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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04337372
Other study ID # IRB202000756-N
Secondary ID 1R21HD102715-015
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2022
Est. completion date December 14, 2023

Study information

Verified date June 2024
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 first aim of the proposed research is to determine the extent to which infant and parent visual attentional coupling during shared book reading predicts later: a) infant selective attention and b) infant and parent neural coupling. The second 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 aims of this project, a cross-sectional sample of 6-, 9-, and 12-month old infants and their parents will come 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 will be measured using dual eye-tracking. Infants and parents will then return to the lab the next day and infant selective attention and infant-parent neural synchrony will be measured using EEG frequency tagging while infants and their parent view familiar characters across labeling conditions as well as unfamiliar characters. If the aims of the proposed research are achieved, we will have determined the extent to which parent-infant joint attention prompts subsequent selective processing of book content in 6-, 9-, and 12-month old infants.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date December 14, 2023
Est. primary completion date December 14, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Months to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: 1. Infants who were born more that 14 days premature. 2. Infants who with a history of neurological or visual deficits. 3. Infants with a history of seizures or a disorder that includes risk of seizures. 4. Infants with a parent that has a history of seizures of a disorder that includes risk of seizures. 5. Parents with a history of seizures or a disorder that includes risk of seizures.

Study Design


Related Conditions & MeSH terms

  • Shared Book Reading With Specifically Named Characters v. Generically Named Characters v. no Book Control

Intervention

Behavioral:
Book reading
Parent and their infant will read a short book in the laboratory. Books will include three labeling conditions expected to elicit different levels of attention.

Locations

Country Name City State
United States University of Florida Brain, Cognition and Development Laboratory Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infant Visual Fixations Infant visual fixations will be recorded during shared book reading and duration of attention and joint attention calculated. Three age groups will be examined (6-, 9-, and 12-month olds). On Day 1
Secondary Parent Visual Fixations In the lab, parent visual attention will be measured across conditions using a head mounted eye-tracker. Duration of joint attention within a spatial window will be calculated in conjunction with infant visual fixations. On Day 1
Secondary Infant EEG steady-state evoked potential frequency tagging power Infant EEG power will be measured and compared across conditions and ages during a ssVEP frequency tagging task. We will examine the ssVEP power evoked by two overlapping visual objects to quantify the degree of visual attention devoted to learned characters relative to novel characters across labeling conditions. On Day 2
Secondary Infant and parent EEG synchrony with steady-state evoked potential power Infant and parent EEG synchrony will be quantified and compared across conditions.We will use magnitude squared coherence and phase-locking index to quantify EEG dyadic synchrony under viewing conditions in which the phase of brain oscillations is constrained by external stimulation (i.e., Steady-State Evoked Potential power (ssVEP) Frequency Tagging Task) and we will compare within-subject conditions. On Day 2