- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06796790
Literacy Instruction Through Media for Everyone (LIME)
Efficacy and Mechanisms of Media and Storybook Interventions to Promote Children's Early Literacy Skills Via Caregiver Engagement
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eileen L Donnally, Master of Science
- Phone Number: 614-247-5897
- Email: donnally.7@osu.edu
Study Contact Backup
- Name: Rebecca A Dore, PhD
- Phone Number: (614) 247-7488
- Email: dore.13@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43201
- Recruiting
- The Ohio State University Crane Center for Early Childhood
-
Sub-Investigator:
- Laura M Justice, PhD
-
Sub-Investigator:
- Hui Jiang, PhD
-
Contact:
- Eileen L Donnally, Master of Science
- Phone Number: 614-247-5897
- Email: donnally.7@osu.edu
-
Contact:
- Rebecca A Dore, PhD
- Phone Number: (614) 247-7488
- Email: dore.13@osu.edu
-
Principal Investigator:
- Rebecca A Dore, PhD
-
Sub-Investigator:
- Amy Nathanson, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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
|
|
Active Comparator: Storybook instruction
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.
|
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.
|
|
No Intervention: Business-as-usual control
Caregivers will be asked to log any joint learning activities they engage in with their child but will not be provided with any specific materials or instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
At pretest after enrollment and at posttest after the 12 week intervention period
|
|
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). |
At pretest after enrollment and at posttest after the 12 week intervention period
|
|
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).
|
At pretest after enrollment and at posttest after the 12 week intervention period
|
|
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).
|
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
|
|
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).
|
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
|
|
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.
|
At pretest after enrollment and at posttest after the 12 week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Adherence
Time Frame: Throughout the 12-week intervention
|
Caregivers will be trained in procedures for using a digital Qualtrics log to track use of the intervention activities.
The log will be preloaded as a bookmark onto the home screen of each tablet and will ask participants to note the episode watched.
|
Throughout the 12-week intervention
|
|
Quantity of print-related talk
Time Frame: Throughout the 12-week intervention
|
Audio-recorded intervention sessions will be coded by trained research staff to document the quantity of print-related talk within each session.
Specifically, the Fidelity Coding Catalog (FCC) coding scheme was developed to document caregiver-child talk during reading sessions and is a reliable event-based coding system measuring frequency and quantity of print-focused talk.
The FCC captures, for instance, every adult utterance that contains print-related key words, such as letter, word, and read.
The quantity of print-related talk as measured by the FCC is an important index of intervention adherence but also represents a key mechanism through which intervention impacts early literacy development (McGinty et al., 2011).
|
Throughout the 12-week intervention
|
|
Enjoyment of intervention activities
Time Frame: Four times per week during the 12-week intervention and at posttest after the intervention
|
Enjoyment of intervention activities is measured to assess the extent to which the media intervention circumvents barriers related to caregiver difficulty and discomfort with reading.
Enjoyment will be measured with three items: "How do you think today's session went?", "How much did you enjoy these sessions?",
and "How uncomfortable or difficult did you find these sessions?"
|
Four times per week during the 12-week intervention and at posttest after the intervention
|
|
Perceived value of intervention activities
Time Frame: At posttest after the 12 week intervention period
|
Perceived value of intervention activities is measured to assess the extent to which the media intervention reduces barriers related to a limited understanding of the benefits of shared-reading activities.
Two items are used: "How much did these sessions help your child's development?"
and "How much did these sessions help your child learn about letters and how to read simple words?".
|
At posttest after the 12 week intervention period
|
|
Ease of Scheduling
Time Frame: At posttest after the 12 week intervention period
|
Ease of fitting activities into schedule is measured to assess the extent to which the media intervention reduces the time pressure barrier.
One item asks: "How easy was it to fit this session into your family's schedule?"
|
At posttest after the 12 week intervention period
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca A Dore, PhD, Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWD - 118236
- R01HD114687 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Media Effects on Literacy Gains in Young Children
-
Swiss Federal Institute of TechnologyCompletedEffects of Exergaming on Cognitive Functions in Young AthletenSwitzerland
-
Selcuk UniversityCompletedEffects of Plyometric Training on Balance, Joint Position Sense, and Explosive Strength in Healthy Young Taekwondo AthletesTurkey (Türkiye)
-
Coşkun YILMAZCompletedHEALTHY PREADOLESCENT MALE | Effects of Running on Daily Variation in Healthy Adolescent ChildrenTurkey
-
Hadassah Medical OrganizationUnknownEffects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in ChildrenIsrael
Clinical Trials on Media instruction
-
Henrik GudbergsenCharles University, Czech Republic; Region Capital DenmarkCompletedRheumatoid ArthritisDenmark
-
Universiti Sains MalaysiaRecruitingUrologic Diseases | Hematuria | Bladder Ca | Bladder StoneMalaysia
-
Oslo Metropolitan UniversityNorwegian Institute of Public HealthActive, not recruitingInfection | Infection ControlNorway
-
Wake Forest University Health SciencesCompleted
-
National Research Centre for the Working Environment...Novo Nordisk A/SCompletedMusculoskeletal DisordersDenmark
-
Kocaeli Sağlık ve Teknoloji ÜniversitesiCompletedPhysical Therapy | Virtual Reality | Education | NeurorehabilitationTurkey (Türkiye)
-
George Washington UniversityRecruiting
-
VA Pittsburgh Healthcare SystemUniversity of PittsburghCompleted
-
University of Missouri-ColumbiaTerminatedAtopic DermatitisUnited States
-
Lütfiye ParlakCompletedUniversity StudentTurkey