NCT05428085

Brief Summary

To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

June 16, 2022

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Surveillance of digital-Media habits in earLy childhood Questionnaire, SMALLQ™

    An survey used to estimate the weekday \& weekend parent-reported on-screen \& off-screen media habits of preschoolers, among other things. The information including three segments: (i) digital media use, parent concern, knowledge and practice of guidelines, outside of school on weekday and weekend; (ii) non-digital media habits: indoor and outdoor play, day time naps, non-screen reading, and drawing; (iii) parent educational attainment and household income, additional child information: height, weight, wearing spectacles or not, and night-time sleep.

    Baseline at first evaluate time

Secondary Outcomes (2)

  • Werry-Weiss Peters Activity Scale Chinese version, WWPAS

    Baseline at first evaluate time

  • Parental stress scale brief Form

    Baseline at first evaluate time

Study Arms (1)

Caregivers whose children are currently receiving early treatment

Individual caregivers were interviewed through paper questionnaires to assess children's and families' digital media usage habits, children's activity levels, and parental stress. Pearson's Chi-Square test and liner regression was used for analysis.

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children who spent screen time more than two hours a day had more significant implicit and explicit behavioral problems, namely withdrawal, nervousness, anxiety, irritability and attention deficit, and restless behavior.

You may qualify if:

  • Caregivers whose children are currently receiving early treatment and who can cooperate with the questionnaire;
  • The child's family has the habit of using digital media devices;
  • The child's main complaints include inattention and impulsivity;
  • The child's age is 3 to 6 years old.

You may not qualify if:

  • The child has other specific diagnosed diseases, such as autism group, sensory disorder, known genetic and genetic diseases, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Location

Related Publications (16)

  • Chia, M., Tay, L. Y., & Chua, T. B. K. (2019). The development of an online surveillance of digital media use in early childhood questionnaire-SMALLQ™-for Singapore.

    BACKGROUND
  • Huang Y, Yan Q, Tong L. Reliability and validity of an observation-based parent-child interaction rating scale for Chinese children aged 0-6 years. Psychol Assess. 2022 May;34(5):e45-e54. doi: 10.1037/pas0001121. Epub 2022 Mar 24.

    PMID: 35324253BACKGROUND
  • Werry-Weiss-Peters Activity Scale, W. W. P. Center for Research in Neuropsychology and Cognitive Behavioral Intervention.

    BACKGROUND
  • Abidin, R. R. (1995). Parenting Stress Index (PSI) manual . Odessa, FL: Psychological Assessment Resources.

    BACKGROUND
  • Tamana SK, Ezeugwu V, Chikuma J, Lefebvre DL, Azad MB, Moraes TJ, Subbarao P, Becker AB, Turvey SE, Sears MR, Dick BD, Carson V, Rasmussen C; CHILD study Investigators; Pei J, Mandhane PJ. Screen-time is associated with inattention problems in preschoolers: Results from the CHILD birth cohort study. PLoS One. 2019 Apr 17;14(4):e0213995. doi: 10.1371/journal.pone.0213995. eCollection 2019.

    PMID: 30995220BACKGROUND
  • Poitras VJ, Gray CE, Janssen X, Aubert S, Carson V, Faulkner G, Goldfield GS, Reilly JJ, Sampson M, Tremblay MS. Systematic review of the relationships between sedentary behaviour and health indicators in the early years (0-4 years). BMC Public Health. 2017 Nov 20;17(Suppl 5):868. doi: 10.1186/s12889-017-4849-8.

    PMID: 29219092BACKGROUND
  • Beal JA. Screen Time and Toddlers: New Evidence on Potentially Negative Effects. MCN Am J Matern Child Nurs. 2020 Jul/Aug;45(4):241. doi: 10.1097/NMC.0000000000000632. No abstract available.

    PMID: 32604184BACKGROUND
  • Radesky JS, Christakis DA. Increased Screen Time: Implications for Early Childhood Development and Behavior. Pediatr Clin North Am. 2016 Oct;63(5):827-39. doi: 10.1016/j.pcl.2016.06.006.

    PMID: 27565361BACKGROUND
  • Madigan S, Browne D, Racine N, Mori C, Tough S. Association Between Screen Time and Children's Performance on a Developmental Screening Test. JAMA Pediatr. 2019 Mar 1;173(3):244-250. doi: 10.1001/jamapediatrics.2018.5056.

    PMID: 30688984BACKGROUND
  • Kids & Tech: Tips for Parents in the Digital Age. HealthyChildren.org. (n.d.). https://www.healthychildren.org/English/family-life/Media/Pages/Tips-for-Parents-Digital-Age.aspx.

    BACKGROUND
  • American Academy of Pediatrics Healthy Children. Org. (2016). How to develop a family media plan [Website]. https://www.healthychildren.org/English/family-life/Media/Pages/How-to-Make-a-Family-Media-Use-Plan.aspx

    BACKGROUND
  • Australian Government Department of Health and Ageing (DoHA) (2011). Get Up and Grow: Healthy Eating and Physical Activity for Early Childhood-Family Book. Retrieved 20 February 2022, from www.health.gov.au/internet/publications/publishing.nsf/Content/gug-family-toc.

    BACKGROUND
  • Xie G, Deng Q, Cao J, Chang Q. Digital screen time and its effect on preschoolers' behavior in China: results from a cross-sectional study. Ital J Pediatr. 2020 Jan 23;46(1):9. doi: 10.1186/s13052-020-0776-x.

    PMID: 31973770BACKGROUND
  • Reid Chassiakos YL, Radesky J, Christakis D, Moreno MA, Cross C; COUNCIL ON COMMUNICATIONS AND MEDIA. Children and Adolescents and Digital Media. Pediatrics. 2016 Nov;138(5):e20162593. doi: 10.1542/peds.2016-2593.

    PMID: 27940795BACKGROUND
  • Vandewater EA, Rideout VJ, Wartella EA, Huang X, Lee JH, Shim MS. Digital childhood: electronic media and technology use among infants, toddlers, and preschoolers. Pediatrics. 2007 May;119(5):e1006-15. doi: 10.1542/peds.2006-1804.

    PMID: 17473074BACKGROUND
  • Rideout, V. (2011). Zero to eight: Children's media use in America. Common Sense Media.

    BACKGROUND

Study Officials

  • Hsinchieh Lee, master

    Taipei Medical University Shuang Ho Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taipei Medical University Shuang Ho Hospital

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 22, 2022

Study Start

June 22, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations