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

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ClinicalTrials.gov Identifier: NCT05508282
Recruitment Status : Recruiting
First Posted : August 19, 2022
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Literacy Parent-Child Relations Language Development 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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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).
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : June 30, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Intervention

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

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

No Intervention: Control
These parents will receive usual reading and screen time guidance during pediatric clinic visits, including via the Reach Out and Read program.



Primary Outcome Measures :
  1. Feasibility of intervention [ Time Frame: Baseline visit (0-2 months) ]
    Feasibility of Reading Bees app for reading and screen time guidance; includes time of presentation and barriers encountered

  2. Usability - reading and screen time materials [ Time Frame: Baseline visit (0-2 months) for reading, 6-month visit for screen time. Higher scores suggest greater usability. ]
    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.

  3. Efficacy - language [ Time Frame: 12-month visit ]
    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.

  4. Efficacy - change in quantitative home reading behaviors [ Time Frame: Change between 6- and 12-month visits compared between groups. ]
    Books in the home, reading frequency and routines (StimQ Reading subscale). Higher score suggests more stimulating reading environment.

  5. Efficacy - digital media use (screen time) [ Time Frame: 12-month visit ]
    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.

  6. Efficacy - change in qualitative home reading behaviors [ Time Frame: Change between 6- and 12-month visits compared between groups. ]
    Shared reading quality/interactivity (SharePR report measure). Higher score suggests higher quality of shared reading. Range is 0-30 points.


Secondary Outcome Measures :
  1. Video Observation of Shared Reading - Reading Quality [ Time Frame: Change between 6- and 12-month visits compared between groups. ]
    A subset of parents (goal 40 per group) will be recruited for video observation of shared reading. Videos will be scored using a structured checklist of SHARE/STEP behaviors, with higher scores reflecting greater interactivity and reading quality.

  2. Video Observation of Shared Reading - Change in Parent-Child Bonding [ Time Frame: Change Between 6- and 12-month visits compared between groups. ]
    A subset of parents (goal 40 per group) will be recruited for video observation of shared reading. Videos will be scored using an established, observation-based measure of parent-child bonding (WECS), with higher scores reflecting greater connection.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   0 Months to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05508282


Contacts
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Contact: Chelsie Edwards 513.517.1256 Chelsie.Edwards@cchmc.org
Contact: Stacey Woeste-Siemer Anastasia.woestesiemer@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John S Hutton, MD    513-636-6721    john1.hutton@cchmc.org   
Contact: Chelsie Edwards       Chelsie.Edwards@cchmc.org   
Principal Investigator: John S Hutton, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: John Hutton, MD Assistant Professor
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT05508282    
Other Study ID Numbers: 2021-0635
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No