NCT06796790

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jul 2025Aug 2029

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 11, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

January 22, 2025

Last Update Submit

February 19, 2026

Conditions

Keywords

LiteracyMediaShared readingPovertyParentsInterventionPreschoolTelevision

Outcome Measures

Primary Outcomes (6)

  • Print concept knowledge

    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

    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

    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

  • Phonological Awareness

    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

  • Word reading

    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

    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

Secondary Outcomes (5)

  • Enjoyment of intervention activities

    Four times per week during the 12-week intervention and at posttest after the intervention

  • Perceived value of intervention activities

    At posttest after the 12 week intervention period

  • Ease of Scheduling

    At posttest after the 12 week intervention period

  • Caregiver Adherence

    Throughout the 12-week intervention

  • Quantity of print-related talk

    Throughout the 12-week intervention

Study Arms (3)

Media instruction

EXPERIMENTAL

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: Media instruction

Storybook instruction

ACTIVE COMPARATOR

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.

Behavioral: Storybook intervention

Business-as-usual control

NO INTERVENTION

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.

Interventions

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

Media 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.

Storybook instruction

Eligibility Criteria

Age42 Months - 57 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • between 42 and 57 months at enrollment
  • minimally verbal in English
  • caregiver sufficiently proficient in English
  • does not have severe intellectual disability

You may not qualify if:

  • under 42 months
  • over 57 months at enrollment
  • severe intellectual disability
  • not proficient in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Crane Center for Early Childhood

Columbus, Ohio, 43201, United States

RECRUITING

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Rebecca A Dore, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen L Donnally, Master of Science

CONTACT

Rebecca A Dore, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

July 11, 2025

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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).

Time Frame
Data will be made available upon publication of major findings from the proposed study. Study data deposited in the OSF, Databrary, and CHILDES/TalkBank will be available to the research community in perpetuity.
Access Criteria
Deidentified datasets will be made available as public use data on the OSF. Data with potentially personally identifiable information, such as audio or video, will be shared in more restricted manner via Databrary. Databrary provides data access to authorized users who have been granted secure access by Databrary's administrators. Only researchers with Principal Investigator status from institutions with Institutional Review Boards or similar review entities, or researchers affiliated with Principal Investigators, will be authorized for access. Transcripts will be shared via CHILDES/TalkBank and will be redacted as needed to remove potentially personally identifiable information.

Locations