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

Summary

This trial will test a new program to help parents read to their infants and limit 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy - change in qualitative home reading behaviors

Efficacy - change in quantitative home reading behaviors

Efficacy - digital media use (screen time)

+3 more

Secondary outcome measures

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

Video Observation of Shared Reading - Reading Quality

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.

Do I qualify?Apply below to find out

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.

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Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

816 Previous Clinical Trials

6,574,982 Total Patients Enrolled

2 Trials studying Literacy

396 Patients Enrolled for Literacy

John Hutton, MDPrincipal InvestigatorAssistant Professor

Media Library

Reading Bees app and children's book to encourage alternatives to digital media Clinical Trial Eligibility Overview. Trial Name: NCT05508282 — N/A

Literacy Research Study Groups: Intervention, Control

Literacy Clinical Trial 2023: Reading Bees app and children's book to encourage alternatives to digital media Highlights & Side Effects. Trial Name: NCT05508282 — N/A

Reading Bees app and children's book to encourage alternatives to digital media 2023 Treatment Timeline for Medical Study. Trial Name: NCT05508282 — N/A

~62 spots leftby Jul 2025

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