The Effect of Mobile Devices on the Development and Health of Young Children

NCT06810570 | Recruiting DMC

• 2 other identifiers: ER69550320NIHR159040
• Study Type: observational
• Target: 874
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Development and Health; Behavior and Behavior Mechanisms; Cognition; Physical Health; Parent-Child Relations; Education; Technology Use

Keywords

early years; mobile devices; cognitive development; socio emotional development; physical development

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline and repeated 12 months later

• 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).

  Baseline and repeated 12 months later

• 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).

  Baseline and repeated 12 months later

• 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).

  Baseline and repeated 12 months later

• Shifting

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

  Baseline and repeated 12 months later

• Self-regulation and social development

  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.

  Baseline and repeated 12 months later

• Numeracy and mathematical concept

  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.

  Baseline and repeated 12 months later

Secondary Outcomes (15)

• 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

Other Outcomes (9)

• Age

  Baseline and repeated 12 months later

• Biological sex

  Baseline

• Individual ethnicity

  Baseline

Eligibility Criteria

• Age: 36 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead
• University of Huddersfield: collaborator
• University of Leeds: collaborator
• University of Strathclyde: collaborator
• Edge Hill University: collaborator
• University of Wollongong: collaborator
• Teesside University: collaborator

Study Sites (2)

Sheffield Hallam University

Sheffield, S1 1WB, United Kingdom

RECRUITING

Early Years settings

Sheffield, United Kingdom

RECRUITING

Related Publications (16)

• Cliff DP, Antczak D, Draper CE, Olds T, Santos R, Silva DAS, Tremblay MS, van Sluijs EMF, Kemp B, Aadland E, Aadland K, Bezerra TA, Burley J, Carson V, Christian HE, De Craemer M, Downing K, Hesketh KD, Jones RA, Kuzik N, Lehto R, Martins C, Mota J, Nathan A, Okely AD, Roos E, Sousa-Sa E, Vale S, Wiebe S, Janssen I. The sleep and activity database for the early years (SADEY) study: design and methods. J Act Sedentary Sleep Behav. 2024 Jun 18;3(1):15. doi: 10.1186/s44167-024-00054-8.

  PMID: 40217418 BACKGROUND

• StataCorp L. Stata statistical software: Release 17. College Station, TX: StataCorp LP. 2021.

  BACKGROUND

• Charlton C, Rasbash J, Browne WJ, Healy M, Cameron B. MLwiN Version 3.06. Centre for multilevel modelling, University of Bristol. 2022.

  BACKGROUND

• Ward DS, Mazzucca S, McWilliams C, Hales D. Use of the Environment and Policy Evaluation and Observation as a Self-Report Instrument (EPAO-SR) to measure nutrition and physical activity environments in child care settings: validity and reliability evidence. Int J Behav Nutr Phys Act. 2015 Sep 26;12:124. doi: 10.1186/s12966-015-0287-0.

  PMID: 26410387 BACKGROUND

• Robinson CC, Mandleco B, Olsen SF, Hart CH. The parenting styles and dimensions questionnaire (PSDQ). Handbook of family measurement techniques. 2001;3:319-21.

  BACKGROUND

• Kwon M, Kim DJ, Cho H, Yang S. The smartphone addiction scale: development and validation of a short version for adolescents. PLoS One. 2013 Dec 31;8(12):e83558. doi: 10.1371/journal.pone.0083558. eCollection 2013.

  PMID: 24391787 BACKGROUND

• Okely T, Reilly JJ, Tremblay MS, Kariippanon KE, Draper CE, El Hamdouchi A, Florindo AA, Green JP, Guan H, Katzmarzyk PT, Lubree H, Pham BN, Suesse T, Willumsen J, Basheer M, Calleia R, Chong KH, Cross PL, Nacher M, Smeets L, Taylor E, Abdeta C, Aguilar-Farias N, Baig A, Bayasgalan J, Chan CHS, Chathurangana PWP, Chia M, Ghofranipour F, Ha AS, Hossain MS, Janssen X, Jauregui A, Katewongsa P, Kim DH, Kim TV, Koh D, Kontsevaya A, Leyna GH, Lof M, Munambah N, Mwase-Vuma T, Nusurupia J, Oluwayomi A, Del Pozo-Cruz B, Del Pozo-Cruz J, Roos E, Shirazi A, Singh P, Staiano A, Suherman A, Tanaka C, Tang HK, Teo WP, Tiongco MM, Tladi D, Turab A, Veldman SLC, Webster EK, Wickramasinghe P, Widyastari DA. Cross-sectional examination of 24-hour movement behaviours among 3- and 4-year-old children in urban and rural settings in low-income, middle-income and high-income countries: the SUNRISE study protocol. BMJ Open. 2021 Oct 25;11(10):e049267. doi: 10.1136/bmjopen-2021-049267.

  PMID: 34697112 BACKGROUND

• Cates CB, Roby E, Canfield CF, Johnson M, Raak C, Weisleder A, Dreyer BP, Mendelsohn AL. Validation of the StimQ2: A parent-report measure of cognitive stimulation in the home. PLoS One. 2023 Jul 24;18(7):e0286708. doi: 10.1371/journal.pone.0286708. eCollection 2023.

  PMID: 37486914 BACKGROUND

• Wade NE, Ortigara JM, Sullivan RM, Tomko RL, Breslin FJ, Baker FC, Fuemmeler BF, Delrahim Howlett K, Lisdahl KM, Marshall AT, Mason MJ, Neale MC, Squeglia LM, Wolff-Hughes DL, Tapert SF, Bagot KS; ABCD Novel Technologies Workgroup. Passive Sensing of Preteens' Smartphone Use: An Adolescent Brain Cognitive Development (ABCD) Cohort Substudy. JMIR Ment Health. 2021 Oct 18;8(10):e29426. doi: 10.2196/29426.

  PMID: 34661541 BACKGROUND

• Bagot KS, Tomko RL, Marshall AT, Hermann J, Cummins K, Ksinan A, Kakalis M, Breslin F, Lisdahl KM, Mason M, Redhead JN, Squeglia LM, Thompson WK, Wade T, Tapert SF, Fuemmeler BF, Baker FC. Youth screen use in the ABCD(R) study. Dev Cogn Neurosci. 2022 Oct;57:101150. doi: 10.1016/j.dcn.2022.101150. Epub 2022 Sep 1.

  PMID: 36084446 BACKGROUND

• Howard SJ, Melhuish E. An Early Years Toolbox for Assessing Early Executive Function, Language, Self-Regulation, and Social Development: Validity, Reliability, and Preliminary Norms. J Psychoeduc Assess. 2017 Jun;35(3):255-275. doi: 10.1177/0734282916633009. Epub 2016 Feb 28.

  PMID: 28503022 BACKGROUND

• Clark JE, Pate R, Rine RM, Christy J, Dalton P, Damiano DL, Daniels S, Holmes JM, Katzmarzyk PT, Magasi S, McCreery R, McIver K, Newell KM, Sanger T, Sugden D, Taveras E, Hirschfeld S. NCS Assessments of the Motor, Sensory, and Physical Health Domains. Front Pediatr. 2021 Nov 26;9:622542. doi: 10.3389/fped.2021.622542. eCollection 2021.

  PMID: 34900852 BACKGROUND

• Reuben DB, Magasi S, McCreath HE, Bohannon RW, Wang YC, Bubela DJ, Rymer WZ, Beaumont J, Rine RM, Lai JS, Gershon RC. Motor assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S65-75. doi: 10.1212/WNL.0b013e3182872e01.

  PMID: 23479547 BACKGROUND

• Fairclough SJ, Clifford L, Brown D, Tyler R. Characteristics of 24-hour movement behaviours and their associations with mental health in children and adolescents. J Act Sedentary Sleep Behav. 2023;2(1):11. doi: 10.1186/s44167-023-00021-9. Epub 2023 Jun 2.

  PMID: 38013786 BACKGROUND

• Cole TJ, Freeman JV, Preece MA. Body mass index reference curves for the UK, 1990. Arch Dis Child. 1995 Jul;73(1):25-9. doi: 10.1136/adc.73.1.25.

  PMID: 7639544 BACKGROUND

• De Azevedo LB, Stephenson J, Hughes A, Retzler J, Reilly JJ, Fairclough S, Okely T, Jones D, Smith C, Greca JPA, Marr C. iKids study protocol: a longitudinal study to understand the impact of interactive electronic devices on the development and health of young children in England. BMJ Open. 2025 Aug 1;15(7):e101523. doi: 10.1136/bmjopen-2025-101523.

  PMID: 40750289 DERIVED

Related Links

• Project website
• Funders webpage of the project

MeSH Terms

Conditions

Behavior

Study Officials

• Liane Beretta de Azevedo, Professor

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liane Beretta de Azevedo, Professor

CONTACT

+44 (0) 114 225 5571; l.azevedo@shu.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 5, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We plan to deposit the data at the Sheffield Hallam Research Data Archive (SHURDA) in September 2027. The data will be securely archived in SHURDA for 10 years, starting from the last time a third party requests access. After this period, all data will be deleted from the Research Store.
• Access Criteria: Fully anonymised data will also be deposited in an open-access repository (SHRUDA) under a CC-BY license as guided by the research funder NIHR. Requests can be made directly to SHRUDA (library-research-support@shu.ac.uk). When depositing the data, no further changes to the formatting will be necessary, as all required actions will be carried out as the research progresses. All data will be stored in CSV (comma-separated values) format. CSV files are compatible with many software applications, allowing potential users to easily store and reuse the data. The Data Management and Access Plan submitted to the funders (NIHR) can be accessed through the URL below. Please note that the data management described in this link pertains to all three work packages of the project: WP1 - Systematic Review, WP2 - Longitudinal Study, and WP3 - Qualitative Study. However, the registration provided here specifically refers only to WP2 - Longitudinal Studies.

Locations

GB (2)