What side effects are associated with this type of intervention?

The most common treatments for improving literacy, such as educational materials and guidance on reading and screen time limitation, generally have minimal side effects. Potential side effects may include initial resistance or frustration from children as they adapt to new routines, and possible increased screen time if not properly managed. However, these interventions are designed to be beneficial and supportive, aiming to enhance early literacy skills and overall development.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of literacy. Interventions for improving literacy skills in children typically involve educational programs and tools rather than pharmacological treatments. The Reading Bees Mobile App, which provides educational materials and guidance on reading and screen time limitation, represents a type of intervention aimed at promoting early literacy skills through interactive and enjoyable reading practices. Such educational interventions are commonly recommended by pediatric and educational experts to enhance literacy development in children.

What other types of research exist?

Promising alternatives to the Reading Bees Mobile App for literacy patients include: 1) MatHealth app, which supports maternal health and has been found acceptable and feasible among illiterate pregnant women in Uganda. 2) Smokefree.gov, which offers interactive and tailored web-based tools, including apps, to support smoking cessation and healthy habits, and could be adapted for literacy education. 3) Reach Out and Read program, which integrates reading guidance into pediatric well-child visits and could be enhanced with additional digital resources.

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App-Based Reading and Screen Time Guidance for Parent-Child Relationship

N/A

Waitlist Available

Led By John Hutton, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between 6- and 12-month visits compared between groups.

Awards & highlights

No Placebo-Only Group

Summary

This trial uses special books and videos through an app to help parents read to their babies and limit screen time. It targets low-income families who may not have much experience with reading to their children. The program makes reading fun and engaging, which helps babies' brain development and reduces screen time.

Who is the study for?

This trial is for parents with infants under 2.5 months old who speak English fluently and own a smartphone compatible with the Reading Bees app. It's not for those whose children have certain health conditions like extreme prematurity or risk of language delays.

What is being tested?

The study tests an app-based program, Reading Bees, which guides parents on reading to their infants and managing screen time. The intervention includes using the app along with specially designed books during pediatric visits.

What are the potential side effects?

There are no direct medical side effects since this trial involves educational guidance rather than medication. However, there may be indirect effects on family routines or infant behavior as new practices are introduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between 6- and 12-month visits compared between groups.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between 6- and 12-month visits compared between groups.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between 6- and 12-month visits compared between groups. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy - change in qualitative home reading behaviors

Efficacy - change in quantitative home reading behaviors

Efficacy - digital media use (screen time)

+3 more

Secondary study objectives

Video Observation of Shared Reading - Change in Parent-Child Bonding

Video Observation of Shared Reading - Reading Quality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment2 Interventions

These parents will have a new mobile app (Reading Bees) installed onto their smartphone during a baseline clinic visit between 0 and 2-months old. They will also receive a specially designed children's book modeling the SHARE/STEP approach to reading with infants. At 6-months, these parents will also receive guidance regarding limiting digital media use (screen time) using content in the app and a specially designed children's book. They will also receive usual guidance during clinic visits via the Reach Out and Read program

Group II: ControlActive Control1 Intervention

These parents will receive usual reading and screen time guidance during pediatric clinic visits, including via the Reach Out and Read program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reading Bees app and children's book to enhance parent-infant reading quality (0-2 month visit)

2022

N/A

~160

Reading Bees app and children's book to encourage alternatives to digital media (6-month visit)

2022

N/A

~160

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Reading Bees Mobile App intervention enhances literacy through educational materials that improve phonologic awareness and letter-sound relationships, and through guidance that promotes interactive shared reading. Limiting screen time reduces distractions, allowing children to focus on literacy activities. These mechanisms are crucial as they foster early literacy skills, improve language development, and create a conducive learning environment, which are essential for the literacy development of young children.

Relative Effectiveness of Reading Intervention Programs for Adults with Low Literacy.Efficacy of learning strategies instruction in adult basic education.Efficacy of a Reading Intervention for Middle School Students Identified with Learning Disabilities.