruction by a trained service provider (\~30 mins. Per day). Additionally, in support of best practices, both groups will receive phonics instruction and use of explicit and systematic instruction for four skills per day and 50 trials per lesson. Lessons will differ based on skills targeted.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ALLSTAR-SCActive comparator 1 intervention
Group B: ALLSTAR-I*Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent correct on Early Literacy Assessment (ELA)
Early Literacy Assessment (ELA) is a 120 question measure that covers six literacy skills. It was specifically created for a population with minimal or no speech. The ELA will be used to assess progress in domains of: letter-sound correspondence, sound blending, decoding, grapheme-phoneme typing, and encoding.
Time frame
At study completion of the required 60 lessons, an average of 5 monthsSecondary outcomes
1
The difference between the two literacy interventions for individuals who have minimal or no speech
Scores from the Early Literacy Assessment (ELA) will be analyzed in this secondary outcome measure to look at the difference between the two interventions. The ELA has 120 questions. The total scores on ELA between the two interventions will be compared using independent t-tests and Cohens D.
Time frame
After study completion, an average of 5 monthsOther outcomes
1
Qualitative Analysis of Service Provider's Social Validity of the two literacy interventions
To measure the perceptions of implementation variables, a Feasibility Adoption Acceptability Questionnaire (FAAQ) will be completed. The FAAQ was used in our pilot studies and was developed based on the Evidence-Based Practice Attitude Scale (EBPAS). The FAAQ includes 8 Likert questions and 2 open-ended questions. The Qualitative analysis of these will help supporting understanding of acceptability, adoption, sustainment, and feasibility of the two literacy interventions.
Time frame
Three times through the course of the study, on average at 0, 10, and 20 weeks.Sponsors and contacts
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Penn State University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: