Individual, Category, and No-label ConditionsNCT04337372
Infant and Parent Shared Book Reading
A study testing Effects of shared book reading: Labels in people with Individual, Category, and No-label Conditions, run by University of Florida at 1 site in United States.
Trial summary
This work is guided by two specific aims and is expected to result in a better understanding of the effectiveness of shared book reading as a tool for supporting parent-infant interactions and infant learning across the first year of life. Read more about this study
- Who is it for?
- Ages 5 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Individual, Category, and No-label Conditions
- What is being tested?
- Effects of shared book reading: Labels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 14 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Infants will be included if they are typically developing and between 5.5 and 12.5 months of age, as well as their caregiver.
- Parents 18-65 years old
Who cannot join
- Infants who were born more that 14 days premature.
- Infants who with a history of neurological or visual deficits.
- Infants with a history of seizures or a disorder that includes risk of seizures.
- Infants with a parent that has a history of seizures of a disorder that includes risk of seizures.
- Parents with a history of seizures or a disorder that includes risk of seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Brain, Cognition and Development Laboratory
Gainesville, Florida, 32611-2250
About this study
Official title: Parent-infant Learning Dynamics During Early Shared Book Reading
This work is guided by two specific aims and is expected to result in a better understanding of the effectiveness of shared book reading as a tool for supporting parent-infant interactions and infant learning across the first year of life. This work determined the extent to which books with individually-named characters (e.g., "Boris", "Fiona") increases parent-infant joint attention and infant selective attention relative to books with generic labels (e.g., "Bear", "Bear") or no labels and whether attention differs by age. During infant-parent shared book reading joint attention was measured using dual eye-tracking. Infants and parents then returned to the lab the next day and infant selective attention and infant-parent neural synchrony was measured using EEG.
Read the detailed description
Shared book reading has been found to have broad developmental benefits for language, socio-emotional and cognitive development. However, the effects of shared book reading on infant development are not well understood. Although healthcare professionals and educators ask parents to read books to their infants early and often, the book reading experience itself has never been systematically investigated in infancy. This work is guided by two specific aims and is expected to result in a better understanding of the effectiveness of shared book reading as a tool for supporting parent-infant interactions and infant learning across the first year of life. The primary aim of the proposed work is to determine the extent to which books with individually-named characters (e.g., "Boris", "Fiona") increases parent-infant joint attention and infant selective attention relative to books with generic labels (e.g., "Bear", "Bear") or no labels and whether attention differs by age. To address the aim of this project, a cross-sectional sample of 6-, 9-, and 12-month old infants and their parents came to the laboratory and read a book that includes three distinct character labeling conditions (individual names, generic category labels, no label). During infant-parent shared book reading joint attention was measured using dual eye-tracking. Infants and parents then returned to the lab the next day and infant selective attention and infant-parent neural synchrony was measured using EEG frequency tagging while infants and their parent viewed familiar characters across labeling conditions as well as unfamiliar characters. This project determined the extent to which parent-infant shared book reading impacted infant attention, parent-infant joint attention, EEG power, and parent-infant EEG synchrony.
- Being tested
- Effects of shared book reading: Labels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of shared book reading: LabelsBehavioural
Book reading included objects labeled with 1) Individual labels, 2) Category labels, and 3) No Labels. Condition and infant age differences were examined.
| Study group | Role | What they receive |
|---|---|---|
| 6 month olds | Active comparator | 6-month old infants and a parent completed shared book reading and infant visual attention, joint visual attention (dyad, co-occurrence of parent and infant attention toward the book), infant EEG power, and infant-parent EEG coherence were measured in for objects labeled with individual level names, category-level names, and no label. All infant-parent dyads completed all three conditions. Receives: Behavioral: Effects of shared book reading: Labels |
| 9 month olds | Active comparator | 9-month old infants and a parent completed shared book reading and infant visual attention, joint visual attention (dyad, co-occurrence of parent and infant attention toward the book), infant EEG power, and infant-parent EEG coherence were measured in for objects labeled with individual level names, category-level names, and no label. All infant-parent dyads completed all three conditions. Receives: Behavioral: Effects of shared book reading: Labels |
| 12 month olds | Active comparator | 12-month old infants and a parent completed shared book reading and infant visual attention, joint visual attention (dyad, co-occurrence of parent and infant attention toward the book), infant EEG power, and infant-parent EEG coherence were measured in for objects labeled with individual level names, category-level names, and no label. All infant-parent dyads completed all three conditions. Receives: Behavioral: Effects of shared book reading: Labels |
| Adult Parents | Active comparator | Adult parents of infant participants completed shared book reading with their infants. Joint attention and EEG synchrony data were recorded and combined with infant data for analyses. No adult data were analyzed separately from infant data. Receives: Behavioral: Effects of shared book reading: Labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Visual Attention
Infant visual attention was measured for all 3 conditions using head mounted eye-tracking. Duration of visual attention (total duration of infant visual fixations greater than 100 ms each, to the book during shared book reading) was measured within a spatial window of the scene. Proportations of visual attention to the book were calculated by dividing attention duration to the book by the total task duration
Measured: Day 1
Infant EEG Steady-state Evoked Potential Frequency Tagging Power
To examine the extent to which infant EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition and age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions by age group.
Measured: On Day 2
Secondary outcomes (2)
Infant and Parent EEG Synchrony
Infant and parent EEG synchrony (as a dyad) was quantified and compared across conditions. We used a phase-locking index to quantify EEG dyadic synchrony across conditions. The phase-locking index measures the extent to which the parent and infant oscillatory response is in the same phase across time. This index is bounded between 0 and 1, with 1 being perfect synchrony.
Measured: On Day 2
Parent-Infant Visual Joint Attention
Parent and infant visual attention (as a dyad) was measured across conditions using dual parent and infant head mounted eye-tracking. Duration of joint attention (periods of overlap of parent and infant visual fixations to the book during shared book reading) was measured within a spatial window of the scene. Proportions of joint attention were calculated by dividing joint attention duration by the total task duration.
Measured: On Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start8 Feb 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Individual, Category, and No-label ConditionsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There were three age groups tested, but all infant-parent dyads were tested on the same conditions and measures.
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Lisa Scott, Principal investigator, University of FloridaAndreas Keil, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337372
- Sponsor's protocol ID
- IRB202000756-N
- Other IDs
- 1R21HD102715-01, 5R21HD102715-02
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2020
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-infant Learning Dynamics During Early Shared Book Reading
- ClinicalTrials.gov ID
- NCT04337372
- Acronym / sponsor ID
- IRB202000756-N
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work is guided by two specific aims and is expected to result in a better understanding of the effectiveness of shared book reading as a tool for supporting parent-infant interactions and infant learning across the first year of life. This work determined the extent to which books with individually-named characters (e.g., "Boris", "Fiona") increases parent-infant joint attention and infant selective attention relative to books with generic labels (e.g., "Bear", "Bear") or no labels and whether attention differs by age. During infant-parent shared book reading joint attention was measured using dual eye-tracking. Infants and parents then returned to the lab the next day and infant selective attention and infant-parent neural synchrony was measured using EEG.
Detailed description
Shared book reading has been found to have broad developmental benefits for language, socio-emotional and cognitive development. However, the effects of shared book reading on infant development are not well understood. Although healthcare professionals and educators ask parents to read books to their infants early and often, the book reading experience itself has never been systematically investigated in infancy. This work is guided by two specific aims and is expected to result in a better understanding of the effectiveness of shared book reading as a tool for supporting parent-infant interactions and infant learning across the first year of life. The primary aim of the proposed work is to determine the extent to which books with individually-named characters (e.g., "Boris", "Fiona") increases parent-infant joint attention and infant selective attention relative to books with generic labels (e.g., "Bear", "Bear") or no labels and whether attention differs by age. To address the aim of this project, a cross-sectional sample of 6-, 9-, and 12-month old infants and their parents came to the laboratory and read a book that includes three distinct character labeling conditions (individual names, generic category labels, no label). During infant-parent shared book reading joint attention was measured using dual eye-tracking. Infants and parents then returned to the lab the next day and infant selective attention and infant-parent neural synchrony was measured using EEG frequency tagging while infants and their parent viewed familiar characters across labeling conditions as well as unfamiliar characters. This project determined the extent to which parent-infant shared book reading impacted infant attention, parent-infant joint attention, EEG power, and parent-infant EEG synchrony.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There were three age groups tested, but all infant-parent dyads were tested on the same conditions and measures.
| Arm | Type | Receives |
|---|---|---|
| 6 month olds | Active comparator | Behavioral: Effects of shared book reading: Labels6-month old infants and a parent completed shared book reading and infant visual attention, joint visual attention (dyad, co-occurrence of parent and infant attention toward the book), infant EEG power, and infant-parent EEG coherence were measured in for objects labeled with individual level names, category-level names, and no label. All infant-parent dyads completed all three conditions. |
| 9 month olds | Active comparator | Behavioral: Effects of shared book reading: Labels9-month old infants and a parent completed shared book reading and infant visual attention, joint visual attention (dyad, co-occurrence of parent and infant attention toward the book), infant EEG power, and infant-parent EEG coherence were measured in for objects labeled with individual level names, category-level names, and no label. All infant-parent dyads completed all three conditions. |
| 12 month olds | Active comparator | Behavioral: Effects of shared book reading: Labels12-month old infants and a parent completed shared book reading and infant visual attention, joint visual attention (dyad, co-occurrence of parent and infant attention toward the book), infant EEG power, and infant-parent EEG coherence were measured in for objects labeled with individual level names, category-level names, and no label. All infant-parent dyads completed all three conditions. |
| Adult Parents | Active comparator | Behavioral: Effects of shared book reading: LabelsAdult parents of infant participants completed shared book reading with their infants. Joint attention and EEG synchrony data were recorded and combined with infant data for analyses. No adult data were analyzed separately from infant data. |
Who may qualify
- Ages
- 5 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Infants will be included if they are typically developing and between 5.5 and 12.5 months of age, as well as their caregiver.
- Parents 18-65 years old
Key exclusion criteria (5 listed)
- Infants who were born more that 14 days premature.
- Infants who with a history of neurological or visual deficits.
- Infants with a history of seizures or a disorder that includes risk of seizures.
- Infants with a parent that has a history of seizures of a disorder that includes risk of seizures.
- Parents with a history of seizures or a disorder that includes risk of seizures.
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 |
|---|---|---|
| Effects of shared book reading: LabelsBook reading included objects labeled with 1) Individual labels, 2) Category labels, and 3) No Labels. Condition and infant age differences were examined. | Behavioural | 12 month olds, 6 month olds, 9 month olds, Adult Parents |
Primary outcome
Infant Visual Attention
Time frame: Day 1
Infant visual attention was measured for all 3 conditions using head mounted eye-tracking. Duration of visual attention (total duration of infant visual fixations greater than 100 ms each, to the book during shared book reading) was measured within a spatial window of the scene. Proportations of visual attention to the book were calculated by dividing attention duration to the book by the total task duration
Infant EEG Steady-state Evoked Potential Frequency Tagging Power
Time frame: On Day 2
To examine the extent to which infant EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition and age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions by age group.
2 secondary outcomes
Infant and Parent EEG Synchrony
Time frame: On Day 2
Parent-Infant Visual Joint Attention
Time frame: On Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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.
Lisa Scott principal investigator
University of Florida
Andreas Keil, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effects of shared book reading: Labels in people with Individual, Category, and No-label Conditions, run by University of Florida 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 2 inclusion and 5 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 6 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Infant Visual Attention (time frame: Day 1). The study lists 2 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 6 Feb 2025.