Literacy Instruction Through Media for Everyone

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Efficacy and Mechanisms of Media and Storybook Interventions to Promote Children's Early Literacy Skills Via Caregiver Engagement

ClinicalTrials.gov ID

NCT06796790

Acronym / sponsor ID

LIME / AWD - 118236

Conditions

Media Effects on Literacy Gains in Young Children

Keywords

Literacy, Media, Shared reading, Poverty, Parents, Intervention, Preschool, Television

Study type

Interventional

Recruitment status

Recruiting

Enrolment

450 participants (estimated)

Lead sponsor

Ohio State UniversityUniversity, hospital or other

Collaborators

University of Central Florida, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study start

11 Jul 2025 (actual)

Primary completion

31 Aug 2029 (estimated)

Study completion

31 Aug 2029 (estimated)

First posted

28 Jan 2025 (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.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (investigator, outcomes assessor)

Number of arms

3

Model description

This study uses a randomized controlled trial hybrid type 2 design with three planned variations: (1) caregiver-led media-based early literacy intervention, (2) caregiver-led shared reading early literacy intervention, and (3) business-as-usual control. Literacy based media and shared reading will be used that promote literacy learning. Families enrolled in groups (1) and (2) will complete 12 weeks intervention. Families in all groups will also have follow ups at 3-, 6-, and 12-months post-intervention to test long-term effects. Families will digitally log their intervention sessions to track adherence as well as audio record 1 weekly session. Caregivers will be surveyed pre-intervention on other family characteristics and children will be assessed at pre-intervention, post-intervention, 3-, 6-, and 12-months post-intervention.

Who may qualify

Ages

42 to 57 months

Sex

All

Healthy volunteers

Accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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).

2. 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).

3. 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).

4. 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.

5. 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).

6. 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).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
• Individual participant dataSharing planned: Yes. This project will generate quantitative data from 450 families and children, which will be used to assess the efficacy of a media-based early literacy intervention. The data will be collected via direct assessments, questionnaires, applications loaded onto provided tablets, and audio and video observations. The primary final, cleaned data will consist of a single comma-delimited file for all valid responses. Transcription records will be stored as text files and audio/video files will be stored as MP3/4 files. Upon publication of major findings from the proposed study, the primary data file, transcripts, and audio and video files will be shared with other researchers through the Open Science Framework (primary comma-delimited data file), Databrary (audio and video files), and CHILDES/TalkBank (transcripts).

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.

1 site in 1 country: see every site and its status.