Clinical trial NCT05508282: Testing an App-Based Approach to Reading and Screen Time Guidance for Parents of Infants
Official title: Reading Bees: Randomized Trial of an App-Based Approach to Reading (SHARE/STEP) and Screen Time Guidance for Parents of Infants During Pediatric Clinic Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Parent-Child Relations
Language Development
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single-blind randomized trial with two arms: intervention (enhanced reading \& screen time guidance using a new mobile app) and control (usual guidance).
Primary purpose: PREVENTION

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.

Detailed description: The first year of life is a time of rapid brain development where critical skills, attitudes and routines predictive of academic, relational and health outcomes are shaped. An infant's home literacy environment (HLE), including quality of parent-child ("shared") reading, can be a major source of nurturing in these areas. Screen time in infancy can displace parent-child interaction and impair learning. The American Academy of Pediatrics (AAP) recommends shared reading from early infancy and discouraging screen time before 18-months old. While discussion of reading occurs in primary care, it is inconsistent and shared reading during infancy is modest. Screen time at this age is prevalent, increasing and hard to address. Reach Out and Read (ROR) provides books and guidance at well-visits from newborn to 5-years old and serves \>5-million families/year. However, no structured approach to parent-infant reading has been developed. General urging to read at this age may be ineffective and fuel anxiety and "educational" screen time, especially in families of low-socioeconomic status (SES) with less experience. The long-term goal of this project is to establish a family-friendly approach to shared reading and screen time guidance in infancy. The objective of this application is to conduct a clinical trial of a "how-to" intervention alongside ROR compared to usual ROR, in families of low-SES. Intervention involves special children's books and videos in a new mobile app (Reading Bees). These introduce SHARE/STEP, a novel approach intended to enrich reading routines: Snuggle on lap, Hands on, show Affection, Respond (Stretch words, Talk about pictures, Explore sounds, Patience), Enjoy. A children's book encourages practice at home, and 3 animated videos provide extra guidance. Reading Bees also encourages parents to set goals, log daily reading and provides tips, awards and resources tailored to parent needs. Study staff will randomly enroll 93 families/group, collect Baseline data and deliver reading intervention at a Newborn, 1-month or 2-month visit. At the 6-month visit, screen time intervention will be introduced via the same approach (book, video in Reading Bees). Follow-up visits at 6- and 12-months will assess HLE, impression of materials, screen time and language. Reading and usage data will be accessed from Reading Bees app. Forty families/group will be invited to participate in video observation of shared reading in a private area prior to their child's 6- and 12-month old well-visit. These videos will be scored via two trained, independent coders applying both SHARE/STEP and social-emotional connection criteria (WECS scale). Our central hypothesis is that the Reading Bees intervention will be feasible during well-visits in early infancy, useful for families and effective to improve HLE and language and reduce screen time. The rationale is no similar intervention exists, current guidance is largely ineffective, and Reading Bees is synergistic and may be scaled within the ROR program and others such as home visiting. This research is significant and innovative in that it involves a novel approach to enhance parent-infant reading and limit screen time efficiently delivered during primary care, reinforces AAP guidelines and addresses NICHD/CDBB priority research areas. The expected outcome is successful testing of Reading Bees during a critical span of cognitive, relational and brain development, providing a foundation for further research and applications.

Eligibility criteria: Inclusion Criteria:

1. child age at enrollment less than 2.5 months old,
2. no documented history of neurologic insult, extreme prematurity (\<32-weeks), or neurodevelopmental condition conveying risk of language delays,
3. custodial parent present is at least 18-years old,
4. custodial parent present is fluent in English without need of an interpreter, 5) child has no acute illness,
5. 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.

Exclusion Criteria:

Violating the above inclusion criteria.

Primary outcomes:
measure: Feasibility of intervention
timeFrame: Baseline visit (0-2 months)
measure: Usability - reading and screen time materials
timeFrame: Baseline visit (0-2 months) for reading, 6-month visit for screen time. Higher scores suggest greater usability.
measure: Efficacy - language
timeFrame: 12-month visit
measure: Efficacy - change in quantitative home reading behaviors
timeFrame: Change between 6- and 12-month visits compared between groups.
measure: Efficacy - digital media use (screen time)
timeFrame: 12-month visit
measure: Efficacy - change in qualitative home reading behaviors
timeFrame: Change between 6- and 12-month visits compared between groups.
Secondary outcomes:
measure: Video Observation of Shared Reading - Reading Quality
timeFrame: Change between 6- and 12-month visits compared between groups.
measure: Video Observation of Shared Reading - Change in Parent-Child Bonding
timeFrame: Change Between 6- and 12-month visits compared between groups.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Assistant Professor
name: John Hutton, MD
role: PRINCIPAL_INVESTIGATOR
References: