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临床试验/NCT06810570
NCT06810570招募中不适用

Understanding the Impact of Interactive Electronic Devices on Young Children's Development and Health: the iKids Study

Sheffield Hallam University2 个研究点 分布在 1 个国家目标入组 874 人开始时间: 2025年1月13日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
874
试验地点
2
主要终点
Emerging abilities - composite score (primary outcome)

研究概览

简要总结

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.

详细描述

Quality assurance Researchers undertaking the measurements are highly experienced in the procedures and analysis. The investigators are utilising only validated tools that are well-established in the literature. The exposure and use of interactive electronic devices (e.g., tablets and smartphones) will be measured by an app that will access information directly from the participant's devices (Android or iOS) using mobile sensing software to capture screen time and app usage (Lind et al. 2023). The app has been successfully used to measure smartphone use in children (Bagot et al., 2022; Wade et al., 2021).

The measurement of emerging abilities, our primary outcome measure, has been validated and widely used in the literature (Howard et al. 2017). The investigators will use an administration fidelity checklist to assess practice across researchers before the start of data collection. A range of secondary outcomes will be recorded (i.e. BMI (calibrated scales and repeated measures), movement behaviour (accelerometry Cliff et al. 2024), motor development (NIH toolbox, Reuben et al., 2013), parent and child interaction (StimQ2, Cates et al. 2023). These measurements have been used in the SUNRISE study, which is collecting data on children at this age in 63 countries around the world (https://sunrise-study.com/) and published in a protocol (Okely et al., 2021).

Training videos and support have been provided by the SUNRISE team and have been used to inform our study protocol. Since child development is influenced by a number of covariates, the investigators have selected the most commonly reported in the literature and suggested by our PPI group (i.e. sex, age, ethnicity, maternal education, parenting style (PSDQ- SV. Robinson et al. 2001), attendance to childcare, parental addiction to smartphones (SAS-SV, Kwon et al., 2013) and screen viewing policy.

Data processing Data capture forms have been created for applicable measures to standardise data input and aid with data entry. In terms of data processing and analysis. The investigators will conduct preliminary data cleaning, exploring whether values of continuous variables are within range, plausibility of means and standard deviations, and validity of coded categories. The investigators will assess data distributions and identify any univariate outliers from graphical methods and from cases with very large, standardised scores disconnected from other scores and multivariate outliers by graphical methods and inspection of leverage/Mahalanobis distances, discrepancy and influence statistics. Any possible errors will be investigated on an individual basis. The investigators will also investigate the extent, pattern and nature of missing data. If the proportion of missing data is small (below 5%), they will consider complete case analyses. If the amount or pattern of missing data precludes complete case analysis, the investigators will consider data imputation. Multiple imputations will be used due to their robustness to the type of data missingness. If imputation is conducted, sensitivity studies will be conducted by comparing results derived from data with and without imputation.

Data analysis Descriptive analysis The sample will be summarised descriptively. The investigators will report the number of children in each educational unit and primary and secondary outcomes by time point (baseline and follow-up). For continuous outcomes, summary information will be presented as means (standard deviations (SD); ranges). For categorical outcomes, summary information will be presented as frequencies (percentages). The need for variable transformations to stabilise variance or achieve Normality will be assessed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
36 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 36 and 48 months old at the time of enrolment, who have received parent/carer consent for participation and provided verbal assent

排除标准

  • 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.

结局指标

主要结局

Emerging abilities - composite score (primary outcome)

时间窗: Baseline and repeated 12 months later

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

时间窗: Baseline and repeated 12 months later

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

时间窗: Baseline and repeated 12 months later

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

时间窗: Baseline and repeated 12 months later

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).

Shifting

时间窗: Baseline and repeated 12 months later

Shifting is the ability to control and redirect attention, measured by the 'Card Sorting' task from the Early Years toolbox (Howard et al., 2017).

Self-regulation and social development

时间窗: Baseline and repeated 12 months later

Self-regulation and social development will be measured by the 34- items questionnaire Child Self-Regulation \& Behaviour Questionnaire from the Early Years toolbox (Howard et al., 2017). The questionnaire contains subscales to assess cognitive, behavioural and emotional self-regulation, and sociability, prosocial behaviour, externalising problems and internalising problems.

Numeracy and mathematical concept

时间窗: Baseline and repeated 12 months later

Numeracy and mathematical concepts will be assessed by the 'Early Numeracy' task from the Early Years toolbox (Howard et al., 2017). The test will measure numeracy skills, such as numerical language, spatial and measurement concepts, counting, matching digits and quantities, completing number lines, ordinality, subitising, patterning, numerical word problems and equations.

次要结局

  • Height (metres)(Baseline and repeated 12 months later)
  • Weight (kg)(Baseline and repeated 12 months later)
  • BMI Z-score(Baseline and repeated 12 months later)
  • 24-hour movement behaviour(Baseline and repeated 12 months later)
  • Physical Activity(Baseline and repeated 12 months later)
  • Sedentary Behaviour(Baseline and repeated 12 months later)
  • Total sleep(Baseline and repeated 12 months later)
  • Lower body strength(Baseline and repeated 12 months later.)
  • Mobility and posture(Baseline and repeated 12 months later.)
  • Posture and Balance(Baseline and repeated 12 months later.)
  • Upper body strength(Baseline and repeated 12 months later)
  • Fine motor skills(Baseline and repeated 12 months later)
  • Total motor skills(Baseline and repeated 12 months later)
  • Parent-child interaction(Baseline and repeated 12 months later)
  • School readiness(Measured only at follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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