About this trial
Interactive electronic devices (IEDs) have become a common part of young children's lives, yet research on this topic remains limited. Most studies utilise cross-sectional designs and present inconsistent evidence regarding the benefits and harms of IED use. Some findings suggest that IEDs may negatively impact sleep quality, be linked to visual impairment, and lead to reduced and more negative interactions between parents and children. However, it might also have a positive effect in helping language learning in young children when IEDs are co-viewed with parents and improving literacy, mathematics and science skills.
Due to this conflicting evidence, health guidelines for young children do not provide specific recommendations on using these devices, leading policymakers to request more information in this area. In conversation with parents and nursery practitioners, they told us they were confused about the benefits and hams of using these devices and wanted further guidance.
The primary aim of this study is to investigate the long-term association between IED use (duration and mode) and development outcomes in 3-to-5-year-old children. The researchers will also explore the longitudinal association between IED use (duration) and other outcomes, including BMI z-score, movement behaviour, motor skills, parent-child interaction and school readiness.
Children and their parents or caregivers from both low, mid and high-income areas in England will be invited to take part. Children can participate if they are between 3 and 4 years old when they join the study, have received consent from their parent or caregiver, and have provided verbal agreement to participate. However, children will not be eligible if their parents or caregivers do not speak or understand English or if the child has been diagnosed with a developmental disorder by a medical professional before the baseline or follow-up measurements.
Data collection will occur at the start of the study and one year later when children are 4 to 5 years old. Parents will be asked to download an app called EARS on the smartphone and/or tablet that the child uses. The app will measure how long they use the device (IED duration) and the specific apps accessed during device usage (IED mode).
Child development will be assessed through the following measures: 1) working memory, including visual-spatial and phonological aspects; 2) ability to control, referred to as inhibition; 3) the ability to control and redirect attention, defined as shifting; 4) self-regulation; 5) social development; 6) numeracy skills; and 7) expressive vocabulary. Child development will be measured using the Early Years Toolbox app and recorded on an iPad.
The researchers will also measure a set of secondary outcomes, including 1) BMI z-score; 2) 24-hour movement behaviour (i.e. physical activity, sedentary behaviour and sleep); 3) motor development (i.e., gross motor skills and fine motor skills); 4) parent-child interaction; 5) school readiness.
The researchers will also measure other things that might influence IED use or emerging abilities, such as participants' demographics (i.e., sex, age, ethnicity and caregiver education), parenting styles, parents' smartphone addiction, the presence of screen viewing policy at the early year's settings.
To thank the early years settings for participating, each will receive £100 for every data collection session. Parents will receive a £30 high street e-voucher for each data collection session in which they participate. There are no risks of physical injury or harm involved in this study. All researchers entering the nursery will have been subject to an enhanced Disclosure and Barring Service (DBS) check and are permitted to engage in controlled activity. If the research team observes a significant developmental delay in the child while conducting the health and development measures, they will notify the nursery staff, who will then communicate this information to the parents. Parents may feel uncomfortable downloading the app (EARS) onto their electronic devices to track how long the device is being used and the type of apps in use. The app has been designed for research purposes and approved by Sheffield Hallam University Digital Technology Services. Participants will download the app through the official Apple or Google Stores, which offers additional security and convenience. Participants will be advised to delete the app after each data collection point.
The investigators will have regular group meetings throughout the project with parents, carers, nursery teachers and policymakers to gather ideas and opinions and share our findings. These discussions will help researchers improve the project.
The findings will help inform public health guidance on children's device usage. The researchers will share the knowledge gained from this study with all participants, write policy briefs and scientific papers, and present the findings at conferences.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children between 36 and 48 months old at the time of enrolment, who have received parent/carer consent for participation and provided verbal assent
Disqualifiers
Parents or child do not speak and/or understand English.
Child who is clinically diagnosed with a developmental disorder by a medical professional prior to either baseline or follow-up assessments.
Trial population
Participants will be recruited from diverse areas in the Midlands and the North of England. We will utilise two recruitment approaches: 1) through early years settings and 2) directly, using social media, flyers, and engagement with general practitioners (GPs).
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Emerging abilities - composite score (primary outcome)
A z-score will be calculated for each of the developmental outcome variables below, including visual-spatial working memory, phonological working memory, inhibition, shifting, self-regulation and social development, numeracy and mathematical concepts, and expressive vocabulary. The mean z-score will be used to create a composite score called emerging abilities, which is the primary outcome of this study.
Visual-spatial working memory
Visual-spatial working memory, which is the ability to retain and process visual information in memory, will be measured by the 'Mr Ant' task from the Early Years toolbox (Howard et al., 2017).
Phonological working memory
Phonological working memory is the amount of auditory information that concurrently can be coordinated in memory. It will be measured by the 'Not this' task from the Early Years toolbox (Howard et al., 2017).
Inhibition
Inhibition is the ability to control behaviours, urges and impulses, measured by the 'Go/No-Go' task from the Early Years toolbox (Howard et al., 2017).
Secondary outcomes
Height (metres)
Height will be measured to the nearest centimetre using a portable stadiometer.
Weight (kg)
Weight will be measured on a calibrated scale.
BMI Z-score
Weight and height will be combined to calculate the BMI (weight in kilograms (kg) divided by the square of height in meters (m2)), which will then be used to estimate the BMI Z-scores according to the BMI reference curves for the UK (Cole et al. 1995).
24-hour movement behaviour
Children will be advised to continuously wear an accelerometer (Actigraph GT3X-BT) on their right hip for one week to obtain a minimum of three days of at least 16 hours (Fairclough et al., 2023). The accelerometer will provide data on physical activity, sedentary and sleep. The accelerometers will be programmed to record at 30 Hz and downloaded in normal-filtered 15s epochs. We will use R software to process the accelerometer data. We will follow the SADEY data harmonisation protocol for preschoolers to process the data (Cliff et al. 2024). Compositional data analysis will be used to determine the optimal time-use composition of all movement behaviours (i.e. physical activity, sedentary and sleep).
Other outcomes
Age
Age of the child in months
Biological sex
Child biological sex, male or female.
Individual ethnicity
Individual ethnicity with categories divided as White, Asian and other. These categories were defined based on the West Yorkshire Demographics area, which comprises 76.6% White ethnicity, 15.9% Asian and 7.5% other ethnicities.
Community ethnicity congruence
This variable represents the proportion of residents in the child's postcode region who are the same ethnicity as the child.
Sponsors and contacts
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Sheffield Hallam University
Lead sponsor
University of Huddersfield
Collaborator
University of Leeds
Collaborator
University of Strathclyde
Collaborator
Edge Hill University
Collaborator
University of Wollongong
Collaborator
Teesside University
Collaborator