Purpose

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.

Condition

Eligibility

Eligible Ages
Between 42 Months and 57 Months
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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
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.
  • 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.
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.

Recruiting Locations

The Ohio State University Crane Center for Early Childhood
Columbus, Ohio 43201
Contact:
Eileen L Donnally, Master of Science
614-247-5897
donnally.7@osu.edu

More Details

NCT ID
NCT06796790
Status
Recruiting
Sponsor
Ohio State University

Study Contact

Eileen L Donnally, Master of Science
614-247-5897
donnally.7@osu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.