NCT06796790 · Ohio State University
Literacy Instruction Through Media for Everyone
(LIME)
What this study is about
The goal of this study is to determine whether an intervention to support caregivers in engaging with their children while using educational media together can improve children's early literacy skills, compared to an aligned shared book reading intervention and to no intervention.
View original scientific description
The goal of this study is to determine whether an intervention to support caregivers in engaging with their children while using educational media together can improve children's early literacy skills, compared to an aligned shared book reading intervention and to no intervention. Given that early literacy skills predict children's later academic learning, this home intervention, which aims to shape the communication patterns surrounding a common, family-friendly activity, has the potential to positively influence the trajectory of low income children's academic success. The investigators propose that amedia based activity will reduce barriers and increase adherence therefore increasing literacy skills over time.
Interventions
BEHAVIORAL
Media instruction
Caregivers will be asked to implement joint media sessions with their child four times per week for 12 weeks using lightly adapted versions of the commercially-available Super Why! program, which focuses on early literacy skills, including alphabet knowledge, rhyming, spelling, and print concepts. Sessions are anticipated to last 20 minutes. Caregivers will be trained by researchers on explicit strategies to use to promote children's learning. Caregivers will digitally log every session and audio record 1 session each week
BEHAVIORAL
Storybook intervention
Caregivers will be asked to implement joint storybook reading sessions with their child four times per week for 12 weeks using adapted versions of the commercially -available Super-Why! storybooks, which focus on early literacy skills including alphabet knowledge, rhyming, spelling, and print concepts. Sessions are anticipated to last 20 minutes. Caregivers will be trained by researchers on explicit strategies to use to promote children's learning. Caregivers will digitally log every session and audio record 1 session each week.
Primary outcome measures
Print concept knowledge
Time frame: At pretest after enrollment and at posttest after the 12 week intervention period
Children are administered the Preschool Word and Print Awareness (PWPA) measure (Justice et al., 2006), which examines children's knowledge of 16 basic print concepts. The PWPA has high inter-rater reliability (96% to 100%, Justice \& Ezell, 200), acceptable internal consistency (#= .7; Dobbs- Oates et al., 2015) and can reliably estimate preschoolers' print-concept knowledge (Justice et al., 2006).
Alphabet knowledge
Time frame: At pretest after enrollment and at posttest after the 12 week intervention period
Children are administered the Alphabet Knowledge subtest of the Phonological Awareness Literacy Screening - Preschool (PALS-PreK; Invernizzi et al., 2001). Children are presented with uppercase and lowercase letters printed in random order and receive a point for each letter named correctly. Cronbach's alphas average average .86. Inter-rater reliability is \>.96 (Invernizzi et al., 2004). The full PALS-PreK test is highly correlated with measures of reading ability (e.g., Test of Early Reading Ability, r= .67) and predicts later performance on a similar literacy measure (rs \> .53). Further, this subtest has high predictive validity in discriminating children who will later be identified as needing additional instruction (Invernizzi et al., 2001).
Name Writing
Time frame: At pretest after enrollment and at posttest after the 12 week intervention period
Children are administered the Name Writing subtest from the PALS-PreK. In the Name Writing subtest, the child is asked to draw a picture of themselves and then write their name. They are then asked to show the assessor their name. Only the written name is scored. This subtests has high inter-rater reliability (.99). As noted above, the full test has good convergent and predictive validity (Invernizzi et al., 2001).
Phonological Awareness
Time frame: At pretest after enrollment and at posttest after the 12 week intervention period
Children are administered two subtests from the PALS-PreK. In the Beginning Sound Awareness subtest, the child is asked to produce the beginning sound of a word. This subtests has acceptable reliability (# = .93) and inter-rater reliability is high (.99). As noted above, the full test has good convergent and predictive validity (Invernizzi et al., 2001). The Rhyme Awareness subtest was removed in February 2026 due to feasibility concerns identified in early study data.
Word reading
Time frame: At pretest after enrollment, at posttest after the 12 week intervention period, at 3-month follow up, at 6-month follow-up, and at 12- month follow up
At all timepoints, children are administered the Letter-Word Identification subtest of the Woodcock Johnson IV Test of Achievement (WJ IV; Schrank, McGrew \& Mather, 2014). This subtest requires children to identify or read isolated letters and words orally. This subtest has adequate internal-consistency (.94; Schrank \& Wendling, 2018). It has a high factor loading onto the Broad Reading cluster (.92; McGrew et al., 2014) which is highly correlated with other measures of reading like the Wechsler Individual Achievement Test (WIAT) Total Reading (.89; Schrank \& Wendling, 2018). It is strongly correlated with general school readiness (r = .84) as measured by the Differential Ability Scales (McGrew et al., 2014).
Spelling
Time frame: At pretest after enrollment, at posttest after the 12 week intervention period, at 3-month follow up, at 6-month follow-up, and at 12- month follow up
At all timepoints, children are administered the Spelling subtest from the WJ IV, requiring children to draw lines, trace and write letters, and spell orally presented words. This subtest has adequate internal-consistency reliability (.92; Schrank \& Wendling, 2018) and a high factor loading onto the Broad Written Language Cluster (.87), which is highly correlated with other measures of writing like WIAT Written Expression (.77; McGrew et al., 2014). This subtest is moderately correlated (r = .69) with general school readiness as measured by the Differential Ability Scales (McGrew et al., 2014).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- between 42 and 57 months at enrollment
- minimally verbal in English
- caregiver sufficiently proficient in English
- does not have severe intellectual disability
Exclusion criteria
- under 42 months
- over 57 months at enrollment
- severe intellectual disability
- not proficient in English
Where
- Columbus, Ohio
Collaborators
University of Central Florida, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations