Clinical trial NCT06796790: Literacy Instruction Through Media for Everyone
Official title: Efficacy and Mechanisms of Media and Storybook Interventions to Promote Children's Early Literacy Skills Via Caregiver Engagement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Media Effects on Literacy Gains in Young Children
Keywords: Literacy
Media
Shared reading
Poverty
Parents
Intervention
Preschool
Television
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Central Florida
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-01-28
Enrollment: 450
Sex: ALL
Minimum age (years): 42
Maximum age (years): 57
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Detailed description: The proposed study draws upon an implementation science framework (Nilsen, 2015) to determine the extent to which a media-based caregiver-led intervention improves caregiver adherence and in turn children's early literacy development relative to a shared reading intervention. Caregiver-implemented shared reading interventions represent the 'current standard practice' for addressing early literacy needs, yet many caregivers cannot implement this practice with adequate adherence. This is particularly true for low-socioeconomic status families, in which shared reading may not be a conventional activity and barriers inhibit its use. The investigators propose-and test-that a media-based intervention reduces barriers to intervention implementation and increases social validity, leading to higher levels of adherence and, via mediation, enhanced child literacy outcomes. To establish this causal chain, the investigators mplement a media-based early literacy intervention, compare it to a highly aligned shared reading intervention, and measure (1) social validity of the intervention to test whether use of media circumvents barriers, (2) caregiver adherence (i.e., frequency and dosage), and (3) child early literacy skills gains immediately and over time. As the first causally interpretable study to compare media and shared reading as caregiver-led interventions, the proposed project will identify strategies to improve adherence in home-based interventions and inform development of interventions to improve school readiness among low-SES children.

Eligibility criteria: 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

Primary outcomes:
measure: Print concept knowledge
timeFrame: At pretest after enrollment and at posttest after the 12 week intervention period
measure: Alphabet knowledge
timeFrame: At pretest after enrollment and at posttest after the 12 week intervention period
measure: Name Writing
timeFrame: At pretest after enrollment and at posttest after the 12 week intervention period
measure: Phonological Awareness
timeFrame: At pretest after enrollment and at posttest after the 12 week intervention period
measure: Word reading
timeFrame: 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
measure: Spelling
timeFrame: 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:
measure: Enjoyment of intervention activities
timeFrame: Four times per week during the 12-week intervention and at posttest after the intervention
measure: Perceived value of intervention activities
timeFrame: At posttest after the 12 week intervention period
measure: Ease of Scheduling
timeFrame: At posttest after the 12 week intervention period
measure: Caregiver Adherence
timeFrame: Throughout the 12-week intervention
measure: Quantity of print-related talk
timeFrame: Throughout the 12-week intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Crane Center for Early Childhood
state: Ohio
Study officials:
affiliation: Ohio State University
name: Rebecca A Dore, PhD
role: PRINCIPAL_INVESTIGATOR
References: