LiteracyNCT05508282
Testing an App-Based Approach to Reading and Screen Time Guidance for Parents of Infants
A study testing Reading Bees app and children's book to enhance parent-infant reading quality (0-2 month visit) and Reading Bees app and children's book to encourage alternatives to digital media (6-month visit) in people with Literacy and Parent-Child Relations, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Literacy, Parent-Child Relations, Language Development
- What is being tested?
- Reading Bees app and children's book to enhance parent-infant reading quality (0-2 month visit) and Reading Bees app and children's book to encourage alternatives to digital media (6-month visit)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Violating the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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
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.
Read the 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.
- Conditions
- Literacy, Parent-Child Relations, Language Development
- Being tested
- Reading Bees app and children's book to enhance parent-infant reading quality (0-2 month visit), Reading Bees app and children's book to encourage alternatives to digital media (6-month visit)
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading Bees app and children's book to enhance parent-infant reading quality (0-2 month visit)Behavioural
The reading intervention will be provided at the baseline clinic well-visit (0-2 months), and is based on the SHARE/STEP approach.
Reading Bees app and children's book to encourage alternatives to digital media (6-month visit)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Feasibility of Reading Bees app for reading and screen time guidance; includes time of presentation and barriers encountered
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change between 6- and 12-month visits compared between groups.
Secondary outcomes (2)
Video Observation of Shared Reading - Reading Quality
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.
Measured: Change between 6- and 12-month visits compared between groups.
Video Observation of Shared Reading - Change in Parent-Child Bonding
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.
Measured: Change Between 6- and 12-month visits compared between groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start30 Jun 2022
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Hutton, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508282
- Sponsor's protocol ID
- 2021-0635
- Status last verified
- Jul 2024
- First submitted
- 22 Feb 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05508282
- Acronym / sponsor ID
- 2021-0635
- Conditions
- Literacy, Parent-Child Relations, Language Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind randomized trial with two arms: intervention (enhanced reading \& screen time guidance using a new mobile app) and control (usual guidance).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | 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)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 |
| 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. |
Who may qualify
- Ages
- 0 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Violating the above inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
| 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). | Behavioural | Intervention |
Primary outcome
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
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.
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.
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.
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.
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.
2 secondary outcomes
Video Observation of Shared Reading - Reading Quality
Time frame: Change between 6- and 12-month visits compared between groups.
Video Observation of Shared Reading - Change in Parent-Child Bonding
Time frame: Change Between 6- and 12-month visits compared between groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hutton, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading Bees app and children's book to enhance parent-infant reading quality (0-2 month visit) and Reading Bees app and children's book to encourage alternatives to digital media (6-month visit) in people with Literacy and Parent-Child Relations, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: Baseline visit (0-2 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.