Testing an App-Based Approach to Reading and Screen Time Guidance for Parents of Infants

NCT05508282 | Completed

• 1 other identifier: 2021-0635
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The American Academy of Pediatrics (AAP) recommends that parents read to their children as often as possible beginning in infancy and limits on screen time at all ages, yet many families question the value of reading to infants and are uncertain how to do so, and screen time is rising. This proposal is highly relevant to public health in that it involves a "how-to" approach to reading with infants and limiting screen time that is delivered during pediatric well-child visits within an established program (Reach Out and Read) using innovative materials: specially designed children's books and animated educational videos featured in a new mobile app (Reading Bees). It addresses important research gaps, compliments existing programs and empowers families, particularly from underserved backgrounds, to read more interactively and enjoyably with their babies, limit screen time, and improve early literacy skills, relationships and health outcomes.

Conditions

Literacy; Parent-Child Relations; Language Development

Outcome Measures

Primary Outcomes (6)

• Feasibility of intervention

  Feasibility of Reading Bees app for reading and screen time guidance; includes time of presentation and barriers encountered

  Baseline visit (0-2 months)

• Usability - reading and screen time materials

  Brief survey adapted from prior work involving anticipated usefulness and parental plans to use the infant reading book (SHARE This Book) and related content provided in the Reading Bees app. Items are categorical, Likert scale.

  Baseline visit (0-2 months) for reading, 6-month visit for screen time. Higher scores suggest greater usability.

• Efficacy - language

  MacArthur-Bates Communicative Development Inventories, a validated parent-report measure of child language. Given time and possible literacy constraints, the Words \& Gestures Short Form will be used.

  12-month visit

• Efficacy - change in quantitative home reading behaviors

  Books in the home, reading frequency and routines (StimQ Reading subscale). Higher score suggests more stimulating reading environment.

  Change between 6- and 12-month visits compared between groups.

• Efficacy - digital media use (screen time)

  ScreenQ-I/T report measure/survey reflecting AAP screen time guidelines involving access to screens, frequency, content and co-viewing. Higher score reflects greater non-adherence with guidelines. Higher score suggests greater non-adherence with AAP guidelines and subsequently higher risk of adverse impacts. Range is 0-20 points.

  12-month visit

• Efficacy - change in qualitative home reading behaviors

  Shared reading quality/interactivity (SharePR report measure). Higher score suggests higher quality of shared reading. Range is 0-30 points.

  Change between 6- and 12-month visits compared between groups.

Secondary Outcomes (2)

• Video Observation of Shared Reading - Reading Quality

  Change between 6- and 12-month visits compared between groups.

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

  Change Between 6- and 12-month visits compared between groups.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Reading Bees app and children's book to enhance parent-infant reading quality (0-2 month visit); Behavioral: Reading Bees app and children's book to encourage alternatives to digital media (6-month visit)

Control

NO INTERVENTION

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

Interventions

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

The reading intervention will be provided at the baseline clinic well-visit (0-2 months), and is based on the SHARE/STEP approach.

Intervention

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

The digital media (screen time) intervention will be provided at the 6-month clinic well-visit and is based on Baby Unplugged materials (book and app content).

Intervention

Eligibility Criteria

• Age: 0 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• child age at enrollment less than 2.5 months old,
• no documented history of neurologic insult, extreme prematurity (\<32-weeks), or neurodevelopmental condition conveying risk of language delays,
• custodial parent present is at least 18-years old,
• custodial parent present is fluent in English without need of an interpreter, 5) child has no acute illness,
• parent has an Android or iOS-compatible smartphone.
• The subset of parent-child dyads recruited for video observation will be on a first-come, first-served basis from those enrolled in the parent study.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• John Hutton, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Parents will be advised of the purpose of the study in general terms (how parents and babies interact at home) yet not the behaviors or outcomes of interest.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized trial with two arms: intervention (enhanced reading \& screen time guidance using a new mobile app) and control (usual guidance).

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: August 19, 2022
• Study Start: June 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)